Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 116 for:    cervical | "dopa-responsive dystonia" OR "Dystonia"

Botox for Cervical Dystonia Following EMG Mapping

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00773253
Recruitment Status : Completed
First Posted : October 16, 2008
Results First Posted : October 13, 2011
Last Update Posted : October 13, 2011
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cervical Dystonia
Intervention Drug: Botulinum toxin A
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard EMG Guided Injections Then Multi-channel Injections Multi-channel EMG-guided Botox Injection Then Standard EMG Inj
Hide Arm/Group Description All patients will undergo injection using conventional single channel (standard)EMG-guided technique. This will be used as a baseline for multi-channel mapping-based injections. Patients will be randomized to undergo single-channel vs. multi-channel assessment upon study entry and will then cross over to the alternate arm. Patients will receive multi-channel EMG-guided Botox injection before or after they have been treated with single-channel (standard) EMG-guided Botox, depending on which group they are assigned in the cross-over design.
Period Title: First Intervention (Week 0-24)
Started 5 5
Completed 5 4
Not Completed 0 1
Reason Not Completed
Frontalis Test Negative             0             1
Period Title: Second Intervention (Week 24-48)
Started 5 4
Completed 5 4
Not Completed 0 0
Arm/Group Title Standard EMG Guided Injections Then Multi-channel Multi-channel EMG-guided Botox Injection Then Single Channel Total
Hide Arm/Group Description All patients will undergo injection using conventional single channel EMG-guided technique. This will be used as a baseline for multi-channel mapping-based injections. Patients will be randomized to undergo single-channel vs. multi-channel assessment upon study entry and will then cross over to the alternate arm. Patients will receive multi-channel EMG-guided Botox injection before or after they have been treated with single-channel EMG-guided Botox, depending on which group they are assigned in the cross-over design. Total of all reporting groups
Overall Number of Baseline Participants 5 5 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
 100.0%
5
 100.0%
10
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 10 participants
55.4  (5.2) 54.7  (5.1) 55.4  (5.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
Female
2
  40.0%
2
  40.0%
4
  40.0%
Male
3
  60.0%
3
  60.0%
6
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 5 participants 10 participants
5 5 10
1.Primary Outcome
Title Pre- and Post-injection Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS): Global Clinical Impression Scale (GCI); Visual Analog Scale(VAS)
Hide Description [Not Specified]
Time Frame pre-injection, week 16, 20, 36, and 40
Outcome Measure Data Not Reported
2.Primary Outcome
Title Mean Percentage Change in Total Toronto Western Spasmodic Torticollis Rating Scale
Hide Description Mean Percentage change in Toronto Western Spasmodic Torticollis Rating Scale. This scale ranges from 0 (normal) to 85 (very severe).
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed all phases of the study
Arm/Group Title Standard EMG Guided Injections Multi-channel EMG-guided Botox Injection
Hide Arm/Group Description:
All patients underwent single channel (standard)EMG-guided technique.
Patients will receive multi-channel EMG-guided Botox injection.
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: percent change in units on the scale
9  (20.8) 23.5  (15.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard EMG Guided Injections Multi-channel EMG-guided Botox Injection
Hide Arm/Group Description All patients underwent single channel (standard)EMG-guided technique. Patients will receive multi-channel EMG-guided Botox injection.
All-Cause Mortality
Standard EMG Guided Injections Multi-channel EMG-guided Botox Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard EMG Guided Injections Multi-channel EMG-guided Botox Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard EMG Guided Injections Multi-channel EMG-guided Botox Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/10 (0.00%) 
One patient received single channel injection, but did not get multi-channel injection because the frontalis test showed immunity to botulinum toxin indicating no possibility of clinical benefit. This is an exclusion criterion.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Graham A. Glass, MD
Organization: University of California San Francisco
Phone: 415-353-2311
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00773253     History of Changes
Other Study ID Numbers: Allergan cervical dystonia
First Submitted: October 14, 2008
First Posted: October 16, 2008
Results First Submitted: February 15, 2011
Results First Posted: October 13, 2011
Last Update Posted: October 13, 2011