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
Overview
- Phase
- Phase 4
- Intervention
- intrathecal baclofen
- Conditions
- Severe Spasticity
- Sponsor
- MedtronicNeuro
- Enrollment
- 61
- Locations
- 25
- Primary Endpoint
- Change in Average Ashworth Scale (AS) in Affected Lower Extremities From Baseline to Month 6
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief 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.
Detailed Description
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ITB therapy
Intrathecal Baclofen therapy (Intrathecal baclofen + implantable pump)
Intervention: intrathecal baclofen
Outcomes
Primary Outcomes
Change in Average Ashworth Scale (AS) in Affected Lower Extremities From Baseline to Month 6
Time Frame: Baseline and month 6
AS is a manual test, measuring the resistance to passive movement about a joint with varying degrees of velocity. Scores range from 1-5, with 5 choices. A score of 1 indicates no resistance, and 5 indicates rigidity. The following muscle groups in the lower extremities were assessed: hip flexors, hip adductors, knee extensors, knee flexors, plantar flexors and ankle-dorsal flexors. Average AS was calculated as the average of AS scores of the 6 muscles of the affected lower extremity. Change in average AS in affected lower extremities from baseline to month 6 between ITB and BMT arm was assessed. Change= AS at month 6 - AS at baseline.
Secondary Outcomes
- Change in Numeric Pain Rating Scale (NPRS) From Baseline to Month 6(Baseline and month 6)
- Number of Participants Who Achieved Their Primary Therapeutic Goal Assessed With the Goal Attainment Scale (GAS)(month 6)
- Change in Average 10 Meter Time Walking Test (10MTWT) From Baseline to Month 6(Baseline and month 6)
- Change in Euro QoL Group-5 Dimensional, 3 Level Version (EQ-5D-3L) From Baseline to Month 6(Baseline and month 6)
- Change in SF-12 (12-item Short Form) From Baseline to Month 6(Baseline and month 6)
- Therapy Satisfaction(month 6)
- Number of Participants Who Were Able to Transfer From the Wheelchair to Bed Without Human Assistance(baseline, month 3, month 6)
- Change in Average Ashworth Scale (AS) in Affected Upper Extremities From Baseline to Month 6(Baseline and month 6)
- Change in Stroke Specific Quality of Life (SS-QoL ) From Baseline to Month 6(Baseline and month 6)
- Change in Functional Independence Measure (FIM) Score From Baseline to Month 6(Baseline and month 6)
- Healthcare Resource Utilization(baseline, ITB test (only ITB arm), second assessment (only BMT arm), week 6 (only ITB arm), month 3, month 6)