Phase 2 N=16 Randomized Triple-blind Treatment

Amlodipine Plus Botulinum Toxin for Focal Dystonia

Focal Dystonia

Bottom Line

View on ClinicalTrials.gov: NCT00015457 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2013

Primary outcome: Primary: Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) Sum Score — -6.00; -3.23 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Amlodipine plus Botulinum toxin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Primary completion: Apr 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) Sum Score	-6.00; -3.23	—
SECONDARY Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo	6; 5.5	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00015457). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.