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出境医 / 临床实验 / Abobotulinumtoxina Efficacy in Post-Traumatic Headache

Abobotulinumtoxina Efficacy in Post-Traumatic Headache

Study Description
Brief Summary:
This study will evaluate the efficacy of abobotulinumtoxina on Veterans with post-traumatic headache

Condition or disease Intervention/treatment Phase
Post-Traumatic Headache Drug: AbobotulinumtoxinA Drug: Normal saline Phase 4

Detailed Description:

A significant proportion of headaches occur following head trauma, and therefore are referred to as post-traumatic headaches (PTH). Traumatic brain injury (TBI) is highly prevalent in the Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) population and consequently there has been a rise in PTH in the clinical setting at VA hospitals. Botulinum toxin type A (BoNT-A) has been shown to be effective in treating chronic migraine and chronic daily headache. It is therefore reasonable to predict that BoNT-A may also be effective in treating PTH. This study proposes that PTH and its associated symptoms may respond positively to BoNT-A treatment due to its similar pathophysiology and clinical resemblance to other headache disorders including tension type headache, typical migraine with or without aura, and chronic daily headache.

Study Design: Veterans with mild, moderate or severe brain injury with a headache developing within 7 days after head trauma and persisting greater than 3 months were recruited from the Veterans Affairs Greater Los Angeles Healthcare System. The study is a prospective, double-blind, randomized, placebo-controlled, cross-over trial.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description: The project statistician used a computer-based random number generator to create a randomized treatment allocation schedule that was provided to the pharmacist and nurse practitioner who did not disclose this information. The pharmacist provided the nurse practitioner with the medication in an unlabeled bag, which either included BoNT-A or Normal Saline. Patients were randomized to receive BoNT-A or Normal Saline as first injection. The nurse practitioner reconstituted the medication in a separate room and then provided the investigator with unlabeled syringes.
Primary Purpose: Treatment
Official Title: Abobotulinumtoxina Efficacy in Post-Traumatic Headache
Actual Study Start Date : August 1, 2013
Actual Primary Completion Date : February 2, 2017
Actual Study Completion Date : February 2, 2017
Arms and Interventions
Arm Intervention/treatment
Experimental: Abobotulinumtoxina
300 units of abobotulinumtoxinA was reconstituted with 2.4 ml of 0.9% preservative free sterile saline so that each 0.1 ml contained 12.5 units of Abobotulinumtoxina 0.1 ml were injected into 31 sites of the head and neck
 Drug: AbobotulinumtoxinA
Subjects were injected with 0.1 ml (12.5 units of Abobotulinumtoxina) into 31 distinct muscle locations in the head and neck
Other Name: Dysport
Placebo Comparator: Placebo
0.9% preservative free sterile saline. 0.1 ml were injected into 31 sites of the head and neck
 Drug: Normal saline
Subjects were injected with 0.1 ml of preservative free normal saline into 31 distinct muscle locations in the head and neck
Outcome Measures
Primary Outcome Measures :
  1. Incidence of headaches from baseline [ Time Frame: evaluation from time of injection until completion of 12 week follow-up ]
    Evaluation in weekly incidence of headaches from baseline based on headache diary or weekly phone follow-up


Secondary Outcome Measures :
  1. Intensity of headache pain [ Time Frame: evaluation from time of injection until completion of 12 week follow-up ]
    Evaluation of pain intensity using score of headache on Numerical Rating Scale (NRS) over time. The NRS is an 11-point scale for patient self-reporting of pain with 0 being no pain and 10 being the most severe pain.

  2. Number of headache days per week [ Time Frame: evaluation from time of injection until completion of 12 week follow-up ]
    Evaluation of the number of days a headache was present over each week


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male or female
  • age 18-65
  • meets International Classification Headache Disorders II (ICHD-II) criteria for post-traumatic headache
  • average pain score of greater than 4/10 in severity on the numerical rating system
  • Rancho Los Amigos cognitive scale score greater than seven.

Exclusion Criteria:

  • Uncontrolled medical condition other than PTH
  • Severe additional chronic pain complaint which could not be distinguished from headache pain
  • pregnancy, breast feeding,
  • prior treatment with botulinum toxin within one year of enrollment
  • current substance abuse/dependence
  • medical condition that would increase risk of neuromuscular junction blockade with botulinum toxin (myasthenia gravis, Eaton Lambert, amyotrophic lateral sclerosis)
  • poorly controlled psychiatric
  • initiation of a new anti-depressant or anti-seizure medication within three months of enrolling in study
  • ongoing disability or litigation claim.
Contacts and Locations

