NL-OMON56199招募中3 期
Chronification Of migraine and Pain Experience - COPE study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients with chronic migraine with medication overuse:
- •i) age between 18 and 75 years;
- •ii) able to provide written informed consent;
- •iii) diagnosed with chronic migraine and medication overuse according to ICHD
- •3-beta criteria. ,
- •Patients with chronic migraine without medication overuse:
- •i) age between 18 and 75 years;
- •ii) able to provide written informed consent;
- •iii) diagnosed with chronic migraine according to ICHD 3-beta criteria. ,
- •Patients with episodic migraine:
- •i) age between 18 and 75 years;
- •ii) able to provide written informed consent;
- •iii) diagnosed with migraine with or without aura according to ICHD 3-beta
排除标准
- •Patients with chronic migraine with medication overuse:
- •i) Other primary or secondary headache syndromes except tension type headache
- •or medication overuse headache
- •Patients with chronic migraine without medication overuse:
- •i) Other primary or secondary headache syndromes except tension type headache
- •Patients with episodic migraine:
- •i) Other primary or secondary headache syndromes except tension type headache
- •(ii) A history of chronic migraine according to IHS 3-β criteria <1 year prior
- •to inclusion;
- •(iii) A history of medication overuse headache according to IHS 3-β criteria <1
- •year prior to inclusion.
- •General exclusion criteria:
- •(i) Neurological conditions, such as peripheral neuropathy or epilepsy, other
- •than the specific types described in the group specific inclusion criteria;
- •(ii) Any (chronic) pain condition of moderate to severe intensity, or requiring
- •pain medication, other than the types described in the group specific inclusion
- •(iii) Psychiatric disease, such as psychosis, other than mild to moderate
- •depression and anxiety, which in the opinion of the investigators may interfere
- •with the study;
- •(iv) Other medical disease such as pulmonary renal, liver, cardiac,
- •gastro-intestinal, vascular disease, which in the opinion of the investigators
- •may interfere with the study;
- •(v) Regular use of non-triptan or non-analgesic acute anti-headache medication
- •(e.g. ergots, high dose opioids (low dosages or sporadic/temporary users are
- •allowed), barbiturates) or high dose benzodiazepines;
- •(vi) Change in use of TCAs (a.o. amitriptyline high dosages (>40 mg/daily),
- •clomipramine, dosulepin, doxepin, imipramine, nortriptyline, maprotiline),
- •SNRIs (a.o. high dose duloxetine / venlafaxine, trazodone), or calcium channel
- •inhibitors (a.o. pregabalin, gabapentin) in the past three months.
- •(vii) Current abuse or history of abuse of alcohol, soft drugs or hard drugs,
- •which in the opinion of the investigators may interfere with the study;
- •(viii) Pregnancy or lactation;
- •(ix) Enrolment in other studies that may confound the results of this study.
研究者
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