Espasticidad en Ictus - Estudio AleatorizadoEstudio aleatorizado, controlado, abierto, de grupos paralelos, multicéntrico, para comparar el efecto de la Terapia con Baclofeno Intratecal (ITB Therapy®) con el Mejor Tratamiento Médico (MTM) en pacientes con espasticidad grave post-ictus después de seis meses de tratamiento activo - SISTERS

Phase 1

Conditions: espasticidad post-ictus
MedDRA version: 9Level: PTClassification code 10028335Term: Muscle spasticity

Registration Number: EUCTR2009-011216-38-ES

Lead Sponsor: Medtronic International trading

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.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