Post-traumatic headache MedDRA version: 20.0 Level: LLT Classification code 10019222 Term: Headache post-traumatic System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Aimovig
Pharmaceutical Form:
Sponsors
Danish Headache Center
Eligibility
Sex/Gender
All
Inclusion 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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of ERENUMAB on change in the monthly average number of headache days with moderate or severe intensity from baseline to week 9-12 in patients with persistent post-traumatic headache (PPTH) To evaluate the effect of ERENUMAB on change in the monthly average number of headache days from baseline to week 9-12 in PPTH patients ;Secondary Objective: To evaluate the proportion of patients reaching at least 75% reduction in the monthly average number of headache days of any severity (Time frame: baseline – week 12) To evaluate the proportion of patients reaching at least 50% reduction in the monthly average number of headache days of any severity (i.e. responders) (Time frame: baseline – week 9-12) To evaluate the proportion of patients reaching at least 25% reduction in the monthly average number of headache days of any severity (Time frame: baseline – week 9-12) To evaluate the mean change in disability score, as measured by the 6-item Headache Impact Test (HIT-6) from baseline – week 12 To evaluate the mean change in number of days using acute medication from baseline – week 9-12 To evaluate the tolerability of erenumab. ;Primary end point(s): Change in the monthly average number of headache days with moderate or severe intensity from baseline to week 9-12 in patients with persistent post-traumatic headache (PPTH) Change in the monthly average number of headache days from baseline to week 9-12 in PPTH patients ;Timepoint(s) of evaluation of this end point: See above | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The proportion of patients reaching at least 75% reduction in the monthly average number of headache days of any severity (Time frame: baseline – week 12) The proportion of patients reaching at least 50% reduction in the monthly average number of headache days of any severity (i.e. responders) (Time frame: baseline – week 9-12) The proportion of patients reaching at least 25% reduction in the monthly average number of headache days of any severity (Time frame: baseline – week 9-12) The mean change in disability score, as measured by the 6-item Headache Impact Test (HIT-6) from baseline – week 12 The mean change in number of days using acute medication from baseline – week 9-12 ;Timepoint(s) of evaluation of this end point: See above | — |
Countries
Denmark
Contacts
Public ContactHenrik Schytz
Danish Headache Center
Outcome results
None listed