Does Oral Baclofen Improve Care and Comfort in Spastic Children in Nursing Homes?
Recruitment status was: Recruiting
|Cerebral Palsy||Drug: oral baclofen + placebo Drug: placebo + oral baclofen||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
- care and comport questionnaires [ Time Frame: 28 weeks ]
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||September 2012|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Experimental: group a
Baclofen followed by Placebo
Drug: oral baclofen + placebo
Group 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.
Experimental: group b
Placebo followed by Baclofen
Drug: placebo + oral baclofen
Group B will receive 13 weeks of oral placebo followed by 2-week nontreatment, and then 13 weeks of oral baclofen
Please refer to this study by its ClinicalTrials.gov identifier: NCT00752934
|Saare Zedek Medical Center||Recruiting|
|Contact: Hilla Ben Pazi, MD Benpazi@gmail.com|