Last updated on February 2020

Efficacy and Tolerability of Erenumab in the Prophylactic Treatment of Persistent Post-Traumatic Headache

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Post-Traumatic Headache | Mild Traumatic Brain Injury | Post-concussional syndrome
  • Age: Between 18 - 65 Years
  • Gender: Male or Female

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 line with the preferred and usual lifestyle of the subject), hormonal birth control methods (pills, shots/injections, implants, or patches), intrauterine devices, surgical contraceptive methods (vasectomy with medical assessment of the surgical success of this procedure or bilateral tubal ligation), or two barrier methods (each partner must use one barrier method) with spermicide - males must use a condom with spermicide; females must choose either a diaphragm with spermicide, OR cervical cap with spermicide, OR contraceptive sponge with spermicide. Female subjects not of childbearing potential are defined as any female who: is post-menopausal by history, defined as:
  • Age 55 years with cessation of menses for 12 or more months, OR
  • Age < 55 years but no spontaneous menses for at least 2 years, OR
  • Age < 55 years and spontaneous menses within the past 1 year, but currently amenorrheic (eg, spontaneous or secondary to hysterectomy), AND with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone levels > 40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) or according to the definition of "postmenopausal range" for the laboratory involved. OR
  • Underwent bilateral oophorectomy OR
  • Underwent hysterectomy OR
  • Underwent bilateral salpingectomy
  • Known sensitivity to any component of erenumab
  • Previously randomized into an erenumab study
  • Member of investigational site staff or relative of the investigator
  • Unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures to the best of the subject's and investigator's knowledge

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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