Does Oral Baclofen Improve Care and Comfort in Spastic Children in Nursing Homes?

Phase 4

Terminated

• Conditions: Cerebral Palsy
• Interventions: Drug: oral baclofen + placebo; Drug: placebo + oral baclofen

• Registration Number: NCT00752934
• Lead Sponsor: Shaare Zedek Medical Center

Brief Summary

Baclofen is a drug that reduces the muscle stiffness. In disabled children that have very stiff muscles, the stiffness and secondary changes in the joints may cause discomfort and pain. In this study we will check if treatment with Baclofen reduces pain in disabled children with stiff muscles.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-15
• Study First Submitted QC: 2008-09-15
• Study First Posted: 2008-09-16
• Study Start: 2010-10
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-27
• Last Update Posted: 2018-12-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Cerebral palsy nursing homes children ages 1-18 years spastic quadriplegia

Exclusion Criteria

• active epilepsy severe truncal hypotonia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
group a	oral baclofen + placebo	Baclofen followed by Placebo
group b	placebo + oral baclofen	Placebo followed by Baclofen

Primary Outcome Measures

Name	Time	Method
care and comport questionnaires	28 weeks

Trial Locations

Locations (1)

Saare Zedek Medical Center; 🇮🇱 Jerusalem, Israel