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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02082249|
Recruitment Status : Active, not recruiting
First Posted : March 10, 2014
Last Update Posted : November 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Advanced Parkinson's Disease||Drug: ABT-SLV187||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||March 10, 2014|
|Estimated Primary Completion Date :||December 27, 2023|
|Estimated Study Completion Date :||December 27, 2023|
up to 9 years
Dose levels will be individually optimized
- Number of Participants with Adverse Events [ Time Frame: From Day 1 up to 9 years (estimated maximum) ]All negative changes in health during the study will be treated and recorded during the study.
- Change in Patient Global Impression of Change (PGIC) scores [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 © [ Time Frame: 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 [ Time Frame: 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."
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082249
|National Hospital Organization Asahikawa Medical Center /ID# 101178|
|Asahikawa, Hokkaido, Japan, 070-8644|
|National Hospital Organization Sagamihara National Hospital /ID# 98662|
|Sagamihara-shi, Kanagawa, Japan, 252-0315|
|Osaka University Hospital /ID# 108335|
|Suita-shi, Osaka, Japan, 565-0871|
|National Center of Neurology and Psychiatry /ID# 98664|
|Kodaira, Tokyo, Japan, 187-8551|
|Kyoto University Hospital /ID# 112136|
|Sakyo-ku, Japan, 606-8507|
|Korea, Republic of|
|Seoul National University Hospital /ID# 105935|
|Seoul, Korea, Republic of, 03080|
|Linkou Chang Gung Memorial Ho /ID# 102297|
|Taoyuan City, Taiwan, 33305|
|Study Director:||AbbVie Inc.||AbbVie|