Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00139789
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00139789
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : August 30, 2013
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Kemstro Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2005
Actual Primary Completion Date : April 2005
Actual Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Baclofen





Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • stable dose of baclofen

Exclusion Criteria:

  • not stable dosing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139789


Locations
Layout table for location information
United States, Wisconsin
Schwarz
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
UCB Pharma
Investigators
Layout table for investigator information
Study Director: UCB Clinical Trial Call Center UCB Pharma

Additional Information:
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00139789    
Other Study ID Numbers: SP843
First Posted: August 31, 2005    Key Record Dates
Last Update Posted: August 30, 2013
Last Verified: September 2009
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Baclofen
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action