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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00752934
Recruitment Status : Unknown
Verified September 2008 by Shaare Zedek Medical Center.
Recruitment status was:  Recruiting
First Posted : September 16, 2008
Last Update Posted : April 19, 2011
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Drug: oral baclofen + placebo Drug: placebo + oral baclofen Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Study Start Date : October 2010
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Baclofen
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. care and comport questionnaires [ Time Frame: 28 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00752934

Saare Zedek Medical Center Recruiting
Jerusalem, Israel
Contact: Hilla Ben Pazi, MD       Benpazi@gmail.com   
Sponsors and Collaborators
Shaare Zedek Medical Center
More Information

Responsible Party: Hilla Ben Pazi, MD, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00752934     History of Changes
Other Study ID Numbers: 59/08
First Posted: September 16, 2008    Key Record Dates
Last Update Posted: April 19, 2011
Last Verified: September 2008

Keywords provided by Shaare Zedek Medical Center:
nursing homes
ages 1-18 years
spastic quadriplegia

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases