Headache Clinical Trial
Official title:
A Randomized Controlled Trial of Medical Therapies for Chronic Post-Traumatic Headaches
To determine if propranolol, amitriptyline, or topiramate decreases headache frequency in patients with chronic post-traumatic headaches.
A total of 240 patients meeting International Classification of Headache Disorders (ICHD)
diagnostic criteria for chronic post-traumatic headaches will be enrolled. Subjects will be
recruited from the Neurology Clinic at Madigan Army Medical Center. Study participants will
be U.S. Army soldiers who sustained a mild traumatic head injury while deployed to a combat
theater resulting in chronic post-traumatic headaches. Subjects will be randomized to
placebo, propranolol (target dose 80 mg a day), amitriptyline (target dose 50 mg a day), or
topiramate (target dose 100 mg a day) for 3 months.
The primary outcome measure will be the mean number of headache days per month on the third
month of treatment. Secondary outcome measures will include the proportion of subjects with
at least a 25% reduction in headache frequency, headache severity (0-10 scale), headache
duration (hours), headache-related disability (measured by the Headache Impact Test and
Migraine Disability Assessment Scale), PTSD symptom checklist score, and medication side
effects and tolerability.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03472872 -
A Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache
|
Phase 4 | |
| Withdrawn |
NCT05410366 -
Safe Harbors in Emergency Medicine, Specific Aim 3
|
||
| Withdrawn |
NCT02866084 -
Neuromodulation Treatment of Vestibular Migraines
|
N/A | |
| Active, not recruiting |
NCT03537573 -
Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Pain in Primary Care
|
N/A | |
| Recruiting |
NCT05891808 -
miR-155 Expression in Episodic and Chronic Migraine
|
||
| Not yet recruiting |
NCT04352218 -
Safety Profile of PETALO CVS in the Treatment of Non-thrombotic Internal Jugular Vein Stenosis and Chronic Headache
|
Phase 2 | |
| Completed |
NCT02734992 -
Acceptance and Commitment Therapy vs Medical Treatment as Usual Wait-list Control for Primary Headache Sufferers
|
N/A | |
| Completed |
NCT01327118 -
Prostaglandin F2alpha in a Human Headache Model
|
N/A | |
| Completed |
NCT01153789 -
Study of Oculomotor Dysfunction Leading to Children Vertigo
|
N/A | |
| Not yet recruiting |
NCT00969995 -
Identification of Inflammatory Markers in Migraine Patients
|
N/A | |
| Not yet recruiting |
NCT00752921 -
Randomized Placebo Controlled Trial With Etoricoxib That is Taken to Prevent the Yom Kippur Headache
|
Phase 4 | |
| Completed |
NCT00212810 -
Evaluation of the Effectiveness of Topiramate in Preventing the Transformation From Episodic Migraine to Chronic Daily Headache.
|
Phase 4 | |
| Terminated |
NCT00291395 -
PGI2 Induced Headache and Cerebral Haemodynamics in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT00263094 -
An End to the Yom Kippur (and Ramadan) Headache
|
N/A | |
| Completed |
NCT00135122 -
Prednisolone in the Treatment of Withdrawal Headache in Probable Medication Overuse Headache
|
Phase 3 | |
| Completed |
NCT02475005 -
An Intervention to Improve Adolescent Headache Self-management
|
N/A | |
| Completed |
NCT03163901 -
The Effect of OMT on Functional Outcomes and Anti-inflammatory Biomarkers in Mild to Moderate Traumatic Brain Injury
|
N/A | |
| Completed |
NCT01664585 -
Exercise Training With Physically Active Lifestyle to Reduce Headache and Quality of Life
|
N/A | |
| Completed |
NCT04632420 -
Evaluation of Headache and Childbirth in a Chronic Pain Population
|
||
| Recruiting |
NCT05033613 -
Home Blood Pressure Monitoring Before and After COVID-19 Vaccination in Patients at High Risk of Cardiovascular Disease
|