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: September 14, 2009 History of Changes

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
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

Study Type:	Interventional
Study Design:	Treatment, 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

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Baclofen

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Enrollment:	60
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, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

UCB, Inc.

More Information

Additional Information:

Study Summary on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	SP843
Study First Received:	August 29, 2005
Last Updated:	September 14, 2009
ClinicalTrials.gov Identifier:	NCT00139789 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Neurotransmitter Agents
Autoimmune Diseases
Molecular Mechanisms of Pharmacological Action
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Baclofen
Physiological Effects of Drugs
Neuromuscular Agents
Sclerosis
Pharmacologic Actions

Multiple Sclerosis
Pathologic Processes
GABA Agonists
Therapeutic Uses
Muscle Relaxants, Central
GABA Agents
Demyelinating Autoimmune Diseases, CNS
Peripheral Nervous System Agents
Central Nervous System Agents
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on November 27, 2009