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

NCT ID: NCT00752934

Last Updated: 2018-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebral Palsy

Keywords

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nursing homes children ages 1-18 years spastic quadriplegia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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group a

Baclofen followed by Placebo

Group Type EXPERIMENTAL

oral baclofen + placebo

Intervention Type DRUG

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.

group b

Placebo followed by Baclofen

Group Type EXPERIMENTAL

placebo + oral baclofen

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* active epilepsy severe truncal hypotonia
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Dr. Hilla Ben-Pazi

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Saare Zedek Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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59/08

Identifier Type: -

Identifier Source: org_study_id