Trials / Completed
CompletedNCT02364453
The Effect of Histamine H1 Receptor Antagonist, Clemastin, on PACAP38 Induced Headache in Migraine Patients
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Song Guo · Academic / Other
- Sex
- All
- Age
- 20 Years – 50 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PACAP38 | Giving doses of 4, 6 or 8 pg/kg/min on three separate trial days. |
Timeline
- Start date
- 2015-02-01
- Primary completion
- 2016-04-01
- Completion
- 2016-04-01
- First posted
- 2015-02-18
- Last updated
- 2018-02-15
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT02364453. Inclusion in this directory is not an endorsement.