Baclofen Treatment of Ataxia Telangiectasia
Information source: Johns Hopkins University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ataxia Telangiectasia (A-T)
Intervention: Baclofen or Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Johns Hopkins University Official(s) and/or principal investigator(s):
Thomas O Crawford, M.D., Principal Investigator, Affiliation: Johns Hopkins School of Medicine
Overall contact:
Bessy Guevara, B.A., Phone: 443-287-6294, Email: bguevar1@jhmi.edu
Summary
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.
Clinical Details
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Improvement in the decay constant for velocity storage as assessed by quantitative video examination of eye movement during and after rotation.
Secondary outcome: Other outcome measures include quantitative measurement of tremor, postural stability and a standard neurologic examination.
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Bessy Guevara, B.A., Phone: 443-287-6294, Email: bguevar1@jhmi.edu
Johns Hopkins Hospital, Baltimore, Maryland 21287, United States; Recruiting
Bessy Guevara, BA, Phone: 443-287-6294, Email: bguevar1@jhmi.edu
Thomas O Crawford, M.D., Principal Investigator
Additional Information
Starting date: April 2007
Ending date: April 2009
Last updated: March 19, 2008
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