Efficacy and Tolerability of Erenumab in the Prophylactic Treatment of Persistent Post-Traumatic … (NCT03974360) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Tolerability of Erenumab in the Prophylactic Treatment of Persistent Post-Traumatic Headache
Denmark100 participantsStarted 2019-04-05
Plain-language summary
An exploratory open-label study of PPTH patients to study the efficacy and tolerability of erenumab in the prophylactic treatment of persistent headache attributed to mild traumatic injury to the head. Approximately 100 subjects will be included to erenumab 140 mg. Patients who have participated in study with prior provocation (Ethics Committee of the Capital Region of Denmark (H-1801147 and H-18050498) and who have consented to be contacted will primarily be included. The study will begin February 2019 and is expected to last one year. Patients responding to advertisement (see add) will be contacted by phone.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men and women between 18 - 65 years who suffer from PPTH following a concussion / mild traumatic brain injury more than 12 months ago.
* Fertile women must use safe contraceptives and present with a negative u-HCG on the experimental day. Safe contraceptives are defined as intra-uterine devices, contraceptive pills or implants and surgical sterilization.
Exclusion Criteria:
* Pre-trauma primary headache disorders, including tension-type headache \> 1 days/months
* Medication-overuse headache
* Whiplash injury
* Cardiovascular disease of any kind, including cerebrovascular disease
* Hypertension on the experimental day (systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 100 mmHg)
* Hypotension on the experimental day (systolic blood pressure \< 90 mmHg and/or diastolic blood pressure \< 50 mmHg)
* Pre-trauma psychiatric disorder of any kind - unless effectively treated
* Anamnestic or clinical symptoms of any kind that are deemed relevant for study participation by the physician who examines the patient
* Pregnant or breastfeeding, or is a female expecting to conceive during the study,
* including through 4 weeks after the last dose of erenumab
* Female subject of childbearing potential who is unwilling to use an acceptable
* Method of effective contraception during treatment through 4 weeks after the last dose of erenumab. Acceptable methods of effective birth control include not having intercourse (true abstinence, when this is in…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested erenumab specifically for headache after mild traumatic brain injury or concussion — how does my own headache situation compare to the patients who were enrolled, and is erenumab something worth considering in my case?
2Since this was a Phase 2 trial, what does that mean for how confident we can be about erenumab's safety and effectiveness for post-traumatic headache specifically, compared to its already-approved use for other headache types?
3The trial focused on reducing headache days with moderate or severe intensity — based on how often and how badly my headaches affect me, would I have fit the profile of patients in this study, and does that change your thinking about my treatment options?
4Now that this trial is completed, are there published results we can look at together, and do those results suggest erenumab worked well enough that it might be a reasonable option to try for me?
5Before considering something like erenumab, are there standard or more established treatments for post-traumatic headache or post-concussion syndrome that I should try first, and how would we know if this newer approach makes more sense for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effect of Erenumab on Headache Days with Moderate or Severe Intensity