ABT-SLV187
DrugDose levels will be individually optimized
NCT Number: NCT02082249
This is an extension study to evaluate the long-term safety and tolerability of ABT-SLV187 in subjects with advanced Parkinson's disease.
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Notify Me30 year–99 year
All sexes
Interventional
Phase 3
National Hospital Organization Asahikawa Medical Center /ID# 101178, Asahikawa, Hokkaido, Japan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dose levels will be individually optimized
Time frame: 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.
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.
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.
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.
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.
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.
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."
AbbVie
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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