This is an extension study to evaluate the long-term safety and tolerability of ABT-SLV187 in subjects with advanced Parkinson's disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Dose levels will be individually optimized
National Hospital Organization Asahikawa Medical Center /ID# 101178
Asahikawa, Hokkaido, Japan
National Hospital Organization Sagamihara National Hospital /ID# 98662
Sagamihara-shi, Kanagawa, Japan
Osaka University Hospital /ID# 108335
Suita-shi, Osaka, Japan
National Center of Neurology and Psychiatry /ID# 98664
Number of Participants with Adverse Events
All negative changes in health during the study will be treated and recorded during the study.
Time frame: From Day 1 up to 6 years (estimated maximum)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Kodaira, Tokyo, Japan
Kyoto University Hospital /ID# 112136
Sakyo-ku, Japan
Seoul National University Hospital /ID# 105935
Seoul, South Korea
Linkou Chang Gung Memorial Ho /ID# 102297
Taoyuan City, Taiwan
Time frame: 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."
Time frame: From Screening Visit 2 of M12-921 to Week 52 of M12-923