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Subcutaneous Botulinum Toxin for Cutaneous Allodynia - Enriched Responder Trial

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ClinicalTrials.gov Identifier: NCT00822926
Recruitment Status : Terminated
First Posted : January 15, 2009
Results First Posted : August 15, 2017
Last Update Posted : August 15, 2017
Sponsor:
Information provided by (Responsible Party):
Sean Mackey, Stanford University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pain
Interventions: Drug: Botulinum Toxin Type A
Drug: Saline

  Participant Flow

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
Placebo Then Botox Injection 1: Saline- Subcutaneous injection of saline into scar tissue Injection 2: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue
Botox Then Placebo Injection 1: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue Injection 2: Saline- Subcutaneous injection of saline into scar tissue

Participant Flow for 3 periods

Period 1:   First Injection Visit
    Placebo Then Botox   Botox Then Placebo
STARTED   2   3 
COMPLETED   2   3 
NOT COMPLETED   0   0 

Period 2:   Washout (Varies Based on Scheduling)
    Placebo Then Botox   Botox Then Placebo
STARTED   2   3 
COMPLETED   2   3 
NOT COMPLETED   0   0 

Period 3:   Second Injection Visit
    Placebo Then Botox   Botox Then Placebo
STARTED   2   3 
COMPLETED   1   2 
NOT COMPLETED   1   1 
Lost to Follow-up                1                0 
Withdrawal by Subject                0                1 



  Baseline Characteristics

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
Placebo Then Botox Injection 1: Saline- Subcutaneous injection of saline into scar tissue Injection 2: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue
Botox Then Placebo Injection 1: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue Injection 2: Saline- Subcutaneous injection of saline into scar tissue
Total Total of all reporting groups

Baseline Measures
   Placebo Then Botox   Botox Then Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 2   2   4 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      2 100.0%      2 100.0%      4 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 49  (4.24)   48.5  (7.78)   48.75  (5.12) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1  50.0%      2 100.0%      3  75.0% 
Male      1  50.0%      0   0.0%      1  25.0% 
Region of Enrollment 
[Units: Participants]
     
United States   2   2   4 


  Outcome Measures

1.  Primary:   Time to Analgesic Failure   [ Time Frame: Duration of trial (2-20 months, depending on how long pain relief lasts) ]

2.  Secondary:   Improvement in Psychosocial Function as Assessed by Outcomes as Dictated by the IMMPACT Guidelines   [ Time Frame: Duration of trial (2-20 months, depending on how long pain relief lasts) ]

3.  Secondary:   NRS Score Three Weeks After Injection   [ Time Frame: 3 weeks after injection ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Sean Mackey, Chief, Division of Pain Medicine, Director, Stanford Systems Neuroscience and Pain Lab
Organization: Stanford University School of Medicine
phone: (650) 498-6477
e-mail: smackey@stanford.edu



Responsible Party: Sean Mackey, Stanford University
ClinicalTrials.gov Identifier: NCT00822926     History of Changes
Other Study ID Numbers: SU-01072009-1499
15601
First Submitted: January 14, 2009
First Posted: January 15, 2009
Results First Submitted: April 17, 2017
Results First Posted: August 15, 2017
Last Update Posted: August 15, 2017