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NCT00139789 Clinical Trial

A Multicenter, Open-label Randomized Crossover Trial to Assess Subject Preference for Kemstro™ Compared to Conventional Baclofen Tablets in Subjects With Stable Multiple Sclerosis

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00139789
Other study ID # SP843
Secondary ID
Status Completed
Phase Phase 3
First received August 29, 2005
Last updated August 29, 2013
Start date January 2005
Est. completion date April 2005

Study information
Verified date September 2009
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date April 2005
Est. primary completion date April 2005
Accepts healthy volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- stable dose of baclofen

Exclusion Criteria:

- not stable dosing

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Kemstro

Locations
Country Name City State
United States Schwarz Milwaukee Wisconsin

Sponsors (1)
Lead Sponsor Collaborator
UCB Pharma

Country where clinical trial is conducted

United States, 

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