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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Assess the Efficacy and Safety of Oral CL-H1T in the Treatment of Acute Migraine Pain

NCT03877718

Migraine Pain Nausea +2 more

COMPLETED PHASE2

PACAP38 Induced Headache, Migraine and Flushing in Patients With Migraine

NCT03881644

Migraine Without Aura

COMPLETED NA

PACAP38´s (Pituitary Adenylate Cyclase-Activating Polypeptide) Headache Inducing Characteristics and Effects on the Cerebral Blood Flow

NCT00380263

Migraine Without Aura

COMPLETED NA

Hypersensitivity to PACAP-38 in Post-Traumatic Headache

NCT05378061

Post-Traumatic Headache

UNKNOWN NA

PACAP-38 Infusion in Patients With Cluster Headache

NCT03814226

Cluster Headache

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Migraine Without Aura

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo to PACAP38

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

Group Type EXPERIMENTAL

PACAP38

Intervention Type DRUG

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

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

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

Group Type EXPERIMENTAL

PACAP38

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PACAP38

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Pituitary Adenylate Cyclase Activating Peptide 38

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No