Biological characterization of a tension-type headache

Phase 1

• Conditions: Tension-type headache; MedDRA version: 19.0Level: PTClassification code 10043269Term: Tension headacheSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2016-003846-97-DK
• Lead Sponsor: Section of Orofacial Pain and Jaw Function, Aarhus University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-19
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

TTH participants:
•Patients must fulfill the ICHD-3 criteria for either FETTH or CTTH
•Taking or will be taking mirtazapine for prophylaxis of TTH
•Between 18 and 65 years of age
•Fertile women must use adequate contraception (oral contraceptive pills, intrauterine devices or birth control implant)
•Participants must agree to participate in the study and sign informed consent
Healthy participants
•Between 18 and 65 years of age
•Fertile women must use adequate contraception (oral contraceptive pills, intrauterine devices or birth control implant)
•Participants must agree to participate in the study and sign informed consent

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 108
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•No psychiatric or major medical conditions currently or in the past 12 months
•No concurrent headache, pain symptoms or diagnoses other than that of TTH
•Diagnosis of cancer presently or in the past 5 years
•Abuse of drugs including alcohol
•Diagnosis of Raynaud’s phenomenon
•Having gone through a sympathectomy procedure
•Diagnosis of cardiovascular disease
•Diagnosis of lung insufficiency, including bronchial asthma
•Diagnosis of diabetes mellitus
•Pregnancy
•Lactation
•Students who are currently taught by any of the people related to the project
•Participants who cannot follow the study protocol
•Participants who do not agree to comply with the requirements for participation in all sessions concerning times, food intake and physical activity.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To characterize a population of tension-type headache patients by means of phenotyping and genotyping into different groups that would facilitate the selection of adequate treatment for each individual patient.;Secondary Objective: 1 - To assess if the response to treatment with mirtazapine of TTH<br>patients can be predicted by conditioned pain modulation.<br>2- To investigate the expression of NO, TNF-a, IL-1ß, IL-6 and ß2- and<br>ß3-adrenergic receptors in nerve fibers of muscles of Tension-type<br>headache patients and controls.;Primary end point(s): The primary efficacy variables are number of headache days, severity of<br>headache (on a 0-10 scale attack where where 0 is no pain/discomfort<br>and 10 is the worst pain/discomfort) and amount of rescue medication<br>taken.;Timepoint(s) of evaluation of this end point: At baseline, 1 month after baseline and 2 months after baseline.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary variables are a modified total tenderness score (TTS) (0 to 100 scale with 0 being no sensation whatsoever, 1 to 49 being<br>sensation of pressure but the stimulus is not painful, 50 being barely painful and 100 being the most painful imaginable), Quantitative sensory testing scores (QST), changes in PPTs during the conditioned pain modulation (CPM) paradigm, amount of expression of NO, TNF-a, IL-1ß, IL-6 and ß2- and ß3-adrenergic receptors in nerve fibers of the assessed muscles and autonomic nervous system (ANS) variables such as heart rate variability.;Timepoint(s) of evaluation of this end point: TTS, QST, CPM and ANS parameters will be assessed at baseline, 1<br>month after baseline and 2 months after baseline.<br>Assessment of expression of NO, TNF-a, IL-1ß, IL-6 and ß2- and ß3-<br>adrenergic receptors in nerve fibers of the assessed muscles will be done<br>at baseline and 2 months after baseline.