Does Oral Baclofen Improve Care and Comfort in Spastic Children in Nursing Homes? - Full Text View

Sponsor:	Shaare Zedek Medical Center
Information provided by:	Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:	NCT00752934

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 IV

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

Resource links provided by NLM:

MedlinePlus related topics: Cerebral Palsy Nursing Homes Paralysis

Drug Information available for: Baclofen

U.S. FDA Resources

Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:

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

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

active epilepsy severe truncal hypotonia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00752934

Locations

Israel
Saare Zedek Medical Center	Recruiting
Jerusalem, Israel
Contact: Hilla Ben Pazi, MD Benpazi@gmail.com

Sponsors and Collaborators

Shaare Zedek Medical Center

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 February 09, 2012