A Multicenter, Open-Label Randomized Crossover Trial to Assess Subject Preference for Kemstro™ Compared to Conventional Baclofen Tablets in Subjects With Stable Multiple Sclerosis
Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis
Intervention: Kemstro (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: UCB Official(s) and/or principal investigator(s):
Patricia Witt, Study Director, Affiliation: UCB
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.
Clinical Details
Official title: A Multicenter, Open-Label Randomized Crossover Trial to Assess Subject Preference for Kemstro™ Compared to Conventional Baclofen Tablets in Subjects With Stable Multiple Sclerosis
Study design: Randomized, Open Label, Dose Comparison, Crossover Assignment
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- stable dose of baclofen
Exclusion Criteria:
- not stable dosing
Locations and Contacts
Schwarz, Milwaukee, Wisconsin, United States
Additional Information
Starting date: January 2005
Ending date: April 2005
Last updated: April 16, 2008
|
