Does Oral Baclofen Improve Care and Comfort in Spastic Children in Nursing Homes?
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cerebral Palsy |
Drug: oral baclofen + placebo Drug: placebo + oral baclofen |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
- care and comport questionnaires [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 1 Year to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Cerebral palsy nursing homes children ages 1-18 years spastic quadriplegia
Exclusion Criteria:
- active epilepsy severe truncal hypotonia
Contacts and Locations| Israel | |
| Saare Zedek Medical Center | Recruiting |
| Jerusalem, Israel | |
| Contact: Hilla Ben Pazi, MD Benpazi@gmail.com | |
More Information
No publications provided
| Responsible Party: | Hilla Ben Pazi, MD, Shaare Zedek Medical Center |
| ClinicalTrials.gov Identifier: | NCT00752934 History of Changes |
| Other Study ID Numbers: | 59/08 |
| Study First Received: | September 15, 2008 |
| Last Updated: | April 17, 2011 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Shaare Zedek Medical Center:
|
nursing homes children ages 1-18 years spastic quadriplegia |
Additional relevant MeSH terms:
|
Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases Baclofen GABA-B Receptor Agonists GABA Agonists GABA Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Muscle Relaxants, Central Neuromuscular Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013