PACAP27 Headache Properties in Migraine Without Aura Patients

Migraine Without Aura Clinical Trial

Official title:

Pituitary Adenylate Cyclase-activating Polypeptide (PACAP27) Headache Properties in Migraine Without Aura Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03471039
• Other study ID #: H-17016232
• Status: Completed
• Phase: N/A
• Start date: August 30, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: January 2019
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pituitary adenylate cyclase-activating polypeptide (PACAP) is a signaling molecule, localized in sensory and parasympathetic perivascular nerves fibres. PACAP exists i to functional iso-forms Pituitary adenylate cyclase-activating polypeptide-38 (PACAP38) and PACAP27.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 30, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Migraine patients meeting International Headache Society (IHS) criteria for migraine without aura of both sexes, 18-60 year, 50-100 kg.

• Fertile women should use safe contraception. Fertile women do not include hysterectomized women or women who are postmenopausal for at least 2 years. Safe contraception includes either Intra Uterine Device (IUD), birth control pills, surgical sterilization of the woman or depot progestogen.

Exclusion Criteria:

• Tension Type headache for more than 5 days the month on average in the last year.

• All other primary headaches .

• Headache later than 48 hours before trial start.

• Daily intake of any medicine other than oral contraception.

• Ingestion of any form of medicinal product later than 4 times the plasma half-life substance (on trial day), except for oral contraception.

• Pregnant or breastfeeding women.

• Headache on the test day or later than 48 hours prior to administration of trial medicine / placebo

• Migraine within 5 days before the trial date.

• Ancestral information or clinical signs of (on the day of inclusion):

• Hypertension (systolic blood pressure> 150 mmHg and / or diastolic blood pressure> 100 mmHg)

• Hypotension (systolic blood pressure <90 mm Hg and / or diastolic blood pressure <50 mmHg)

• Cardiovascular disease of all kinds, including cerebrovascular disease.

• Anamnestic or clinical signs of mental illness or abuse.

• Patients with glaucoma or prostatic hyperplasia

• Anamnestic or clinical signs of diseases of any kind such as the investigating physician is considered relevant for participation in the trial.

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Without Aura

Intervention

Drug:
• PACAP27
Infusion of PACAP27 over 20 minutes.
• Saline
Infusion of Saline over 20 minutes.

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache Scores	Comparison between PACAP27 and Placebo	0-12 hours
Secondary	Facial blood flow (flushing)	PACAP27 induces facial flushing compare to placebo measured by laser speckle contrast imaging	0-120 mins