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

Sponsor

AbbVie (Industry)

Overall Status

Completed

CT.gov ID

NCT02082249

Collaborator

(none)

Enrollment

Locations

Arm

67.7

Actual Duration (Months)

4.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Advanced Parkinson's Disease	Drug: ABT-SLV187	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 10, 2014

Actual Primary Completion Date :

Oct 31, 2019

Actual Study Completion Date :

Oct 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ABT-SLV187 up to 6 years	Drug: ABT-SLV187 Dose levels will be individually optimized

Arm

Intervention/Treatment

Experimental: ABT-SLV187

up to 6 years

Drug: ABT-SLV187

Dose levels will be individually optimized

Outcome Measures

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Patient Global Impression of Change (PGIC) scores [From Screening Visit 2 of M12-921 to Week 52 of M12-923]
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.
Change in the Unified Parkinson's Disease Rating Scale (UPDRS) score [From Day 1 up to 36 months (estimated maximum)]
The Unified Parkinson's Disease Rating Scale (UPDRS) is an Investigator-used rating tool to follow the course of Parkinson's disease.
Change in the Parkinson's Disease Questionnaire-39 (PDQ-39) scores [From Screening Visit 2 of M12-921 to Week 52]
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.
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 [From Day 1 to Week 52]
The study will assess the difference in the amount of time a subject is able to move and function well during the day.
Change in the mean daily "Off" time (hours) as measured by the Parkinson's Disease (PD) Diary © [From Day 1 to Week 52]
The study will assess the difference in the amount of time a subject is unable to move and function during the day.
Change in Clinical Global Impression of Change (CGI-C) scores [From Screening Visit 2 of M12-921 to Week 52 of M12-923]
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."

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Hospital Organization Asahikawa Medical Center /ID# 101178	Asahikawa	Hokkaido	Japan	070-8644
2	National Hospital Organization Sagamihara National Hospital /ID# 98662	Sagamihara-shi	Kanagawa	Japan	252-0315
3	Osaka University Hospital /ID# 108335	Suita-shi	Osaka	Japan	565-0871
4	National Center of Neurology and Psychiatry /ID# 98664	Kodaira	Tokyo	Japan	187-8551
5	Kyoto University Hospital /ID# 112136	Sakyo-ku		Japan	606-8507
6	Seoul National University Hospital /ID# 105935	Seoul		Korea, Republic of	03080
7	Linkou Chang Gung Memorial Ho /ID# 102297	Taoyuan City		Taiwan	33305