Migraine Without Aura
Conditions
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.
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.
Interventions
DRUGPACAP38
Giving doses of 4, 6 or 8 pg/kg/min on three separate trial days.
Sponsors
Song Guo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Development of migraine in migraine patients | Up to 12 months |
Countries
Denmark
Outcome results
None listed