EUCTR2018-003943-46-DKActive, not recruitingPhase 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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Danish Headache Center
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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
Investigators
Similar Trials
Active, not recruiting
Phase 1
An open label study to evaluate the efficacy and tolerability of erenumab in the management of persistent redness and flushing in rosacea - STOP ROS StudyEUCTR2019-003971-20-DKRigshospitalet Glostrup30
Active, not recruiting
Phase 1
A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple SclerosisRelapsing remitting multiple sclerosis (RRMS)MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.1Level: LLTClassification code 10039720Term: Sclerosis multipleSystem Organ Class: 10029205 - Nervous system disordersEUCTR2015-005597-38-DKF. Hoffmann-La Roche Ltd680
Active, not recruiting
Phase 1
A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple SclerosisRelapsing remitting multiple sclerosis (RRMS)MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.1Level: LLTClassification code 10039720Term: Sclerosis multipleSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2015-005597-38-ITF. HOFFMANN - LA ROCHE LTD.680
Active, not recruiting
Phase 1
A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple SclerosisRelapsing remitting multiple sclerosis (RRMS)MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.1Level: LLTClassification code 10039720Term: Sclerosis multipleSystem Organ Class: 10029205 - Nervous system disordersEUCTR2015-005597-38-IEF. Hoffmann-La Roche Ltd680
Active, not recruiting
Phase 1
A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple SclerosisRelapsing remitting multiple sclerosis (RRMS)MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.1Level: LLTClassification code 10039720Term: Sclerosis multipleSystem Organ Class: 10029205 - Nervous system disordersEUCTR2015-005597-38-FIF. Hoffmann-La Roche Ltd680