Cerebral Palsy | Does Oral Baclofen Improve Care and Comfort in Spastic Children in Nursing Homes?
Cerebral Palsy research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - Cerebral palsy nursing homes children ages 1-18 years spastic quadriplegia Exclusion Criteria: - active epilepsy severe truncal hypotonia
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:oral baclofen + placeboGroup A will be given 13 weeks of oral baclofen followed by a 2-week non-treatment (washout) period, and then 13 weeks of oral placebo. For participants who with weight under 15 Kg at the time of enrolment, the initial oral baclofen dose will be 2.5 mg daily, increasing weekly over a 7-week period to 10 mg three times a day, and will be continued at that dose for the following 5 weeks. For those participants who will be over 15 Kg at the time of enrollment, the starting oral baclofen dose will be 5 mg daily, increasing over a 9-week period to 20 mg three times a day, and will be continued for the next 3 weeks at that dose. At the end of each 12-week period, the drug (either baclofen or placebo) will be tapered over 6 days. Children's carers will given information on possible side effects, and asked to contact one of the researchers if any adverse events occur.
Drug:placebo + oral baclofenGroup B will receive 13 weeks of oral placebo followed by 2-week nontreatment, and then 13 weeks of oral baclofen
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
group aBaclofen followed by Placebo
group bPlacebo followed by Baclofen
Start Date: October 2010
Completed Date: June 2015
Phase: Phase 4
Primary Outcome: care and comport questionnaires
Study sponsors, principal investigator, and references
Lead Sponsor: Shaare Zedek Medical Center