Does Oral Baclofen Improve Care and Comfort in Spastic Children in Nursing Homes?

Cerebral Palsy Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00752934
• Other study ID #: 59/08
• Status: Terminated
• Phase: Phase 4
• Start date: October 2010
• Est. completion date: June 2015

Study information

• Verified date: December 2018
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

• Cerebral palsy nursing homes children ages 1-18 years spastic quadriplegia

Exclusion Criteria:

• active epilepsy severe truncal hypotonia

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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.
• placebo + oral baclofen
Group B will receive 13 weeks of oral placebo followed by 2-week nontreatment, and then 13 weeks of oral baclofen

Locations

Country	Name	City	State
Israel	Saare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	care and comport questionnaires		28 weeks