Amlodipine Plus Botulinum Toxin for Focal Dystonia - Full Text View

Sponsor:	National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00015457

Purpose

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, 20 patients with focal hand dystonia; 40 healthy volunteers.

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.

Condition	Intervention	Phase
Focal Dystonia	Drug: Amlodipine plus Botulinum toxin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Efficacy Study
Official Title:	Trial of Amlodipine Combined With Botulinum Toxin Injections for Focal Dystonia

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset primary dystonia familial paroxysmal nonkinesigenic dyskinesia

MedlinePlus related topics: Calcium Dystonia

Drug Information available for: Amlodipine Amlodipine besylate Clostridium botulinum toxin

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:

Change in response to botulinum toxin injection. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in duration of response to bolulinum toxin injection. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	April 2001
Estimated Study Completion Date:	April 2009

Intervention Details:

N/A

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, 20 patients with focal hand dystonia; 40 healthy volunteers.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00015457

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

More Information

Publications:

Anderson RL, Patel BC, Holds JB, Jordan DR. Blepharospasm: past, present, and future. Ophthal Plast Reconstr Surg. 1998 Sep;14(5):305-17.

Jankovic J, Schwartz K. Botulinum toxin injections for cervical dystonia. Neurology. 1990 Feb;40(2):277-80.

Jankovic J, Schwartz K, Donovan DT. Botulinum toxin treatment of cranial-cervical dystonia, spasmodic dysphonia, other focal dystonias and hemifacial spasm. J Neurol Neurosurg Psychiatry. 1990 Aug;53(8):633-9.

Responsible Party:	National Institutes of Health ( Barbara I. Karp, M.D./National Institute of Neurological Disorders and Stroke )
Study ID Numbers:	010147, 01-N-0147
Study First Received:	April 18, 2001
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00015457 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Writer's Cramp
Calcium Channel Antagonists
Torticollis
Chemodenervation

Additional relevant MeSH terms:

Dystonic Disorders
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Nervous System Diseases
Calcium Channel Blockers
Dystonia
Central Nervous System Diseases
Cardiovascular Agents
Antihypertensive Agents

Dyskinesias
Pharmacologic Actions
Amlodipine
Membrane Transport Modulators
Signs and Symptoms
Botulinum Toxins
Movement Disorders
Therapeutic Uses
Neurologic Manifestations
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 22, 2009