A randomized, controlled, open-label, parallel-group, multicenter study to compare the effect of Intrathecal Baclofen Therapy (ITB Therapy) versus Best Medical Treatment (BMT) on severe spasticity in post-stroke patients after 6 months active treatment - SISTERS

Phase 1

• Conditions: Post-stroke spasticity

• Registration Number: EUCTR2009-011216-38-BE
• Lead Sponsor: Medtronic International Trading Sarl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-15
• Last Update Posted: 23 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

To be eligible for inclusion into this study, patients must fulfill all of the following criteria prior to study enrollment:
1. patient (or legal guardian) has been informed of the study procedures and has given written informed consent
2. 18-75 years of age
3. patient experienced last stroke > 6 months prior to enrollment
4. patient presents spasticity in at least 2 extremities
5. patient presents an Ashworth score = 3 in a minimum of two of the af-fected muscle groups in the lower extremities
6. patient is eligible to receive ITB Therapy following the Adult Spasticity Al-gorithm
a. patient does not reach his/her therapy goal with other treatment in-terventions
7. stable blood pressure:
a. no change in hypertensive medication in last month (NOTE: ventriculo-peritoneal shunts and valves can be present)
8. if female, she must either
a. be post-menopausal or surgically sterilized; or
b. use a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study
9. patient/family is willing to comply with study protocol including attending the study visits

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

To be eligible for inclusion in this study the patients must not meet any of the following criteria:
1. patient/family is considered by the physician to be unable or unwilling to participate in long-term ITB Therapy management
2. patient has known hypersensitivity to baclofen
3. active systemic infection (NOTE: pressure sores are not a contraindication unless they are present near the implant sites)
4. presence of a cardiac pacemaker, ICD, implantable neurostimulator or drug delivery device
5. uncontrolled refractory epilepsy
6. use of oral vitamin K antagonists, e.g. warfarin/coumadin; unless the pa-tient can switch to another accepted anticoagulant (e.g. heparin, aggre-nox, fragmin, plavix, ticlid) for the period of ITB test and implant
7. patient is pregnant or breast-feeding
8. patient received a Botulinum toxin injection less than 4 months ago

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified