MedPath

Chronification Of migraine and Pain Experience

Phase 3
Recruiting
Conditions
migraine
10019231
headache
Registration Number
NL-OMON56199
Lead Sponsor
eids Universitair Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
120
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

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
criteria;
(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.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Part A and part B<br /><br>Primary outcome measurements for of the three aspects:<br /><br>i) relative change in peak VAS score;<br /><br>ii) QST parameters;<br /><br>iii) corneal nerve fiber density.<br /><br><br /><br>& Headache frequency</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Part A and B<br /><br>Secondary outcomes for each of the three aspects:<br /><br>i) change in area under the curve (VAS*sec) of the test stimulus during the<br /><br>conditioned stimulus;<br /><br>ii) no additional outcomes;<br /><br>iii) corneal nerve fiber length and corneal nerve branch density.<br /><br><br /><br>Additional outcome measures:<br /><br>- Sum scores on depression, anxiety and visual sensitivity questionnaires. </p><br>
© Copyright 2025. All Rights Reserved by MedPath