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Chronification Of migraine and Pain Experience

Chronification Of migraine and Pain Experience - COPE study

Status
Recruiting
Phases
Phase 3
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56199
Enrollment
120
Registered
2017-07-25
Start date
2018-07-24
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

headache migraine

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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 criteria;

Exclusion criteria

Exclusion criteria: 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 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.

Design outcomes

Primary

MeasureTime frame
Part A and part B Primary outcome measurements for of the three aspects: i) relative change in peak VAS score; ii) QST parameters; iii) corneal nerve fiber density. & Headache frequency

Secondary

MeasureTime frame
Part A and B Secondary outcomes for each of the three aspects: i) change in area under the curve (VAS*sec) of the test stimulus during the conditioned stimulus; ii) no additional outcomes; iii) corneal nerve fiber length and corneal nerve branch density. Additional outcome measures: - Sum scores on depression, anxiety and visual sensitivity questionnaires.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)