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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Shaare Zedek Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00752934
First received: September 15, 2008
Last updated: April 17, 2011
Last verified: September 2008
  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 4

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:


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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Muscle Relaxants, Central
Physiological Effects of Drugs
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014