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

Song Guo

Status: Completed

Conditions: Migraine Without Aura

Treatments: Drug: PACAP38

Study type: Interventional

Funder types: Other

Identifiers

NCT02364453

H-4-2014-103

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Placebo to PACAP38

Experimental group

Description:

Pre-treatment with placebo. PACAP38 8pmol/kg/min

Treatment:

Drug: PACAP38

Clemastin 1 mg/ml to PACAP38 8pmol/kg/min

Experimental group

Description:

Pre-treatment with Clemastin 1 mg/ml PACAP38 8 pmol/kg/min

Treatment:

Drug: PACAP38