Spasticity in Stroke – Randomized StudyA randomized, controlled, open-label, parallel-group, multi-center study to compare the effect of Intrathecal Baclofen Therapy (ITB Therapy®) versus Best Medical Treatment (BMT) on spasticity in post-stroke patients after 6 months active treatment - SISTERS

Phase 1

• Conditions: Post-stroke spasticity

• Registration Number: EUCTR2009-011216-38-NL
• Lead Sponsor: Medtronic International trading

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-11
• Last Update Posted: 9 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 affected muscle groups in the lower extremities
6.patient is eligible to receive ITB Therapy following the Adult Spasticity Algorithm
a.Patient does not reach his/her therapy goal with other treatment interventions
7.patient is medically stable:
a.stable blood pressure:
i.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, eg warfarin or coumadin; unless the patient can switch to another accepted anticoagulant (e.g. heparin) 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