Investigation on the effect and tolerability of erenumab in posttraumatic headache
- Conditions
- Post-traumatic headacheMedDRA version: 20.0Level: LLTClassification code 10019222Term: Headache post-traumaticSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2018-003943-46-DK
- Lead Sponsor
- Danish Headache Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 100
Men and women between 18 – 65 years who suffer from PPTH following a concussion / mild traumatic brain injury
Fertile women must use safe contraceptives or 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 o Underwent bilateral oophorectomy OR o Underwent hysterectomy OR o 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method