Severe Spasticity Clinical Trial
Official title:
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
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.
This is a randomized, controlled open-label parallel group study to demonstrate the efficacy
benefit of ITB Therapy over BMT in post-stroke patients with severe spasticity who have not
reached their therapy goal with other treatment interventions.
In order to evaluate the efficacy benefit of ITB Therapy over BMT in post-stroke patients, a
two-arm parallel group design will be applied. Patients will be equally randomized to one of
two treatment arms:
1. ITB Therapy arm; or
2. BMT arm
The study consists of a run-in phase of 21 days for the BMT treatment arm and 2-25 days for
the ITB Therapy treatment arm, followed by a 6 month active trial.
The BMT treatment arm will receive a combination of oral antispastic medication and
physiotherapy. Patients must be prescribed at least one or a combination of the following
oral antispastic medications: oral baclofen, tizanidine, diazepam (or other benzodiazepines)
or dantrolene. Following the run-in phase, patients will enter the 6 month active trial.
The ITB Therapy treatment arm will receive a combination of ITB Therapy and physiotherapy.
During the run-in phase, a test with intrathecal baclofen will be performed to evaluate the
response of the patient. Patients fulfilling the test success criterium will be implanted
with a Medtronic SynchroMed®II infusion system. Following implant, patients will enter into
the 6 month active trial, which includes a 6 week titration phase, during which time oral
antispastic medications must be gradually reduced with complete discontinuation by the end of
the titration period.
During the 6 month active trial, patients will be assessed at 3 and 6 months. All primary and
secondary endpoint assessments will be performed by a blinded assessor.
The total study duration is expected to be 60 months, including a 39 month enrollment period.
The total duration per patient is approximately 7 months (approximately 1 month run-in period
followed by 6 months active treatment).
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00773019 -
SynchroMed II Post-Approval Study
|
||
| Completed |
NCT01520545 -
Safety Study of 3 mg/mL Baclofen Injection (Intrathecal) Using A Programmable Pump
|
Phase 3 |