CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
Amlodipine plus Botulinum toxindrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Focal hand dystonia or cervical dystonia
  • ✓Stable response to botulinum toxin with at least 3 injections over at least 1 year
  • ✓Suboptimal benefit (≤75%) or short duration (≤2 months) from the 3 most recent BTX injections
  • ✓Good general health
Key exclusion· 10
  • ✕Any history of cardiac disease, hypertension, arrhythmia, or congestive heart failure
  • ✕Cervical dystonia with swallowing or breathing difficulty (before or with BTX)
  • ✕Anterocollis or bilateral anterior neck muscle injections required
  • ✕Concomitant medications affecting calcium channels or CYP3A4 metabolism (macrolides, fluoroquinolones, antifungals, rifampin, fluvoxamine, carbamazepine, phenytoin, pioglitazone, troglitazone, glucocorticoids, grapefruit juice, St. John's wort, HIV protease inhibitors, cimetidine)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00015457
NCT00015457Phase 2Completed
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Trial of Amlodipine Combined With Botulinum Toxin Injections for Focal Dystonia

National Institute of Neurological Disorders and Stroke (NINDS)·interventional·Posted Apr 19, 2001·Updated Apr 1, 2013

In Brief

A Phase 2 clinical trial evaluating Amlodipine plus Botulinum toxin for Focal Dystonia. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFocal Dystonia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 19, 2001
Enrollment StartApr 1, 2001
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 8 yearsPosted 25.2 years ago

Interventions

Amlodipine plus Botulinum toxindrug