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Trial record 61 of 116 for:    cervical | "dopa-responsive dystonia" OR "Dystonia"

Amlodipine Plus Botulinum Toxin for Focal Dystonia

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ClinicalTrials.gov Identifier: NCT00015457
Recruitment Status : Completed
First Posted : April 19, 2001
Results First Posted : April 1, 2013
Last Update Posted : April 1, 2013
Sponsor:
Information provided by (Responsible Party):
Barbara Karp, M.D., National Institutes of Health Clinical Center (CC)

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.


Condition or disease Intervention/treatment Phase
Focal Dystonia Drug: Amlodipine plus Botulinum toxin Phase 2

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)


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Trial of Amlodipine Combined With Botulinum Toxin Injections for Focal Dystonia
Study Start Date : April 2001
Actual Primary Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia

Arm Intervention/treatment
Experimental: cervical dystonia
cervical dsytonia patinets
Drug: Amlodipine plus Botulinum toxin



Primary Outcome Measures :
  1. Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) Sum Score [ Time Frame: 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 :
  1. Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo [ Time Frame: 3 months ]
    Self reported duration of effect in weeks.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00015457


Locations
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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)

Publications:
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Responsible Party: Barbara Karp, M.D., MD, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00015457     History of Changes
Other Study ID Numbers: 010147
01-N-0147 ( Other Identifier: NIH )
First Posted: April 19, 2001    Key Record Dates
Results First Posted: April 1, 2013
Last Update Posted: April 1, 2013
Last Verified: March 2013

Keywords provided by Barbara Karp, M.D., National Institutes of Health Clinical Center (CC):
Writer's Cramp
Calcium Channel Antagonists
Torticollis
Chemodenervation

Additional relevant MeSH terms:
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Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Amlodipine
Botulinum Toxins
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Acetylcholine Release Inhibitors
Cholinergic Agents
Neurotransmitter Agents