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

Migraine Without Aura Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02364453
• Other study ID #: H-4-2014-103
• Status: Completed
• Phase: N/A
• First received: October 7, 2014
• Last updated: February 13, 2018
• Start date: February 2015
• Est. completion date: April 2016

Study information

• Verified date: February 2018
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Without Aura

Intervention

Drug:
• PACAP38
Giving doses of 4, 6 or 8 pg/kg/min on three separate trial days.

Locations

Country	Name	City	State
Denmark	Danish Headache Center & Department of Neurology	Copenhagen	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Song Guo

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of migraine in migraine patients		Up to 12 months