Efficacy of Levetiracetam in Oromandibular and Cranial Dystonia

NCT02199509 | Completed Phase 2 Results

• 2 other identifiers: 14015214-N-0152
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Oromandibular Dystonia; Cranial Dystonia

Keywords

Levetiracetam; Cranial Dystonia; Oromandibular Dystonia

Outcome Measures

Primary Outcomes (1)

• Percent Change of the Sum of the Eyes, Mouth, Speech and Swallowing Subscores of the Burke-Fahn-Marsden (BFM) Dystonia Scale.

  The Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) is a measure of dystonia severity. The scale consists of evaluation of nine body parts (eyes, mouth, speech, swallowing, neck, trunk, right arm, right leg, left arm and left leg). The severity and provoking factors for each part are rated using a 5-point scale. These range from 0 (indicating no dystonia) to 4 (indicating the presence of dystonia at rest). The primary outcome measure includes the sum of the eyes, mouth, speech and swallowing subscores and represents the percent change from baseline to either 6 weeks or 14 weeks (representing the end of the 3 week period at the maximum tolerated dose for Levetiracetam or Placebo). The total range for these combined sub scores is 0-16, with higher scores indicating more severe dystonia and 0 indicating absence of dystonia.

  6 and 14 weeks compared to baseline

Secondary Outcomes (2)

• Percent Change of the Sum of the Eyes, Mouth, Speech and Swallowing Subscores of Burke-Fahn-Marsten Dystonia Rating Scale (BFM)

  3 and 11 weeks compared to baseline

• Percent Change of the Sum of Eyes and Upper Face, Lower Face and Jaw and Tongue Subscores of the GDS Rating Scale

  3, 6, 11 and 14 compared to baseline

Interventions

Levetiracetam DRUG

Anticonvulsant

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Interventions

Levetiracetam

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Mark Hallett
• Organization: National Institutes of Health

hallettm@ninds.nih.gov

Study Officials

• Mark Hallett, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 24, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 11, 2017
• Results First Posted: July 11, 2017

Record last verified: 2017-06

Locations

US (1)