Efficacy of Levetiracetam in Oromandibular and Cranial Dystonia
Condition: Oromandibular Dystonia; Cranial Dystonia
MeSH terms: Dystonia; Dystonic Disorders
Intervention: Levetiracetam
Intervention description: Anticonvulsant
Intervention MeSH terms: Levetiracetam
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Levetiracetam; Cranial Dystonia; Oromandibular Dystonia

Summary:

      Background:

      - People with dystonia cannot control their muscle contractions. This disorder can affect
      different body areas. When it affects the face, tongue, and jaw, it is called oromandibular
      dystonia (OMD) or cranial dystonia (CD). Researchers want to find out if a drug that treats
      seizures may help people with this kind of dystonia.

      Objective:

      - To see if levetiracetam can improve symptoms of jaw or face dystonia.

      Eligibility:

      - Adults ages 18 to 80 years with OMD or CD.

      Design:

        -  Participants will be screened with a medical history and physical exam. Researchers will
           test how severe their dystonia is.

        -  Participants will have blood drawn through a needle in the arm.

        -  Participants will be assigned to take either levetiracetam or placebo.

        -  Phase 1:

        -  Participants will start with one 500-mg tablet twice daily. The dose will be increased
           by 500 mg every 3 days. The maximum dose will be 4000 mg a day over 3 weeks.
           Participants who cannot tolerate that will take the highest dose they can.

        -  Participants will return for study visits at weeks 3 and 6. They will be asked about
           their health, side effects, and symptoms of depression. They will have a neurological
           examination and test of their dystonia.

        -  After the week 6 visit, participants will taper and stop the study drug over about 1
           week.

        -  Phase 2 begins one week later. Participants will repeat phase 1, but with the other
           drug.

        -  After phase 2, participants will return to their usual clinics. They will be told how to
           stop taking the drug. They will have a follow-up phone call 2 weeks later.
    

Eligibility criteria:

        -  INCLUSION CRITERIA FOR THE PARTICIPANTS:

               1. Be at least 18 years of age and less than or equal to 80 years of age.

               2. Must be able to provide consent.

               3. Primary OMD or CD diagnosed by movement disorders specialist.

               4. No history of receiving LVT.

               5. If the subject is using other medications for their dystonia such as
                  anticholinergics, baclofen, benzodiazepines or tetrabenazine, the dosage must
                  stay the same starting 4 weeks before participation and throughout the duration
                  of the study. Subjects will also be prohibited from starting new medications for
                  their dystonia.

               6. If the subject was injected with BoNT, the latest dose must be injected at least
                  12 weeks before participation in this study.

               7. Subject is willing to not receive any BoNT injections during the entire study.

        EXCLUSION CRITERIA FOR THE PARTICIPANTS:

          1. Psychiatric co-morbidities such as depression, psychosis or phobic disorders.

          2. Has had a history of brain tumor, stroke, documented history of peripheral trauma to
             the mouth, jaw or face within a year from the onset of dystonia, epilepsy or seizures.

          3. Secondary OMD or CD.

          4. Postural instability, frequent falling, severe vertigo or dizziness and severe ataxia.

          5. Inability to take medication via oral route due to severe degree of OMD.

          6. An estimated creatinine clearance (eCrCL) less than 50 mL/min.

          7. Pregnant, lactating or planning to become pregnant in 6 months. Women who are able to
             get pregnant must be willing to use an effective method of contraception from the time
             of enrollment until 3 months after the last dose of the study medication.