| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02082249 | An 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 Medications | PHASE3 | COMPLETED | 30 | — | — | Mar 10, 2014 | Oct 31, 2019 | May 12, 2021 | 7 | Japan, South Korea +1 |
| NCT01479127 | Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease | PHASE2 | COMPLETED | 8 | — | — | Oct 1, 2011 | Jul 1, 2012 | Apr 21, 2016 | - | — |
All negative changes in health during the study will be treated and recorded during the study.
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.
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.
M=male, F=female, MCV=mean corpuscular volume, MCH=mean corpuscular hemoglobin, MCHC=mean corpuscular hemoglobin concentration.
M=male, F=female, γ-GTP=gamma-glutamyl transpeptidase.
M=male, F=female
↓=decrease, ↑=increase, BL=baseline, temp.=temperature, SBP=systolic blood pressure, Sup.=supine, Sta.=standing, DBP=diastolic blood pressure.
High potentially clinically significant Bazett's heart rate-corrected QT interval (QTcB) values were: 450 msec for males / 470 msec for females.
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).
| Arm | Type | Description |
|---|---|---|
| ABT-SLV187 | EXPERIMENTAL | up to 6 years |
| Levodopa-carbidopa intestinal gel | EXPERIMENTAL | Following 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. |
| Name | Type | Description |
|---|---|---|
| ABT-SLV187 | DRUG | Dose levels will be individually optimized |
| Oral Levodopa/Carbidopa | DRUG | Tablet; contains 100 mg levodopa and 10 mg carbidopa |
| Infusion Pump: CADD-Legacy® 1400 Pump | DEVICE | General infusion pump, manufactured by Smiths Medical (US) |
| NJ-Tube: Silicon ED Tube | DEVICE | Device used to deliver nutrition/drug to stomach/intestine or to aspirate stomach fluid, manufactured by Create Medic Co., Ltd. (Japan) |
| Adaptor: Hakko Adaptor | DEVICE | Accessory set for fluid infusion set, consisting of caps, connectors and adapters, etc, manufactured by Hakko Medical (Japan) |
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...