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ABT-SLV187

Phase 3

Advanced Parkinson's Disease | Small molecule | Neurology |AbbVie Inc.|Last Updated: May 12, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials2
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02082249An Extension Study to Assess the Safety, Tolerability and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian MedicationsPHASE3 COMPLETED 30Mar 10, 2014Oct 31, 2019May 12, 20217 Japan, South Korea +1
NCT01479127Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's DiseasePHASE2 COMPLETED 8Oct 1, 2011Jul 1, 2012Apr 21, 2016 -
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Study Endpoints
Primary Endpoints
Number of Participants with Adverse Events
From Day 1 up to 6 years (estimated maximum)

All negative changes in health during the study will be treated and recorded during the study.

Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation During the Run-in Period
During the Run-in period (up to approximately 28 days)

AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with this treatment. SAE: an event that results in the death of a subject, is life threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity, or other important medical event. Severity was rated as mild, moderate, or severe. AEs of special interest included: device-associated gastrointestinal disorders; cardiovascular fatalities; aspiration including aspiration pneumonia; a diagnosis of peripheral polyneuropathy (axonal, demyelinating or mixed type); possible symptoms of peripheral polyneuropathy; clinically significant weight loss. 'AEs at least possibly related' are defined as those that were assessed by investigator as probably related or possibly related.

Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation During the ABT-SLV187 Treatment Period
From NJ placement to end of ABT-SLV187 Treatment Period (Day 21) +30 days

AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with this treatment. SAE: an event that results in the death of a subject, is life threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity, or other important medical event. Severity was rated as mild, moderate, or severe. AEs of special interest included: device-associated gastrointestinal disorders; cardiovascular fatalities; aspiration including aspiration pneumonia; a diagnosis of peripheral polyneuropathy (axonal, demyelinating or mixed type); possible symptoms of peripheral polyneuropathy; clinically significant weight loss. 'AEs at least possibly related' are defined as those that were assessed by investigator as probably related or possibly related.

Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period
Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

M=male, F=female, MCV=mean corpuscular volume, MCH=mean corpuscular hemoglobin, MCHC=mean corpuscular hemoglobin concentration.

Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period
Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

M=male, F=female, γ-GTP=gamma-glutamyl transpeptidase.

Number of Participants With PCS Values in Special Laboratory Parameters During the ABT-SLV187 Treatment Period
Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

M=male, F=female

Number of Participants With Potentially Clinically Significant Urinalysis Results During the ABT-SLV187 Treatment Period
Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Number of Participants With Potentially Clinically Significant (PCS) Vital Signs Results During the ABT-SLV187 Treatment Period
Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

↓=decrease, ↑=increase, BL=baseline, temp.=temperature, SBP=systolic blood pressure, Sup.=supine, Sta.=standing, DBP=diastolic blood pressure.

Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Results During the ABT-SLV187 Treatment Period
Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

High potentially clinically significant Bazett's heart rate-corrected QT interval (QTcB) values were: 450 msec for males / 470 msec for females.

Mean Change From Baseline to the End of Treatment in Percentage of Ratings in the "Normal" State on the Treatment Response Scale (TRS) I
Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

Participants were video recorded a total of 10 times for 1 to 2 minutes every 60 minutes while performing a standardized sequence of motor tasks: rest, finger taps, rapid alternating movement of hands, arising from chair and gait, including confirmation of postural stability. Based on these video recordings, a Video Evaluation Committee consisting of 3 neurologists individually evaluated the following Video Assessment and Treatment Response Scale (TRS) under blinded conditions: Finger Taps, Rapid Alternating Movement of Hands, Arising from Chair, Gait, Body Bradykinesia and Hypokinesia, Dyskinesia. The average of the neurologists' evaluations was calculated as a percentage of ratings in the "Normal" state (ie, "mild OFF" to "ON with mild dyskinesia") on the TRS I (total 10 assessments per day).

Secondary Endpoints
Change in Patient Global Impression of Change (PGIC) scores
From Screening Visit 2 of M12-921 to Week 52 of M12-923
Change in the Unified Parkinson's Disease Rating Scale (UPDRS) score
From Day 1 up to 36 months (estimated maximum)
Change in the Parkinson's Disease Questionnaire-39 (PDQ-39) scores
From Screening Visit 2 of M12-921 to Week 52
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ABT-SLV187EXPERIMENTALup to 6 years
Levodopa-carbidopa intestinal gelEXPERIMENTALFollowing a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
Interventions
NameTypeDescription
ABT-SLV187DRUGDose levels will be individually optimized
Oral Levodopa/CarbidopaDRUGTablet; contains 100 mg levodopa and 10 mg carbidopa
Infusion Pump: CADD-Legacy® 1400 PumpDEVICEGeneral infusion pump, manufactured by Smiths Medical (US)
NJ-Tube: Silicon ED TubeDEVICEDevice used to deliver nutrition/drug to stomach/intestine or to aspirate stomach fluid, manufactured by Create Medic Co., Ltd. (Japan)
Adaptor: Hakko AdaptorDEVICEAccessory set for fluid infusion set, consisting of caps, connectors and adapters, etc, manufactured by Hakko Medical (Japan)
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Eligibility Criteria
Age Range30 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: 1. Subjects completing 12 weeks treatment in Study M12-921 who would benefit from long-term treatment from ABT-SLV187. Alternatively, subjects who (i) participated in the Phase 2 Study M12-925 (ii) would, in the opinion of the Investigator, benefit from ABT-SLV187 treatment in t...

Countries:JapanSouth KoreaTaiwan
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