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ABBV-951

Phase 3

Parkinson's Disease (PD) | Small molecule | Neurology |AbbVie Inc.|Last Updated: Jun 1, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials6
Total Enrollment715
FDA Designations
No designations recorded
Clinical Trials (6)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04750226Study To Assess Adverse Events and Change in Disease Activity Of 24-hour Continuous Subcutaneous Infusion Of ABBV-951 In Adult Participants With Advanced Parkinson's DiseasePHASE3 COMPLETED 118Feb 18, 2021Apr 27, 2026Jun 1, 202652 United States, Australia
NCT04380142Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkinson's DiseasePHASE3 COMPLETED 174Oct 19, 2020Sep 29, 2021Nov 18, 202276 United States, Australia
NCT04379050Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's DiseasePHASE3 COMPLETED 130Jun 8, 2020Apr 17, 2026May 13, 202651 United States, Australia +11
NCT03781167A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)PHASE3 COMPLETED 244Apr 29, 2019Aug 17, 2022Oct 23, 202365 United States, Australia +11
NCT03374917A Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 in an Outpatient EnvironmentPHASE1 COMPLETED 20Apr 18, 2018Mar 4, 2019Nov 12, 202412 United States
NCT03033498A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Infusions of ABBV-951 in Subjects With Parkinson's DiseasePHASE1 COMPLETED 29May 17, 2017Jun 8, 2019Nov 12, 20247 United States
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Study Endpoints
Primary Endpoints
Percentage of Participants with Adverse Event (AEs)
Up to Week 96

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An SAE is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.

Percentage of Participants with AEs of Special Interest (AESIs)
Up to Week 96

AESIs are defined as AEs from "special situations," such as accidental or intentional overdose, medication error, occupational or accidental exposure, off-label use, drug abuse, drug misuse, or drug withdrawal, all which must be reported whether associated with an AE or not.

Percentage Of Participants With Numeric Grade Equal To Or Higher Than 5 On The Infusion Site Evaluation Scale
Up To Week 96

The Infusion Site Evaluation Scale will be used to assess infusion sites. Infusion Site Evaluation Scale is an eight-point numeric scale used to assess irritation at the infusion site area (0 being "no evidence of irritation" and 7 being "strong reaction spreading beyond the test site").

Percentage Of Participants With Letter Grade Equal To Or Higher Than D On The Infusion Site Evaluation Scale
Up To Week 96

The Infusion Site Evaluation Scale will be used to assess infusion sites. Infusion Site Evaluation Scale is an A to G letter grade scale, used to assess irritation at the infusion site area (A being "no finding" to G being "Small petechial erosions and/or scabs").

Change From Baseline in Suicidality as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Up To Week 96

C-SSRS is a systematically administered instrument designed to assess suicidal behavior and ideation, track and assess all suicidal events, and assess the lethality of attempts. Any participant who has suicidal behavior or suicidal ideation with plan since the last C-SSRS completed, will be evaluated immediately by the investigator.

Change From Baseline in Impulsive-Compulsive Disorders and related behaviors as assessed in Parkinson's Disease- Rating Scale (QUIP-RS)
Up To Week 96

The QUIP-RS is a brief, self-completed or rater-administered rating scale to assess the severity of symptoms of impulse control disorders (ICDs) and related behaviors reported to occur in PD. The QUIP-RS uses a 5-point Likert scale that requires individuals to rate the severity of each symptom based on its frequency.

Change From Baseline in Cognitive Impairment as Assessed by the Mini-Mental State Examination (MMSE)
Up To Week 96

Cognitive impairment is assessed by the Mini-Mental State Examination (MMSE). MMSE is a brief 30-point questionnaire, administered by a trained rater, that provides a quantitative measure of cognitive status in adults and is used widely to screen for cognitive impairment and to estimate the severity of cognitive impairment at a given point in time, to follow the course of changes in a patient over time, and to document response to treatment.

Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed.
Up to Week 96

Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed..

Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements like Systolic and Diastolic Blood Pressure will be Assessed
Up to Week 96

Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.

Change From Baseline in Electrocardiograms (ECGs)
Up to Week 96

12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.

