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:	Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Cerebral Palsy Nursing Homes

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 2009
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
group a: Experimental 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.
group b: Experimental 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

group a: Experimental

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.

group b: Experimental

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

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Shaare Zedek Medical Center ( Hilla Ben Pazi, MD )
Study ID Numbers:	59/08
Study First Received:	September 15, 2008
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00752934 History of Changes
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:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Brain Damage, Chronic
Nervous System Diseases
Baclofen
Physiological Effects of Drugs
Central Nervous System Diseases
Neuromuscular Agents
Brain Diseases

Pharmacologic Actions
Cerebral Palsy
GABA Agonists
Muscle Relaxants, Central
Therapeutic Uses
GABA Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010