Prostaglandin E2 in Migraine Suffers Without Aura.

NCT ID: NCT01384812

Last Updated: 2011-11-09

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-07-31

Brief Summary

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

The hypothesis of this study is that Prostaglandin E2 (PGE2) induces headache and dilatation of brain vessels in migraine patients without aura.

Detailed Description

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

Conditions

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

"Migraine-like" Headache

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

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

Isoton sodium chloride

Group Type PLACEBO_COMPARATOR

isoton sodium chloride

Intervention Type DRUG

intravenous injection for 25 min

Prostin E2 (dinoprostone)

Group Type ACTIVE_COMPARATOR

dinoprostone

Intervention Type DRUG

intravenous injection 0.4 μgr/kg/min for 25 min

Interventions

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

dinoprostone

intravenous injection 0.4 μgr/kg/min for 25 min

Intervention Type DRUG

isoton sodium chloride

intravenous injection for 25 min

Intervention Type DRUG

Other Intervention Names

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

Prostin E2 placebo

Eligibility Criteria

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

Inclusion Criteria

* Patients with migraine without aura

Exclusion Criteria

* Tension type headache more than x 3 per month
* Other forms for primary headache
* Headache 24 h before the day of the investigation
* Migraine 48 h before the day of the investigation
* Hypertension
* Hypotension
* Pregnant/nursing
* Daily intake of medication (except oral contraceptives and migraine rescue medicine during migraine attack)
* Cardiovascular or central nervous system (CNS) disease
* Drug/alcohol abuse
* Psychiatric disease
* Asthma or any other lung diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Troels Wienecke

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Troels Wienecke

MD,PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Troels Wienecke, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Danish Headache Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Danish Headache Center

Glostrup Municipality, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DHC-PGE2-2011

Identifier Type: -

Identifier Source: org_study_id