MedTrace Logo

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

NCT00752934 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-12-31

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy

Interventions

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.

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

Sponsors & Collaborators

  • Shaare Zedek Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00752934 on ClinicalTrials.gov