EUCTR2018-003943-46-DK
Active, not recruiting
Phase 1
An open label study to evaluate the efficacy and tolerability of erenumab in the prophylactic treatment of persistent headache attributed to mild traumatic injury to the head - STOP study
ConditionsPost-traumatic headacheMedDRA version: 20.0Level: LLTClassification code 10019222Term: Headache post-traumaticSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsAimovig
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Post-traumatic headache
- Sponsor
- Danish Headache Center
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
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
Outcomes
Primary Outcomes
Not specified
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