Abstract | OBJECTIVE: METHODS: This multicenter, randomized, double-blind, placebo-controlled trial was performed at 2 university medical centers in the Netherlands. Patients with severe dyskinetic cerebral palsy (Gross Motor Functioning Classification System level IV-V) aged 4 to 24 years who were eligible for intrathecal baclofen were included. Patients were assigned by block randomization (2:2) for treatment with intrathecal baclofen or placebo for 3 months via an implanted microinfusion pump. The primary outcome was goal attainment scaling of individual treatment goals (GAS T score). A linear regression model was used for statistical analysis with study site as a covariate. Safety analyses were done for number and type of (serious) adverse events. RESULTS: Thirty-six patients were recruited from January 1, 2013, to March 31, 2018. Data for final analysis were available for 17 patients in the intrathecal baclofen group and 16 in the placebo group. Mean (standard deviation) GAS T score at 3 months was 38.9 (13.2) for intrathecal baclofen and 21.0 (4.6) for placebo (regression coefficient = 17.8, 95% confidence interval = 10.4-25.0, p < 0.001). Number and types of (serious) adverse events were similar between groups. INTERPRETATION:
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Authors | Laura A Bonouvrié, Jules G Becher, Johan S H Vles, R Jeroen Vermeulen, Annemieke I Buizer, IDYS Study Group |
Journal | Annals of neurology
(Ann Neurol)
Vol. 86
Issue 1
Pg. 79-90
(07 2019)
ISSN: 1531-8249 [Electronic] United States |
PMID | 31050023
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2019 The Authors. Annals of Neurology published by Wiley Periodicals, Inc. on behalf of American Neurological Association. |
Chemical References |
- Muscle Relaxants, Central
- Baclofen
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Topics |
- Adolescent
- Adult
- Baclofen
(administration & dosage)
- Cerebral Palsy
(diagnosis, drug therapy)
- Child
- Child, Preschool
- Double-Blind Method
- Female
- Humans
- Injections, Spinal
- Male
- Muscle Relaxants, Central
(administration & dosage)
- Treatment Outcome
- Young Adult
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