A Clinical Evaluation Of The Safety Of Baclofen Er Capsules (Grs) When Administered Once Daily To Subjects With Spasticity Due To Multiple Sclerosis (Ms): An Open Label, Long Term, Safety Trial
This is a multicenter, open-label, safety trial in subjects with spasticity due to MS. Approximately 200 subjects will be enrolled in approximately 30-35 centers, in order to obtain safety data from at least 100 subjects who have completed at least 26 weeks of treatment. An attempt will be made to enroll at least 20 subjects who will be baclofen-naïve at entry.
Subjects enrolled in clinical trial CLR_09_21 who complete the double-blind randomized withdrawal phase (Part 3) of that trial will be eligible to participate in this trial. In addition, subjects not enrolled in trial CLR_09_21 who are on a stable daily dose (same total daily dose of baclofen for at least 30 days prior to enrollment) of baclofen immediate release (IR), as well as baclofen-naïve subjects will be eligible to participate in this trial.
Subjects enrolled in this trial who did not participate in CRL_09_21 will receive open label Baclofen ER Capsules (GRS). Subjects who enroll in this trial and participated in the double-blind phase of study CRL_09_21 will temporarily receive blinded study medication during the first 4 weeks which will be dispensed using an electronic drug-dispensing system (IVRS/IWRS).
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A CLINICAL EVALUATION OF THE SAFETY OF BACLOFEN ER CAPSULES (GRS) WHEN ADMINISTERED ONCE DAILY TO SUBJECTS WITH SPASTICITY DUE TO MULTIPLE SCLEROSIS (MS): AN OPEN LABEL, LONG TERM, SAFETY TRIAL|
- No. of participants with adverse events [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
- No. of participants with adverse vital signs [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
- Number of participants with adverse laboratory parameters [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: Baclofen ER
The subjects will receive Baclofen capsules
Subjects enrolled following the completion of protocol CLR_09_21 will receive daily doses of Baclofen ER Capsules (GRS) as follows:
Subjects enrolled in this study who participated in the double-blind phase of study CLR_09_21 will temporarily receive blinded study medication in the first 4 weeks dispensed according to the IVRS/IWRS.
All subjects will undergo safety assessments at Screening (Visit 1), Baseline (Visit 2), Week 4 (Visit 3), Week 12 (Visit 4), Week 26 (Visit 5) and all follow-up visits conducted every three months
Please refer to this study by its ClinicalTrials.gov identifier: NCT01797185
|Contact: Shravanti Bhowmik, MD||+91 22 66455645 ext firstname.lastname@example.org|
|Contact: Brian Petersoon, MD|
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|Study Director:||Shravanti Bhowmik, MD||Sun Pharma Advanced Research Company Ltd, India|