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| Sponsored by: |
National Institute of Neurological Disorders and Stroke (NINDS) |
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00015457 |
Purpose
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, 20 patients with focal hand dystonia; 40 healthy volunteers.
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.
| Condition | Intervention | Phase |
|
Focal Dystonia |
Drug: Amlodipine plus Botulinum toxin |
Phase II |
| Genetics Home Reference related topics: | early-onset primary dystonia familial paroxysmal nonkinesigenic dyskinesia |
| MedlinePlus related topics: | Dystonia |
| Drug Information available for: | Calcium gluconate Clostridium botulinum toxin Amlodipine Amlodipine besylate |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Efficacy Study |
| Official Title: | Trial of Amlodipine Combined With Botulinum Toxin Injections for Focal Dystonia |
| Estimated Enrollment: | 80 |
| Study Start Date: | April 2001 |
Objective: To determine if the calcium channel blocker, amlodipine can augment the effect of botulinum toxin injections in the treatment of focal dystonia.
Study Population: 20 patients with cervical dystonia, 20 patients with focal hand dystonia; 40 healthy volunteers.
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Patients enrolled in Protocol 85-N-0195, Efficacy and Pathophysiology of Botulinum Toxin for Treatment of Involuntary Movement Disorders are eligible for enrollment if they meet the following inclusion and exclusion criteria.
Good general health
Focal hand dystonia or cervical dystonia
Stable response to botulinum toxin demonstrated through a series of at least 3 injections over a period of at least a year
Benefit from the 3 immediately prior btx injections rated as 75% or less or a duration of benefit lasting less than or equal to 2 months
No other medications for dystonia
EXCLUSION CRITERIA:
Cervical dystonia accompanied by dysphagia or dyspnea, either before or with botulinum toxin injection
Present or past cardiac disease, hypertension, arrhythmia or congestive heart failure
Anterocollis or other neck dystonia requiring bilateral anterior neck muscle injections
Use of concomitant medications affecting calcium channels or those metabolized by the cytochrome p450 3A4 system including grapefruit juice, St. John's wort, HIV protease inhibitors, cimetidine, antibiotics (macrolides, fluoroquinones, antifungal, rifampin), antidepressants (fluvoxamine, norfluoxetine), barbiturates, anticonvulsants (carbamazepine, phenytoin), oral diabetes agents (pioglitazone, troglitazone), and glucocorticoids
Allergy to amlodipine or related compounds
Pregnany/ nursing
Age less than 18 years of age
Abnormal EKG
Abnormal coagulation profile or liver function tests
Use of anticoagulants
Contacts and Locations| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: TTY | 1-866-411-1010 |
| United States, Maryland | |||||
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting | ||||
| Bethesda, Maryland, United States, 20892 | |||||
More Information
NIH Clinical Center Detailed Web Page
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| Responsible Party: | National Institutes of Health ( Barbara I. Karp, M.D./National Institute of Neurological Disorders and Stroke ) |
| Study ID Numbers: | 010147, 01-N-0147 |
| First Received: | April 18, 2001 |
| Last Updated: | October 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00015457 |
| Health Authority: | United States: Federal Government |
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