Change From Baseline to Week 12 of the Double-Blind Treatment Period in Average Daily Normalized "On" Time Without Troublesome Dyskinesia
Baseline (Week 0) up to Week 12 of the double-blind treatment period

"On" time is defined as periods of good motor symptom control, and was assessed by the Parkinson's Disease (PD) diary. The normalized "On" time without troublesome dyskinesia is the sum of the normalized "On" time without dyskinesia and the normalized "On" time with non-troublesome dyskinesia. "On" time without dyskinesia plus "On" time with non-troublesome dyskinesia are based on the PD Diary (normalized to a 16-hour waking day averaged over 3 consecutive days). Baseline value is defined as the average of normalized "On" time without troublesome dyskinesia collected over the 3 PD Diary days before randomization.

Percentage of Participants With Adverse Events (AE)
Up To Week 96

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of the study drug or device as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Adverse Events of Special Interest (AESI) - polyneuropathy, weight loss, hallucinations/psychosis, and somnolence will be monitored throughout the study.

Change in Clinical Laboratory Test Data
Up To Week 96

Number of participants with clinically significant change from baseline in laboratory parameters (hematology, biochemistry, coagulation, and urinalysis) will be reported throughout the study.

Change in Vital Signs Measurements
Up To Week 96

Number of participants with clinically significant change from baseline in vital signs will be reported throughout the study.

Number of Participants With Adverse Events
From first dose of study drug until 30 days following last dose of study drug (up to 480 days)

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

Number of Participants With Adverse Events of Special Interest
From first dose of study drug until 30 days following last dose of study drug (up to 480 days)

Treatment emergent adverse events of special interest are defined as any adverse event of infusion site infections, infusion site reactions, hallucinations/psychosis, falls and associated injuries, polyneuropathy (peripheral neuropathy), weight loss, or somnolence from the first dose of study drug until 30 days following last dose of study drug.

Number of Participants With Numeric Grade Equal to or Higher Than 5 and With Letter Grade Equal to or Higher Than D on the Infusion Site Evaluation Scale
Day 1, Day 2, Week 1, Week 2, Week 3, Week 4, Week 6, Week 13, Week 26, Week 39, and Week 52

Skin tolerability was assessed using the Infusion Site Evaluation Scale, a 2-part numeric (0-7) and letter (A-G) grade scale, where a notable skin reaction is defined as a reaction with a numeric grade of 6 or 7 or a letter grade of D, E, F, or G. Any observation of infusion site reaction with irritation criteria \> 2 or \> C was recorded as an adverse event (AE).

Hematocrit (Hematology): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Hemoglobin (Hematology): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Neutrophils (Hematology): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Lymphocytes (Hematology): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Monocytes (Hematology): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Absolute Platelet Count (Hematology): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Creatinine (Clinical Chemistry): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Sodium (Clinical Chemistry): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Potassium (Clinical Chemistry): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Calcium (Clinical Chemistry): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Uric Acid (Clinical Chemistry): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Albumin (Clinical Chemistry): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Glucose (Clinical Chemistry): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Magnesium (Clinical Chemistry): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Creatinine Clearance (Clinical Chemistry): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Homocysteine (Clinical Chemistry): Change From Baseline to End of Study
Baseline, Weeks 6, 26, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study
Baseline, Weeks 6, 26, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study
Baseline, Weeks 6, 26, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

pH (Urinalysis): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Specific Gravity (Urinalysis): Change From Baseline to End of Study
Baseline, Weeks 6, 26, 39, and 52

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)

Orthostatic blood pressure was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.

Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)

Orthostatic blood pressure was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.

Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study
Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)

Orthostatic pulse rate was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.

Electrocardiogram (ECG) Mean Heart Rate: Change From Baseline to End of Study
Baseline, Day 1 (postdose), Weeks 6 and 52

12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.

Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study
Baseline, Day 1 (postdose), Weeks 6 and 52

12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.

Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study
Baseline, Day 1 (postdose), Weeks 6 and 52

12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.

Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study
Baseline, Day 1 (postdose), Weeks 6 and 52

12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.

Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study
Baseline, Day 1 (postdose), Weeks 6 and 52

12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.

Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study
Baseline, Day 1 (postdose), Weeks 6 and 52

12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.

Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study
Baseline, Day 1 (postdose), Weeks 6 and 52

12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.

Percentage of Participants with Infusion Site Reactions
28 Days

Local tolerability (infusion site evaluation) was assessed using the Infusion Site Assessment 2-part rating scale.

Percentage of Participants with Markedly Abnormal Vital Signs Values
28 days

Vital signs will be collected both supine and standing.

Columbia-Suicide Severity Rating Scale (C-SSRS)
28 days

The C-SSRS is an instrument designed to assess suicidal behavior and ideation.

Percentage of Participants with Potentially Clinically Significant Laboratory Values
28 days

Blood samples for serum chemistry tests will be collected following a minimum 8-hour fast.

