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NCT00015457 · ClinicalTrials.gov registry record · Phase 2
Amlodipine Plus Botulinum Toxin for Focal Dystonia
A Phase 2 study of Focal Dystonia, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT00015457: Completed Phase 2 study of Focal Dystonia, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT00015457 is a Phase 2 study of Focal Dystonia that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 16 participants, below the 31-participant average among 8 other Focal Dystonia trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00015457, a Phase 2 study of Focal Dystonia, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
Objective: To determine if the calcium channel blockers, amlodipine can augment the effect of botulinum toxin injections in the treatment of focal dystonia. Study Population: 20 patients with cervical dystonia Design: Double-bind, placebo-controlled clinical trail. Outcome measures: For patients: dystonia rating scales (Twistrs, Fahn-Marsden dystonia scale, NINDS subjective patient rating scale), and hand grip strength. For healthy volunteers: Amplitude of EDB MEP.
Primary Outcome
Rating scale assessing sum of severity of dystonia, disability score and pain scale. Ordinal scale ranging from 0 (least severe) to 30 (maximally severe). Score is maximal response TWSTR rating minus baseline rating.
Conditions Studied
Interventions
- DRUG Amlodipine plus Botulinum toxin
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2001-04 |
| Phase | Phase 2 |
What the finished NCT00015457 record still lists
NCT00015457 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 31-participant average among 8 other Focal Dystonia trials with a reported enrollment target (48% lower).
The record links to 1 condition, with Focal Dystonia appearing as the primary indexed condition, and to 1 intervention - of which Amlodipine plus Botulinum toxin is the first listed.
NCT00015457 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00015457 about?
NCT00015457 is a clinical study titled "Amlodipine Plus Botulinum Toxin for Focal Dystonia". Objective: To determine if the calcium channel blockers, amlodipine can augment the effect of botulinum toxin injections in the treatment of focal dystonia. Study Population: 20 patients with cervical dystonia Design: Double-bind, placebo-controlled clinical trail. Outcome measures: For patients:...
What is the current status of trial NCT00015457?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2001-04.
What conditions does trial NCT00015457 study?
This clinical trial studies the following conditions: Focal Dystonia.
What interventions are being tested in trial NCT00015457?
The interventions under investigation include: Amlodipine plus Botulinum toxin (DRUG).
Who is sponsoring clinical trial NCT00015457?
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 NCT00015457 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
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Where NCT00015457's enrollment target sits among peer trials
16 8th of 8 higher than 1 of 8 other Focal Dystonia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Focal Dystonia 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.
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