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

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ClinicalTrials.gov Identifier: NCT02364453
Recruitment Status : Completed
First Posted : February 18, 2015
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Song Guo, Danish Headache Center

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Migraine Without Aura Drug: PACAP38 Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Histamine H1 Receptor Antagonist, Clemastin, on PACAP38 Induced Headache in Migraine Patients
Study Start Date : February 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: Placebo to PACAP38
Pre-treatment with placebo. PACAP38 8pmol/kg/min
Drug: PACAP38
Giving doses of 4, 6 or 8 pg/kg/min on three separate trial days.
Other Name: Pituitary Adenylate Cyclase Activating Peptide 38

Experimental: Clemastin 1 mg/ml to PACAP38 8pmol/kg/min
Pre-treatment with Clemastin 1 mg/ml PACAP38 8 pmol/kg/min
Drug: PACAP38
Giving doses of 4, 6 or 8 pg/kg/min on three separate trial days.
Other Name: Pituitary Adenylate Cyclase Activating Peptide 38




Primary Outcome Measures :
  1. Development of migraine in migraine patients [ Time Frame: Up to 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02364453


Locations
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Denmark
Danish Headache Center & Department of Neurology
Copenhagen, Glostrup, Denmark, 2600
Sponsors and Collaborators
Song Guo
Investigators
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Study Director: Messoud Ashina, Professor Danish Headache Center

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Responsible Party: Song Guo, Medical Doctor, PhD.-student, Danish Headache Center
ClinicalTrials.gov Identifier: NCT02364453     History of Changes
Other Study ID Numbers: H-4-2014-103
First Posted: February 18, 2015    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
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Migraine Disorders
Migraine without Aura
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Histamine
Histamine phosphate
Pituitary Adenylate Cyclase-Activating Polypeptide
Histamine H1 Antagonists
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Growth Substances
Vasodilator Agents
Histamine Antagonists