Comparison of Keppra and Clonidine in the Treatment of Tics
Condition: Tic Disorders; Tourette Syndrome
MeSH terms: Tourette Syndrome; Tic Disorders; Syndrome
Intervention: Levetiracetam; Clonidine
Intervention description: The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.; The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
Intervention MeSH terms: Clonidine; Levetiracetam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 7 Years
Maximum age: 19 Years
Healthy volunteers: No
Keywords: Tics; Tourette syndrome; levetiracetam; clonidine

Summary:

      The goal of this study is to confirm that levetiracetam has a better tic-suppressing profile
      than that of the widely used tic-suppressing medication, clonidine. More specifically, the
      investigators hypothesize that in a 15 week placebo run-in, double-blind, medication
      cross-over trial; levetiracetam will be more effective and have fewer side-effects than
      clonidine.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients will be included in this study if they meet the following criteria:

          -  Tourette syndrome criteria based on the TS Classification Study Group [1993], which
             includes onset before 18 years, multiple involuntary motor tics, one or more vocal
             tics, a waxing and waning course, the gradual replacement of old symptoms with new
             ones, the presence of tics for more than one year, the absence of other medical
             explanations for tics, and observation of tics by a reliable examiner;

          -  Age 7 to 19 years, either gender;

          -  Observable tics, achieving a minimum score of > 22 on the Total Tic score of Yale
             Global Tic Severity Scale (YGTSS);

          -  Tic symptoms severe enough to warrant therapy;

          -  The concurrent use of other tic-suppressing medications will be permitted, if the
             subject has been on a stable dose for more than three weeks and agrees to maintain a
             constant dosage throughout the study;

          -  Tics are not controlled with current medication or individuals are tic suppressing
             drug naive.

        Exclusion Criteria:

        Exclusion criteria include the following:

          -  Secondary tics;

          -  Significant medical illness

          -  Current major depression, generalized anxiety disorder, separation anxiety disorder,
             psychotic symptoms (based on clinical evaluation), pervasive developmental disorder,
             autism, mental retardation (I.Q. less than 70), anorexia/bulimia, or substance abuse.
             Subjects with co-morbid ADHD, obsessive compulsive disorder (OCD), and conduct
             disorder will not be excluded;

          -  pregnancy;

          -  Hypersensitivity to levetiracetam or clonidine;

          -  baseline weight of less than 25 kilograms.