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: Spasticity in Stroke - Randomized Study (Spasticita` nell`ictus - studio randomizzato)

Phase 1

Conditions: adult post-stroke patients with generalized spastic hypertonia
MedDRA version: 9.1Level: SOCClassification code 10029205

Registration Number: EUCTR2009-011216-38-IT

Lead Sponsor: MEDTRONIC

Brief Summary: Not available

Detailed Description: Not available

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. 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 patient can switch to another accepted anticoagulant (e.g. heparin, aggrenox, 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