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Completed

NCT Number: NCT02364453

The Effect of Histamine H1 Receptor Antagonist, Clemastin, on PACAP38 Induced Headache in Migraine Patients

The purpose of this study is to determine the effects of antihistamine (Clemastin) on migraines triggered by pituitary adenylate cyclase activating peptide-38 (PACAP38) as well as on biochemical markers for mast cell degranulation in migraine patients. Also, to investigate the occurrence of migraine in migraine patients after infusion of PACAP38 in lower dosages than previously investigated. As this has never been done before it is unknown how a lower dose of PACAP38 will affect 1) the incidence of migraine attacks, 2) the accompanying symptoms, 3) head pain characteristics, and 4) debut and duration of migraine attacks.

Our three hypotheses are:

1. Pre-treatment with Clemastin reduces PACAP38 sensitivity and inhibits development of migraine in migraine patients. 2. Clemastin inhibits the increase in plasma concentration of TNF-alpha, histamine and tryptase after PACAP38-infusion. 3. PACAP38 in lower dosages (4, 6 and 8 pmol/kg/min) induces migraine in migraine patients.

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Key information

Conditions

Migraine Without Aura Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Headache Center & Department of Neurology

Copenhagen, Glostrup, 2600, Denmark

About this study

The purpose of this study is to determine the effects of antihistamine (Clemastin) on migraines triggered by pituitary adenylate cyclase activating peptide-38 (PACAP38) as well as on biochemical markers for mast cell degranulation in migraine patients. Also, to investigate the occurrence of migraine in migraine patients after infusion of PACAP38 in lower dosages than previously investigated. As this has never been done before it is unknown how a lower dose of PACAP38 will affect 1) the incidence of migraine attacks, 2) the accompanying symptoms, 3) head pain characteristics, and 4) debut and duration of migraine attacks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • migraine patients fulfilling IHS criteria for migraine without aura, ages 18-50, 50-100 kg, fertile women must be using safe prevention

Exclusion criteria

  • other types of primary headache than migraine
  • headache on trial day or later than 48 hours before trial day
  • migraine up to three days before trial day
  • any type of cardiovascular disease
  • clinical signs or patient history of any type of illness that the medical doctor in charge of trials deems relevant for participation

Treatment and study plan

PACAP38

Drug

Giving doses of 4, 6 or 8 pg/kg/min on three separate trial days.

Other names: Pituitary Adenylate Cyclase Activating Peptide 38

Primary outcomes

  1. Development of migraine in migraine patients

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Song Guo

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 18, 2015
Registry last updated
Feb 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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