Does Oral Baclofen Improve Care and Comfort in Spastic Children in Nursing Homes?
Information source: Shaare Zedek Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cerebral Palsy
Intervention: oral baclofen + placebo (Drug); placebo + oral baclofen (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Shaare Zedek Medical Center
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.
Clinical Details
Study design: Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: care and comport questionnaires
Eligibility
Minimum age: 1 Year.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Cerebral palsy nursing homes children ages 1-18 years spastic quadriplegia
Exclusion Criteria:
- active epilepsy severe truncal hypotonia
Locations and Contacts
Additional Information
Starting date: October 2009
Ending date: September 2010
Last updated: September 15, 2008
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