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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-SLV187 | Experimental | up to 6 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-SLV187 | Drug | Dose levels will be individually optimized |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Hospital Organization Asahikawa Medical Center /ID# 101178 | Asahikawa | Hokkaido | 070-8644 | Japan | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29511383 | Derived | Murata M, Mihara M, Hasegawa K, Jeon B, Tsai CH, Nishikawa N, Oeda T, Yokoyama M, Robieson WZ, Chatamra K, Facheris MF, Benesh J. Safety and efficacy of levodopa-carbidopa intestinal gel: results from an open-label extension study in Japanese, Korean and Taiwanese patients with advanced Parkinson's disease. Ther Adv Neurol Disord. 2018 Feb 26;11:1756286418759315. doi: 10.1177/1756286418759315. eCollection 2018. |
| Label | URL |
|---|---|
| clinical study report synopsis | View source |
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AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
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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 |
| National Hospital Organization Sagamihara National Hospital /ID# 98662 |
| Sagamihara-shi |
| Kanagawa |
| 252-0315 |
| Japan |
| Osaka University Hospital /ID# 108335 | Suita-shi | Osaka | 565-0871 | Japan |
| National Center of Neurology and Psychiatry /ID# 98664 | Kodaira | Tokyo | 187-8551 | Japan |
| Kyoto University Hospital /ID# 112136 | Sakyo-ku | 606-8507 | Japan |
| Seoul National University Hospital /ID# 105935 | Seoul | 03080 | South Korea |
| Linkou Chang Gung Memorial Ho /ID# 102297 | Taoyuan City | 33305 | Taiwan |