Baclofen Treatment of Ataxia Telangiectasia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Johns Hopkins University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00640003
First received: March 14, 2008
Last updated: March 3, 2011
Last verified: December 2010

March 14, 2008
March 3, 2011
April 2007
February 2011   (final data collection date for primary outcome measure)
Improvement in the decay constant for velocity storage as assessed by quantitative video examination of eye movement during and after rotation. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Improvement in the decay constant for velocity storage as assessed by quantitative video examination of eye movement during and after rotation. [ Time Frame: months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00640003 on ClinicalTrials.gov Archive Site
Other outcome measures include quantitative measurement of tremor, postural stability and a standard neurologic examination. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Other outcome measures include quantitative measurement of tremor, postural stability and a standard neurologic examination. [ Time Frame: months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Baclofen Treatment of Ataxia Telangiectasia
Not Provided

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). The investigators 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.

Not Provided
Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Ataxia Telangiectasia
  • Drug: Baclofen
    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.
    Other Name: Butanoic Acid
  • Drug: Placebo
    placebo drug
  • Experimental: 1
    Interventions:
    • Drug: Baclofen
    • Drug: Placebo
  • Experimental: 2
    Interventions:
    • Drug: Baclofen
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
12
February 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Teenagers over 12 years old and young adults with A-T may join if they have been evaluated previously in the A-T Clinical Center at Johns Hopkins Hospital and have a measurable abnormality of eye movement.
  • Patients who are presently taking Baclofen will be eligible for the study if they are presently receiving the medication under the direction of Dr. Crawford in the ATCC, and are willing to withdraw from the medication for a period of one month prior to the initial screening visit.
  • Female patients who are sexually active will be given a standard serum HCG pregnancy test.
  • Those who are sexually active will be counseled about necessary precautions against pregnancy during the duration of the trial.

Exclusion Criteria:

  • A positive pregnancy test.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00640003
NA_00002180
No
Thomas Owen Crawford, M.D./Principal Investigator, Johns Hopkins School of Medicine
Johns Hopkins University
Not Provided
Principal Investigator: Thomas O Crawford, M.D. Johns Hopkins School of Medicine
Johns Hopkins University
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP