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

This study has been completed.

First Received: August 29, 2005 Last Updated: April 16, 2008 History of Changes

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00139789

Purpose

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.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Kemstro	Phase III

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Baclofen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Dose Comparison, Crossover Assignment
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

Further study details as provided by UCB:

Study Start Date:	January 2005
Study Completion Date:	April 2005
Primary Completion Date:	April 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

stable dose of baclofen

Exclusion Criteria:

not stable dosing

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139789

Locations

United States, Wisconsin
Schwarz
Milwaukee, Wisconsin, United States

Sponsors and Collaborators

UCB

Investigators

Study Director:

Patricia Witt

UCB

More Information

No publications provided

Study ID Numbers:	SP843
Study First Received:	August 29, 2005
Last Updated:	April 16, 2008
ClinicalTrials.gov Identifier:	NCT00139789 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Baclofen

Demyelinating Autoimmune Diseases, CNS
Sclerosis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes
Autoimmune Diseases
Multiple Sclerosis
Immune System Diseases
Demyelinating Diseases

Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Sclerosis
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on May 07, 2009