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Abobotulinumtoxina Efficacy in Post-Traumatic Headache

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: NCT03928496
Recruitment Status : Completed
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
Ipsen
Information provided by (Responsible Party):
VA Greater Los Angeles Healthcare System

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.


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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Headache

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




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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928496


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
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Principal Investigator: Milena Zirovich, MD VA Greater Los Angeles

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Responsible Party: VA Greater Los Angeles Healthcare System
ClinicalTrials.gov Identifier: NCT03928496     History of Changes
Other Study ID Numbers: Zirovich0002
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A de-identified dataset may be provided upon request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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

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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

Additional relevant MeSH terms:
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Headache
Post-Traumatic Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
abobotulinumtoxinA
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents