At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 61 enrolled
Drug / intervention
intrathecal baclofendrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Controlled, Open-label, Parallel-group, Multi-center Study to Compare the Effect of Intrathecal Baclofen Therapy Versus Best Medical Treatment on Severe Spasticity in Post-stroke Patients After 6 Months Active Treatment
In Brief
A Phase 4 clinical trial evaluating intrathecal baclofen for Severe Spasticity. Completed, enrolled 61 participants across 25 sites in 9 countries.
Detailed Summary
To demonstrate that Intrathecal Baclofen (ITB) Therapy, compared to Best Medical Treatment (BMT), has superior efficacy in the treatment of severe spasticity in adult post-stroke patients with generalized spastic hypertonia who have not reached their therapy goal with other treatment interventions assessed by a decrease in the average Ashworth Scale (AS) score in the lower extremities.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Spasticity
CountriesAustria, Belgium, Germany, Italy, Netherlands, Slovenia, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2009
First PostedDec 2009
Primary CompletionSep 2016
TodayJul 2026
First PostedDec 15, 2009
Enrollment StartNov 1, 2009
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 16.5 years ago
Interventions
intrathecal baclofendrug
ITB test, implant, 6 months follow-up