Status:
WITHDRAWN
Study of Gammacore Sapphire for the Acute and Preventive Treatment of Post-Traumatic Headache (GAP-PTH)
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
ElectroCore INC
Conditions:
Post-Traumatic Headache
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this single-center, prospective, randomized, double-blind, sham controlled, parallel-group study is to collect clinical data related to the safety and efficacy of vagus nerve stimulatio...
Detailed Description
The study will enroll 60 subjects over a period of 14 weeks each. Subjects will use either a sham or active device to treat acute Post Traumatic Headache. Investigators will collect clinical data rela...
Eligibility Criteria
Inclusion
- Meets the ICHD-3 criteria for acute headache attributed to mild traumatic injury to the head
- Experiences a minimum of 2 headaches (migraine or probable migraine phenotype) per week
- Presentation to clinic between 2 and 4 weeks after injury
- Able to provide written informed consent
Exclusion
- Any pre-existing primary headache disorder (with the exception of infrequent episodic tension type headache)
- Any contraindication to using nVNS
- Initiation or change in the dosage of any medication commonly used or headache prophylaxis 3 months before enrollment into the study
- Continuous headache at the time of enrollment
- PTH \>4 weeks after injury
- Structural abnormality at the nVNS treatment site (e.g., lymphadenopathy, previous surgery, abnormal anatomy)
- Pain at the nVNS treatment site (e.g., dysesthesia, neuralgia, cervicalgia)
- Other significant pain problem (e.g., cancer pain, fibromyalgia, other head or facial pain disorder) that, in the opinion of the Investigator, may confound the study assessments
- Known or suspected severe cardiac disease (e.g., symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure) or an abnormal baseline electrocardiogram (ECG) within the last year (e.g., second- or third-degree heart block, prolonged QT interval, atrial fibrillation, atrial flutter, history of ventricular tachycardia or ventricular fibrillation, clinically significant premature ventricular contraction)
- Known or suspected cerebrovascular disease (e.g., prior stroke or transient ischemic attack, symptomatic carotid artery disease, prior carotid endarterectomy or other vascular neck surgery)
- Previous cervical vagotomy
- A relative of or an employee of the Investigator or the clinical study site
- Previously used gammaCore
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04071743
Start Date
January 1 2020
End Date
December 31 2021
Last Update
March 10 2020
Active Locations (1)
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1
UT Southwestern Medical Center Dallas
Dallas, Texas, United States, 75390-9044