drugset / Trial / NCT00139789

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

NCT00139789

Phase 3 Completed 60 enrolled UCB Pharma
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2005-01
Primary completion
2005-04
Completion
2005-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Baclofen Small molecule

Indications