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

Study Overview
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Brief Summary
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This is an extension study to evaluate the long-term safety and tolerability of ABT-SLV187 in subjects with advanced Parkinson's disease.

Official Title
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An Open-Label Three-Part Extension Study Assessing 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

Conditions
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Advanced Parkinson's Disease

Intervention / Treatment
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* Drug: ABT-SLV187


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 the Study M12-923, (iii) did not discontinue the M12-925 Study due to safety reason, and (iv) meet all entry requirements. Lastly, subjects who completed another ABT-SLV187 study (e.g., Study M12-927) in South Korea. The subject must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study procedures (including any changes occurring in the subject's current therapeutic regimen). The subject must be willing to continue on treatment. Exclusion Criteria: Subject is enrolled in another clinical trial. Psychiatric, neurological or behavioral disorders that may interfere with the ability of subjects to give informed consent, or interfere with the conduct of the study. Medical, laboratory, or surgical issues deemed by the Investigator to be clinically significant and in the opinion of the PI, would be a contraindication to continued levodopa therapy. Uncooperative attitude or reasonable likelihood for non-compliance with the protocol. Subject has current significant suicidal ideation as evidenced by answering yes to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale completed at the Week 12 Visit of Study M12-921 or at the Baseline Visit of the current study for M12-925 or M12-927 study subjects. Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to continue to receive ABT-SLV187.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABT-SLV187<br>up to 6 years | Drug: ABT-SLV187<br>* Dose levels will be individually optimized<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events | All negative changes in health during the study will be treated and recorded during the study. | From Day 1 up to 6 years (estimated maximum) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Global Impression of Change (PGIC) scores | The PGIC is a 7-point response scale. The subject will be asked by the Investigator or qualified designee to rate their change in their disease status. | From Screening Visit 2 of M12-921 to Week 52 of M12-923 | 
| Change in the Unified Parkinson's Disease Rating Scale (UPDRS) score | The Unified Parkinson's Disease Rating Scale (UPDRS) is an Investigator-used rating tool to follow the course of Parkinson's disease. | From Day 1 up to 36 months (estimated maximum) | 
| Change in the Parkinson's Disease Questionnaire-39 (PDQ-39) scores | The PDQ-39 is a disease-specific instrument designed to measure aspects of health that are relevant to subjects with PD, and which may not be included in general health status questionnaires. | From Screening Visit 2 of M12-921 to Week 52 | 
| Change in PD Diary mean daily On time without troublesome dyskinesia (On time without dyskinesia or with non-troublesome dyskinesia) or On time with troublesome dyskinesia | The study will assess the difference in the amount of time a subject is able to move and function well during the day. | From Day 1 to Week 52 | 
| Change in the mean daily Off time (hours) as measured by the Parkinson's Disease (PD) Diary © | The study will assess the difference in the amount of time a subject is unable to move and function during the day. | From Day 1 to Week 52 | 
| Change in Clinical Global Impression of Change (CGI-C) scores | The 7-item CGI-C (Change) scale assesses the overall degree of illness relative to Week 0. A rating of 4 is equivalent to no change. Ratings < 4 are equivalent to improvement and ratings of 4 are equivalent to worsening. | From Screening Visit 2 of M12-921 to Week 52 of M12-923 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Efficacy, Safety, Tolerability, levodopa-carbidopa intestinal gel, levodopa, carbidopa, Advanced Parkinson's Disease