A Multicenter, Open-label Randomized Crossover Trial to Assess Subject Preference for Kemstro™ Compared to Conventional Baclofen Tablets in Subjects With Stable Multiple Sclerosis
Phase 3
Completed
- Conditions
- Multiple Sclerosis
- Registration Number
- NCT00139789
- Lead Sponsor
- UCB Pharma
- Brief Summary
This was a multicenter, open-label, randomized, crossover trial in subjects with MS who were already taking a stable dose of baclofen (up to 80 mg/day) for spasticity. The trial was designed to assess subject preference for Kemstro or conventional baclofen. At Visit 1, subjects were screened, and if qualified, were randomly assigned to one of two following treatment sequences: Kemstro/conventional baclofen or conventional baclofen/Kemstro.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- stable dose of baclofen
Exclusion Criteria
- not stable dosing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of baclofen in managing spasticity in multiple sclerosis patients?
How does the pharmacokinetic profile of Kemstro compare to conventional baclofen in MS treatment?
What biomarkers predict response to baclofen-based therapies in stable multiple sclerosis cases?
What adverse events are associated with Kemstro versus standard baclofen in MS patients?
Are there combination therapies involving baclofen for spasticity in multiple sclerosis under investigation?
Trial Locations
- Locations (1)
Schwarz
🇺🇸Milwaukee, Wisconsin, United States
Schwarz🇺🇸Milwaukee, Wisconsin, United States