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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)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Focal Dystonia
Intervention Drug: Amlodipine plus Botulinum toxin
Enrollment 16
Recruitment Details Patients recruited from a medical clinic providing botulinum toxin treatment for cervical dystonia. Patients recruited between 6/21/01 and 10/19/06
Pre-assignment Details Patients were excluded if response to previous btx injections were not stable, serious medical conditions, pregnancy, abnormal medical screening
Arm/Group Title Amlodipine Then Placebo Placebo Then Amlodipine
Hide Arm/Group Description Patients with cervical dystonia receiving botulinum toxin injections plus Amlodipine during the first period and botulinum toxin injections plus Placebo during the second period. Patients with cervical dystonia receiving botulinum toxin injections plus Placebo during the first period and botulinum toxin injections plus Amlodipine during the second period.
Period Title: First Intervention
Started 8 8
Completed 8 5
Not Completed 0 3
Reason Not Completed
Adverse Event             0             2
Lack of Efficacy             0             1
Period Title: Second Intervention
Started 8 5
Completed 7 5
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Cervical Dystonia
Hide Arm/Group Description All participants enrolled in study
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
  93.8%
>=65 years
1
   6.3%
[1]
Measure Description: age >18
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
13
  81.3%
Male
3
  18.8%
1.Primary Outcome
Title Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) Sum Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Total enrolled less withdrawals from study. One participant completed the study but did not yield analyzeable data
Arm/Group Title Amlodipine Placebo
Hide Arm/Group Description:
Patients receiving Amlodipine plus botulinum toxin injections during either period.
Patients receiving Placebo plus botulinum toxin injections during either period.
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.00  (10.23) -3.23  (6.06)
2.Secondary Outcome
Title Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo
Hide Description Self reported duration of effect in weeks.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Total enrolled less withdrawals. Less one participant who completed the study but who did not yield analyzeable data.
Arm/Group Title Amlodipine Placebo
Hide Arm/Group Description:
Patients receiving Amlodipine plus botulinum toxin injections during either period.
Patients receiving Placebo plus botulinum toxin injections during either period.
Overall Number of Participants Analyzed 11 11
Median (Full Range)
Unit of Measure: weeks
6
(1 to 12)
5.5
(2 to 12)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Amlodipine Placebo
Hide Arm/Group Description Patients receiving Amlodipine plus botulinum toxin injections during either period. Patients receiving Placebo plus botulinum toxin injections during either period.
All-Cause Mortality
Amlodipine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Amlodipine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/16 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Amlodipine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/16 (12.50%)      2/16 (12.50%)    
Blood and lymphatic system disorders     
hypereosinophila  1/16 (6.25%)  1 0/16 (0.00%)  0
General disorders     
dysphagia  0/16 (0.00%)  0 1/16 (6.25%)  1
Skin and subcutaneous tissue disorders     
swelling [1]  1/16 (6.25%)  1 1/16 (6.25%)  1
[1]
ankle edema
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Barbara I Karp, MD
Organization: National Institutes of Health
Phone: 301-496-0150
Responsible Party: Barbara Karp, M.D., 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 Submitted: April 18, 2001
First Posted: April 19, 2001
Results First Submitted: March 14, 2013
Results First Posted: April 1, 2013
Last Update Posted: April 1, 2013