Locations
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United States, California
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073
Sponsors and Collaborators
VA Greater Los Angeles Healthcare System
Ipsen
Investigators
Layout table for investigator information
Principal Investigator: Milena Zirovich, MD VA Greater Los Angeles
Tracking Information
First Submitted Date  ICMJE April 18, 2019
First Posted Date  ICMJE April 26, 2019
Last Update Posted Date April 26, 2019
Actual Study Start Date  ICMJE August 1, 2013
Actual Primary Completion Date February 2, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2019) 		Incidence of headaches from baseline [ Time Frame: evaluation from time of injection until completion of 12 week follow-up ]
Evaluation in weekly incidence of headaches from baseline based on headache diary or weekly phone follow-up
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • Intensity of headache pain [ Time Frame: evaluation from time of injection until completion of 12 week follow-up ]
    Evaluation of pain intensity using score of headache on Numerical Rating Scale (NRS) over time. The NRS is an 11-point scale for patient self-reporting of pain with 0 being no pain and 10 being the most severe pain.
  • Number of headache days per week [ Time Frame: evaluation from time of injection until completion of 12 week follow-up ]
    Evaluation of the number of days a headache was present over each week
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Abobotulinumtoxina Efficacy in Post-Traumatic Headache
Official Title  ICMJE Abobotulinumtoxina Efficacy in Post-Traumatic Headache
Brief Summary This study will evaluate the efficacy of abobotulinumtoxina on Veterans with post-traumatic headache
Detailed Description

A significant proportion of headaches occur following head trauma, and therefore are referred to as post-traumatic headaches (PTH). Traumatic brain injury (TBI) is highly prevalent in the Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) population and consequently there has been a rise in PTH in the clinical setting at VA hospitals. Botulinum toxin type A (BoNT-A) has been shown to be effective in treating chronic migraine and chronic daily headache. It is therefore reasonable to predict that BoNT-A may also be effective in treating PTH. This study proposes that PTH and its associated symptoms may respond positively to BoNT-A treatment due to its similar pathophysiology and clinical resemblance to other headache disorders including tension type headache, typical migraine with or without aura, and chronic daily headache.

Study Design: Veterans with mild, moderate or severe brain injury with a headache developing within 7 days after head trauma and persisting greater than 3 months were recruited from the Veterans Affairs Greater Los Angeles Healthcare System. The study is a prospective, double-blind, randomized, placebo-controlled, cross-over trial.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description:
The project statistician used a computer-based random number generator to create a randomized treatment allocation schedule that was provided to the pharmacist and nurse practitioner who did not disclose this information. The pharmacist provided the nurse practitioner with the medication in an unlabeled bag, which either included BoNT-A or Normal Saline. Patients were randomized to receive BoNT-A or Normal Saline as first injection. The nurse practitioner reconstituted the medication in a separate room and then provided the investigator with unlabeled syringes.
Primary Purpose: Treatment
Condition  ICMJE Post-Traumatic Headache
Intervention  ICMJE
  • Drug: AbobotulinumtoxinA
    Subjects were injected with 0.1 ml (12.5 units of Abobotulinumtoxina) into 31 distinct muscle locations in the head and neck
    Other Name: Dysport
  • Drug: Normal saline
    Subjects were injected with 0.1 ml of preservative free normal saline into 31 distinct muscle locations in the head and neck
Study Arms  ICMJE
  • Experimental: Abobotulinumtoxina
    300 units of abobotulinumtoxinA was reconstituted with 2.4 ml of 0.9% preservative free sterile saline so that each 0.1 ml contained 12.5 units of Abobotulinumtoxina 0.1 ml were injected into 31 sites of the head and neck
    Intervention: Drug: AbobotulinumtoxinA
  • Placebo Comparator: Placebo
    0.9% preservative free sterile saline. 0.1 ml were injected into 31 sites of the head and neck
    Intervention: Drug: Normal saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2019) 		40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2, 2017
Actual Primary Completion Date February 2, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • male or female
  • age 18-65
  • meets International Classification Headache Disorders II (ICHD-II) criteria for post-traumatic headache
  • average pain score of greater than 4/10 in severity on the numerical rating system
  • Rancho Los Amigos cognitive scale score greater than seven.

Exclusion Criteria:

  • Uncontrolled medical condition other than PTH
  • Severe additional chronic pain complaint which could not be distinguished from headache pain
  • pregnancy, breast feeding,
  • prior treatment with botulinum toxin within one year of enrollment
  • current substance abuse/dependence
  • medical condition that would increase risk of neuromuscular junction blockade with botulinum toxin (myasthenia gravis, Eaton Lambert, amyotrophic lateral sclerosis)
  • poorly controlled psychiatric
  • initiation of a new anti-depressant or anti-seizure medication within three months of enrolling in study
  • ongoing disability or litigation claim.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03928496
Other Study ID Numbers  ICMJE Zirovich0002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: A de-identified dataset may be provided upon request
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Starting at 3 months following publication and up to 3 years after publication
Access Criteria: Data access requests will be reviewed and requestors will sign a data access agreement
Responsible Party VA Greater Los Angeles Healthcare System
Study Sponsor  ICMJE VA Greater Los Angeles Healthcare System
Collaborators  ICMJE Ipsen
Investigators  ICMJE
Principal Investigator: Milena Zirovich, MD VA Greater Los Angeles
PRS Account VA Greater Los Angeles Healthcare System
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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