Overview

Amlodipine Plus Botulinum Toxin for Focal Dystonia

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Treatments:
Amlodipine
Botulinum Toxins
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