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

Tracking Information

First Received Date ^ICMJE

August 29, 2005

Last Updated Date

September 14, 2009

Start Date ^ICMJE

January 2005

Primary Completion Date

April 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00139789 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment

Condition ^ICMJE

Multiple Sclerosis

Intervention ^ICMJE

Drug: Kemstro

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2005

Primary Completion Date

April 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

stable dose of baclofen

Exclusion Criteria:

not stable dosing

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00139789

Responsible Party

Study ID Numbers ^ICMJE

SP843

Study Sponsor ^ICMJE

UCB, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

UCB Clinical Trial Call Center

UCB, Inc.

Information Provided By

UCB, Inc.

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP