Efficacy of Levetiracetam in Oromandibular and Cranial Dystonia

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Etiracetam; Levetiracetam; Piracetam

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.