SISTERS: Spasticity In Stroke Study - Randomized Study
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Ashworth scale [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
- To evaluate safety by evaluating Adverse Event occurence. [ Time Frame: Baseline, 3 months, 6 months and every other visits ] [ Designated as safety issue: Yes ]
- To evaluate the differences between ITB Therapy and BMT [ Time Frame: Baseline, 3 months, 6 months and every other visits ] [ Designated as safety issue: No ]
The differences between ITB Therapy and BMT are evaluated through:
- Spasticity in the upper extremities assessed by AS
- Function assessed by Functional Independence Measure
- Function assessed by 10 meter timed walking test
- Function assessed by ability to transfer
- Pain assessed by Numeric Pain Rating Scale (NPRS)
- Primary therapy goal achievement assessed by Goal Attainment Scale (GAS)
- Quality of Life (QoL) assessed by EuroQol group-5 Dimensional (EQ-5D)
- QoL assessed by the SF-12
- QoL assessed by the Stroke Specific -Quality of Life (SS-QoL)
- Satisfaction with the therapy assessed by Likert Scale
- Healthcare resource utilization
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Active Comparator: ITB therapy
Intrathecal Baclofen therapy (Intrathecal baclofen + implantable pump)
Drug: intrathecal baclofen
ITB test, implant, 6 months follow-up
No Intervention: Best Medical Treatment (BMT)
Use one or a combination oral antispastic medication.
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:
- ITB Therapy arm; or
- 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032239
|Contact: Nathalie Berthuy||+41 firstname.lastname@example.org|
|Contact: Alessandra Calabrese||+41 21 803 email@example.com|
Show 26 Study Locations
|Principal Investigator:||Leopold SALTUARI, Prof.||Landeskrankenhaus Hochzirl, Zirl (Austria)|