Amlodipine Plus Botulinum Toxin for Focal Dystonia

Phase 2

Completed

• Conditions: Focal Dystonia
• Interventions: Drug: Amlodipine plus Botulinum toxin

• Registration Number: NCT00015457
• Lead Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

Brief 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.

Detailed 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)

Study Timeline

• Study Start: 2001-04
• Study First Submitted: 2001-04-18
• Study First Submitted QC: 2001-04-18
• Study First Posted: 2001-04-19
• Primary Completion: 2009-04
• Status Verified: 2013-03
• Results First Submitted: 2013-03-14
• Results First Submitted QC: 2013-03-14
• Last Update Submitted: 2013-03-14
• Results First Posted: 2013-04-01
• Last Update Posted: 2013-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
cervical dystonia	Amlodipine plus Botulinum toxin	cervical dsytonia patinets

Primary Outcome Measures

Name	Time	Method
Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) Sum Score	1-2 month maximal rating	Rating scale assessing sum of severity of dystonia, disability score and pain scale. Ordinal scale ranging from 0 (least severe) to 30 (maximally severe). Score is maximal response TWSTR rating minus baseline rating.

Secondary Outcome Measures

Name	Time	Method
Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo	3 months	Self reported duration of effect in weeks.

Trial Locations

Locations (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike; 🇺🇸 Bethesda, Maryland, United States