Status:
COMPLETED
Efficacy of Levetiracetam in Oromandibular and Cranial Dystonia
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Oromandibular Dystonia
Cranial Dystonia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 dyst...
Detailed Description
Objectives: --To determine the efficacy of levetiracetam (LVT) for reducing the symptoms of subjects with oromandibular dystonia (OMD) or cranial dystonia (CD) as assessed by dystonia rating scales a...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA FOR THE PARTICIPANTS:
- Be at least 18 years of age and less than or equal to 80 years of age.
- Must be able to provide consent.
- Primary OMD or CD diagnosed by movement disorders specialist.
- No history of receiving LVT.
- 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.
- If the subject was injected with BoNT, the latest dose must be injected at least 12 weeks before participation in this study.
- Subject is willing to not receive any BoNT injections during the entire study.
- EXCLUSION CRITERIA FOR THE PARTICIPANTS:
- Psychiatric co-morbidities such as depression, psychosis or phobic disorders.
- 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.
- Secondary OMD or CD.
- Postural instability, frequent falling, severe vertigo or dizziness and severe ataxia.
- Inability to take medication via oral route due to severe degree of OMD.
- An estimated creatinine clearance (eCrCL) less than 50 mL/min.
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02199509
Start Date
July 1 2014
End Date
March 1 2016
Last Update
July 11 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892