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Sponsored by: |
Johns Hopkins University |
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Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00640003 |
This research is being done to find out if Baclofen, a medicine that is often used for the treatment of abnormal stiffness, might also be useful to treat some of the neurologic problems caused by ataxia telangiectasia (A-T). We also want to find out if there are better ways to measure the problems of ataxia and abnormal eye movement for future studies of medication in ataxia telangiectasia.
Condition | Intervention | Phase |
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Ataxia Telangiectasia (A-T) |
Drug: Baclofen or Placebo |
Phase 0 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 12 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Baclofen or Placebo
Drug given by orally via capsules. Escalation steps in 4-day intervals. Step 1: 5mg QAM. Step 2: 5mg BID. Step 3: 5mg TID. Step 4: 10mg QAM, 5mg BID. Step 5: 10mg BID, 5mg QMid-day. Step 6: 10mg TID. Step 6 will last up to 2 weeks. De-escalation will start from highest dose step and work backwards in 2-day intervals. Complete drug administration of escalating, staying constant at 10mg TID and de-escalating will be done with both drug and placebo.
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2: Experimental |
Drug: Baclofen or Placebo
Drug given by orally via capsules. Escalation steps in 4-day intervals. Step 1: 5mg QAM. Step 2: 5mg BID. Step 3: 5mg TID. Step 4: 10mg QAM, 5mg BID. Step 5: 10mg BID, 5mg QMid-day. Step 6: 10mg TID. Step 6 will last up to 2 weeks. De-escalation will start from highest dose step and work backwards in 2-day intervals. Complete drug administration of escalating, staying constant at 10mg TID and de-escalating will be done with both drug and placebo.
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Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bessy Guevara, B.A. | 443-287-6294 | bguevar1@jhmi.edu |
United States, Maryland | |
Johns Hopkins Hospital | Recruiting |
Baltimore, Maryland, United States, 21287 | |
Contact: Bessy Guevara, BA 443-287-6294 bguevar1@jhmi.edu | |
Principal Investigator: Thomas O Crawford, M.D. |
Principal Investigator: | Thomas O Crawford, M.D. | Johns Hopkins School of Medicine |
Responsible Party: | Johns Hopkins School of Medicine ( Thomas Owen Crawford, M.D./Principal Investigator ) |
Study ID Numbers: | NA_00002180 |
Study First Received: | March 14, 2008 |
Last Updated: | March 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00640003 |
Health Authority: | United States: Institutional Review Board |
AT Ataxia Telangiectasia |
Metabolic Diseases Ataxia-Telangiectasia Baclofen Vascular Diseases Central Nervous System Diseases Brain Diseases Dyskinesias Immunologic Deficiency Syndromes Signs and Symptoms Cerebellar Ataxia |
Genetic Diseases, Inborn Telangiectasis Ataxia Neurologic Manifestations Ataxia Telangiectasia Metabolic disorder Cerebellar Diseases Cerebellar ataxia Spinocerebellar Ataxias Neurocutaneous Syndromes |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Immune System Diseases Nervous System Diseases DNA Repair-Deficiency Disorders Physiological Effects of Drugs Neuromuscular Agents Pharmacologic Actions |
Muscle Relaxants, Central Therapeutic Uses GABA Agonists GABA Agents Cardiovascular Diseases Peripheral Nervous System Agents Central Nervous System Agents |