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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 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.

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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.

Conditions Studied

Focal Dystonia

Interventions

  • DRUG Amlodipine plus Botulinum toxin

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2001-04
Phase Phase 2

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

567 total trials

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What the Registry Record Tells You About NCT00015457

The ClinicalTrials.gov registry entry for NCT00015457 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 31-participant average among 8 other Focal Dystonia trials with a reported enrollment target (48% lower). The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.