Amlodipine Plus Botulinum Toxin for Focal Dystonia
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About
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.
Full description
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
Design: Double-bind, placebo-controlled clinical trail.
Outcome measures: dystonia rating scales (TWISTRS)
Enrollment
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Inclusion and exclusion criteria
- INCLUSION CRITERIA:
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
16 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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