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Assessment of the Effect of Botulinum Toxin in Extensor Digitorum Brevis Via Strain Gauge and Nerve Conduction Studies

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Gordon Peterson, Loma Linda University
ClinicalTrials.gov Identifier:
NCT00822523
First received: January 12, 2009
Last updated: August 5, 2016
Last verified: August 2016
Results First Received: October 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Diagnostic
Conditions: Muscle Strength
Botulinum Toxins, Type A
Interventions: Drug: Botulinum Toxin, Type A
Drug: Saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Botulinum Toxin Type A, 20 Units

Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units

Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle

Botulinum Toxin, Type A, 2 Units

Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units

Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle

Placebo

Saline, Single dose, Intramuscular injection into right EDB

Saline: Single Dose, Intramuscular into right EDB muscle


Participant Flow:   Overall Study
    Botulinum Toxin Type A, 20 Units   Botulinum Toxin, Type A, 2 Units   Placebo
STARTED   5   4   4 
COMPLETED   5   4   4 
NOT COMPLETED   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Botulinum Toxin Type A, 20 Units

Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units

Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle

Botulinum Toxin, Type A, 2 Units

Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units

Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle

Placebo

Saline, Single dose, Intramuscular injection into right EDB

Saline: Single Dose, Intramuscular into right EDB muscle

Total Total of all reporting groups

Baseline Measures
   Botulinum Toxin Type A, 20 Units   Botulinum Toxin, Type A, 2 Units   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   4   4   13 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   5   4   4   13 
>=65 years   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 31  (5.9)   26.8  (2.1)   29.5  (2.0)   29.2  (2.3) 
Gender 
[Units: Participants]
       
Female   2   2   1   5 
Male   3   2   3   8 
Region of Enrollment 
[Units: Participants]
       
United States   5   4   4   13 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 ("Force of EDB") After vs. Before Botulinum Toxin Injection Into EDB   [ Time Frame: Baseline (3 times) then following single injection of botulinum toxin into EDB with testing at Day 1, Day 2, Day 4, Day 14, Day 21, and Month 4 ]

2.  Secondary:   Stability of Baseline Measurements of Force   [ Time Frame: Baseline 1 (mean of 3 measurement on the same day of testing) compared with Baseline 2 (mean of 3 measurement on the same day of testing) on a second day compared with Baseline 3 (mean of 3 measurement on the same day of testing) ]

3.  Secondary:   Difference in Force From Day 14 to Day 21   [ Time Frame: Force measured at Day 14 after BoNT/A injction into EDB and Force measured at Day 21 after BoNT/A injction into EDB. ]

4.  Secondary:   Number of Participants With Serious Adverse Effects to onabotulinumtoxinA (Botulinum Type A Neurotoxin)   [ Time Frame: At each visit for nerve conduction studies following injection of onabotulinumtoxinA (botulinum type A neurotoxin) into EDB (Day 0; Day 4; Day 14; Month 4) ]

5.  Secondary:   Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 1000 ms Window).   [ Time Frame: Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement ]

6.  Secondary:   Percent Change of the Surface Electromyogram (SEMG) MRV-500 From EDB After vs. Before Botulinum Toxin Injection Into EDB.   [ Time Frame: Baseline (mean of 3 measurement on the same day of testing) then following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 ]

7.  Secondary:   Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 500 ms Window).   [ Time Frame: Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement ]

8.  Secondary:   Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 200 ms Window).   [ Time Frame: Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement ]

9.  Secondary:   Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 1000 ms Window).   [ Time Frame: Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement ]

10.  Secondary:   Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 500 ms Window).   [ Time Frame: Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement ]

11.  Secondary:   Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 200 ms Window).   [ Time Frame: Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement ]

12.  Secondary:   Correlation in Percent Change of the CMAP (With "Inactive" Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 1000 ms Window).   [ Time Frame: Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement ]

13.  Secondary:   Correlation in Percent Change of the CMAP (With "Inactive" Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 500 ms Window).   [ Time Frame: Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement ]

14.  Secondary:   Correlation in Percent Change of the CMAP (With "Inactive" Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 200 ms Window).   [ Time Frame: Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement ]

15.  Secondary:   Correlation in Percent Change of the CMAP (With "Inactive" Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 1000 ms Window).   [ Time Frame: Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement ]

16.  Secondary:   Correlation in Percent Change of the CMAP (With "Inactive" Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 500 ms Window).   [ Time Frame: Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement ]

17.  Secondary:   Correlation in Percent Change of the CMAP (With "Inactive" Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 200 ms Window).   [ Time Frame: Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Gordon Perterson, MD
Organization: Loma Linda University
phone: 909-558-4000
e-mail: gpeterson@llu.edu


Publications:

Responsible Party: Gordon Peterson, Loma Linda University
ClinicalTrials.gov Identifier: NCT00822523     History of Changes
Other Study ID Numbers: 58360
Study First Received: January 12, 2009
Results First Received: October 16, 2015
Last Updated: August 5, 2016