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Amlodipine Plus Botulinum Toxin for Focal Dystonia

This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), March 2008

Sponsored by: 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

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

MedlinePlus related topics:   Dystonia   

Drug Information available for:   Calcium gluconate    Clostridium botulinum toxin    Amlodipine    Amlodipine besylate   

U.S. FDA Resources

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

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

Intervention Details:
    Drug: Amlodipine plus Botulinum toxin
    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

Contacts
Contact: Patient Recruitment and Public Liaison Office     (800) 411-1222     prpl@mail.cc.nih.gov    
Contact: TTY     1-866-411-1010    

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

Sponsors and Collaborators
  More Information


NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site
 

Publications:

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
First Received:   April 18, 2001
Last Updated:   October 6, 2008
ClinicalTrials.gov Identifier:   NCT00015457
Health Authority:   United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Writer's Cramp  
Calcium Channel Antagonists  
Torticollis  
Chemodenervation  

Study placed in the following topic categories:
Dystonic Disorders
Signs and Symptoms
Torticollis
Botulinum Toxins
Movement Disorders
Central Nervous System Diseases
Neurologic Manifestations
Dystonia
Muscle Cramp
Focal dystonia
Dyskinesias
Amlodipine

Additional relevant MeSH terms:
Membrane Transport Modulators
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Therapeutic Uses
Nervous System Diseases
Calcium Channel Blockers
Cardiovascular Agents
Antihypertensive Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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