NCT03974360已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Effect of Erenumab on Headache Days with Moderate or Severe Intensity
研究概览
简要总结
An exploratory open-label study of PPTH patients to study the efficacy and tolerability of erenumab in the prophylactic treatment of persistent headache attributed to mild traumatic injury to the head. Approximately 100 subjects will be included to erenumab 140 mg. Patients who have participated in study with prior provocation (Ethics Committee of the Capital Region of Denmark (H-1801147 and H-18050498) and who have consented to be contacted will primarily be included. The study will begin February 2019 and is expected to last one year. Patients responding to advertisement (see add) will be contacted by phone.
详细描述
The reasons and justification of choosing an open-label design are the following:
- To date, there are no evidence for prophylactic drugs treating post-traumatic headache. Post-traumatic headache patients are notoriously known to be refractory to prophylactic treatment and have usually tried several prophylactic drugs such as amitriptylin, which is recommended as a prophylactic drug in migraine and chronic tension-type headache, and other drugs developed for the treatment of primary headache disorders. First step is therefore to show if there is an effect at all following erenumab treatment in these refractory PPTH patients.
- The refractory nature of PPTH will lower the bias that could occur through placebo effects.
- The treatment period is also quite long, and the endpoint is assessed in the last month of treatment, which will also minimize a placebo effect.
- Furthermore, this relatively small exploratory open label study is needed to show if there is an effect of erenumab in post-traumatic headache at all and what this effect is, before initiating larger multicenter double-blind studies in this patient group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Erenumab
Experimental
100 subjects with persistent post-traumatic headache will be allocated to receive monthly subcutaneous injections of 140 mg erenumab at three time points (week 0, week 4, week 8)
干预措施: AMG 334 (Drug)
结局指标
主要结局
Effect of Erenumab on Headache Days with Moderate or Severe Intensity
时间窗: 12 weeks
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). The assessment will be made using a headache diary.
次要结局
- Proportion of Patient reaching at least 50% reduction in monthly average number of headache days(12 weeks)
- Proportion of Patient reaching at least 25% reduction in monthly average number of headache days(12 weeks)
- Erenumab on number of Headache Days(12 weeks)
- Proportion of Patient reaching at least 75% reduction in monthly average number of headache days(12 weeks)
- Tolerability of Erenumab will be assessed by recording number and type of adverse events(12 weeks)
- Headache Impact Test (HIT-6)(12 weeks)
研究者
Henrik Schytz
Associate Professor
Danish Headache Center
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
Efficacy and Tolerability of Erenumab in the Management of Persistent Redness and Flushing in RosaceaRosaceaNCT04419259Messoud Ashina30
已完成
2 期
A Study to Assess the Long-term Safety and Efficacy of Erenumab (AMG 334) in Chronic Migraine Prevention.Treatment for Prevention of Chronic MigraineNCT02174861Amgen609
已完成
4 期
A Study to Evaluate Treatment Satisfaction With Erenumab in Participants With MigraineMigraineNCT04825678Amgen240
Unknown
2 期
Etanercept (Enbrel) in Undifferentiated SpondyloarthritisSpondyloarthritisNCT01289730Charite University, Berlin, Germany8
撤回
1 期
Study of Intravenous Erenumab in Patients With Status MigrainosusStatus MigrainosusNCT04920331Mayo Clinic