Spasticity in Stroke - Randomized Study A multi-center study comparing the effect of two treatments for spasticity in which patients are randomly assigned to one of the following treatment groups: 1) Intrathecal Baclofen Therapy (ITB Therapy®) a therapy for spasticity whereby the drug, Lioresal Intrathecal, is delivered near the spine through an implantable drug infusion system 2) Best Medical Treatment (BMT) includes oral medications for spasticity

Phase 1

• Conditions: Post-stroke spasticity; MedDRA version: 17.0 Level: PT Classification code 10028335 Term: Muscle spasticity System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-19
• Study Completion: 2016-09-21
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

To be eligible for inclusion into this study, patients must fulfil all of the following criteria prior to study enrolment:

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. Patieint experienced last stroke > 6 months prior to enrolment

4. Patient presents spasticity in at least two extremities

5. Patient presents an Ashworth score of at least 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 the last month
NOTE: ventriculo-peritoneal shunts and valves can be present

8. If female, she must either:
a. be post-menopausal or surgically sterilised; 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 the 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 58
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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 anatagonists e.g. 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 injectin less than 4 months ago

9. According to the investigator's opinion, the patient is not capable to comprehend the nature of the study and to give his/her informed consent him/herself

Study & Design

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