Percentage of Participants with Potentially Clinically Significant Electrocardiogram (ECG) Results
28 days

A 12-lead ECG will be performed after the participant has been supine for at least 5 minutes.

Maximum Observed Plasma Concentration (Cmax) of Levodopa
Hour 0-24

Maximum observed plasma concentration of levodopa following a single infusion of ABBV-951.

Time to maximum observed plasma concentration (Tmax) of Levodopa
Hour 0-24

Time to maximum observed plasma concentration of levodopa following a single infusion of ABBV-951.

Area Under the Plasma Concentration-Time Curve (AUC) of Levodopa
Hour 0-24

Area under the plasma concentration-time curve following a single infusion of ABBV-951.

Adverse Events
24 hours

Number of participants reporting adverse events

Terminal phase elimination rate constant (β)
Up to 72 hours

Apparent terminal phase elimination rate constant (β or Beta)

Terminal phase elimination half-life (T1/2)
Up to 72 hours

Terminal phase elimination half-life (t1/2) will be assessed.

Secondary Endpoints
Change From Baseline in Average Normalized "On" Time as Assessed by the Parkinson's Disease (PD) Diary
Up To Week 96
Change From Baseline in Average Daily Normalized "Off" Time as Assessed by the PD Diary
Up To Week 96
Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part I
Up To Week 96
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ABBV-951EXPERIMENTALParticipants will receive ABBV-951 by continuous subcutaneous infusion (CSCI) for 96 weeks during the Primary Treatment Period and during the optional Extended Treatment Period.
ABBV-951 + Placebo for Levodopa/Carbidopa (LD/CD)EXPERIMENTALAfter an open-label LD/CD Stabilization Period, participants will receive double-blind ABBV-951 by continuous subcutaneous infusion (CSCI) and oral placebo for LD/CD for 12 weeks
Levodopa/Carbidopa (LD/CD) + Placebo for ABBV-951ACTIVE_COMPARATORAfter an open-label LD/CD Stabilization Period, participants will receive double-blind oral LD/CD and CSCI of placebo for ABBV-951 for 12 weeks
ABBV-951 Low Dose SubgroupEXPERIMENTALAfter a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
ABBV-951 High Dose SubgroupEXPERIMENTALAfter a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
ABBV-951 Dose 1EXPERIMENTALParticipants will receive dose 1 of ABBV-951.
ABBV-951 Dose 2EXPERIMENTALParticipants will receive dose 2 of ABBV-951.
ABBV-951 Dose 3EXPERIMENTALParticipants will receive dose 3 of ABBV-951.
ABBV-951 Dose 4EXPERIMENTALParticipants will receive dose 4 of ABBV-951.
ABBV-951 Dose 5EXPERIMENTALParticipants will receive dose 5 of ABBV-951.
ABBV-951 Dose 6EXPERIMENTALParticipants will receive dose 6 of ABBV-951.
ABBV-951 Dose 7EXPERIMENTALParticipants will receive dose 7 of ABBV-951.
ABBV-951 Dose 8EXPERIMENTALParticipants will receive dose 8 of ABBV-951.
Interventions
NameTypeDescription
ABBV-951DRUGSolution for continuous subcutaneous infusion (CSCI).
Placebo for Levodopa/Carbidopa (LD/CD)DRUGOral capsule
Levodopa/Carbidopa (LD/CD)DRUGOral encapsulated tablet
Placebo for ABBV-951DRUGSolution for continuous subcutaneous infusion (CSCI)
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Eligibility Criteria
Age Range30 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites52

Inclusion Criteria: \- Completion of the parent study, Study M15-736 or Study M20-339. Exclusion Criteria: \- Participant considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason.

Countries:United StatesAustraliaBelgiumCanadaDenmarkGermanyItalyJapanNetherlandsRussiaSpainSwedenUnited Kingdom
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Recent Changes (Last 90 Days)
HIGHJun 2, 2026NCT04750226Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJun 2, 2026NCT04750226Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJun 2, 2026NCT04750226Status: ACTIVE_NOT_RECRUITING → COMPLETED
LOWMay 26, 2026NCT04750226primaryCompletionDate: changed
HIGHMay 26, 2026NCT04379050Status: ACTIVE_NOT_RECRUITING → COMPLETED
LOWMay 24, 2026NCT04750226studyFirstPostDate: changed
LOWMay 24, 2026NCT04379050studyFirstPostDate: changed