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NCT02199509 · ClinicalTrials.gov registry record · Phase 2
Efficacy of Levetiracetam in Oromandibular and Cranial Dystonia
A Phase 2 study of Oromandibular Dystonia and Cranial Dystonia, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT02199509: Completed Phase 2 study of Oromandibular Dystonia and Cranial Dystonia, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT02199509 is a Phase 2 study of Oromandibular Dystonia and Cranial Dystonia that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02199509, a Phase 2 study of Oromandibular Dystonia and Cranial Dystonia, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 s
Conditions Studied
Interventions
- DRUG Levetiracetam
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2014-07 |
| Est. Completion | 2016-03 |
| Phase | Phase 2 |
What the finished NCT02199509 record still lists
NCT02199509 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Oromandibular Dystonia appearing as the primary indexed condition, and to 1 intervention - of which Levetiracetam is the first listed.
NCT02199509 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02199509 about?
NCT02199509 is a clinical study titled "Efficacy of Levetiracetam in Oromandibular and Cranial Dystonia". 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...
What is the current status of trial NCT02199509?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2014-07. Estimated completion is 2016-03.
What conditions does trial NCT02199509 study?
This clinical trial studies the following conditions: Oromandibular Dystonia, Cranial Dystonia.
What interventions are being tested in trial NCT02199509?
The interventions under investigation include: Levetiracetam (DRUG).
Who is sponsoring clinical trial NCT02199509?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02199509 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02199509's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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