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Amlodipine Plus Botulinum Toxin for Focal Dystonia

Primary Purpose

Focal Dystonia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Amlodipine plus Botulinum toxin
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Focal Dystonia focused on measuring Writer's Cramp, Calcium Channel Antagonists, Torticollis, Chemodenervation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cervical dystonia

Arm Description

cervical dsytonia patinets

Outcomes

Primary Outcome Measures

Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) Sum Score
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

Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo
Self reported duration of effect in weeks.

Full Information

First Posted
April 18, 2001
Last Updated
March 14, 2013
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00015457
Brief Title
Amlodipine Plus Botulinum Toxin for Focal Dystonia
Official Title
Trial of Amlodipine Combined With Botulinum Toxin Injections for Focal Dystonia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focal Dystonia
Keywords
Writer's Cramp, Calcium Channel Antagonists, Torticollis, Chemodenervation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cervical dystonia
Arm Type
Experimental
Arm Description
cervical dsytonia patinets
Intervention Type
Drug
Intervention Name(s)
Amlodipine plus Botulinum toxin
Primary Outcome Measure Information:
Title
Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) Sum Score
Description
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.
Time Frame
1-2 month maximal rating
Secondary Outcome Measure Information:
Title
Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo
Description
Self reported duration of effect in weeks.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9783280
Citation
Anderson RL, Patel BC, Holds JB, Jordan DR. Blepharospasm: past, present, and future. Ophthalmic Plast Reconstr Surg. 1998 Sep;14(5):305-17.
Results Reference
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PubMed Identifier
2300249
Citation
Jankovic J, Schwartz K. Botulinum toxin injections for cervical dystonia. Neurology. 1990 Feb;40(2):277-80. doi: 10.1212/wnl.40.2.277.
Results Reference
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PubMed Identifier
2213039
Citation
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. doi: 10.1136/jnnp.53.8.633.
Results Reference
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Amlodipine Plus Botulinum Toxin for Focal Dystonia

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