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| ID | Type | Description | Link |
|---|---|---|---|
| 01-N-0147 | Other Identifier | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cervical dystonia | Experimental | cervical dsytonia patinets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlodipine plus Botulinum toxin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1-2 month maximal rating |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo | Self reported duration of effect in weeks. | 3 months |
Not provided
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9783280 | Background | Anderson RL, Patel BC, Holds JB, Jordan DR. Blepharospasm: past, present, and future. Ophthalmic Plast Reconstr Surg. 1998 Sep;14(5):305-17. | |
| 2300249 | Background | Jankovic J, Schwartz K. Botulinum toxin injections for cervical dystonia. Neurology. 1990 Feb;40(2):277-80. doi: 10.1212/wnl.40.2.277. |
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Patients were excluded if response to previous btx injections were not stable, serious medical conditions, pregnancy, abnormal medical screening
Patients recruited from a medical clinic providing botulinum toxin treatment for cervical dystonia. Patients recruited between 6/21/01 and 10/19/06
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| ID | Title | Description |
|---|---|---|
| FG000 | Amlodipine Then Placebo | Patients with cervical dystonia receiving botulinum toxin injections plus Amlodipine during the first period and botulinum toxin injections plus Placebo during the second period. |
| FG001 | Placebo Then Amlodipine | Patients with cervical dystonia receiving botulinum toxin injections plus Placebo during the first period and botulinum toxin injections plus Amlodipine during the second period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
|
| |||||||||||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cervical Dystonia | All participants enrolled in study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | age >18 |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Total enrolled less withdrawals from study. One participant completed the study but did not yield analyzeable data | Posted | Mean | Standard Deviation | units on a scale | 1-2 month maximal rating |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Amlodipine | Patients receiving Amlodipine plus botulinum toxin injections during either period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypereosinophila | Blood and lymphatic system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara I Karp, MD | National Institutes of Health | 301-496-0150 | karpb@ninds.nih.gov |
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| ID | Term |
|---|---|
| D020821 | Dystonic Disorders |
| D014103 | Torticollis |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004421 | Dystonia |
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| ID | Term |
|---|---|
| D017311 | Amlodipine |
| D001905 | Botulinum Toxins |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 2213039 | Background | 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. |
| NOT COMPLETED |
|
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo | Self reported duration of effect in weeks. | Total enrolled less withdrawals. Less one participant who completed the study but who did not yield analyzeable data. | Posted | Median | Full Range | weeks | 3 months |
|
|
|
| 0 |
| 16 |
| 2 |
| 16 |
| EG001 | Placebo | Patients receiving Placebo plus botulinum toxin injections during either period. | 0 | 16 | 2 | 16 |
| dysphagia | General disorders |
|
| swelling | Skin and subcutaneous tissue disorders | ankle edema |
|
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| D020820 |
| Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008666 |
| Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |