PACAP27 Headache Properties in Migraine Without Aura Patients

NCT03471039 | Completed

• 1 other identifier: H-17016232
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine Without Aura

Outcome Measures

Primary Outcomes (1)

• Headache Scores

  Comparison between PACAP27 and Placebo

  0-12 hours

Secondary Outcomes (1)

• Facial blood flow (flushing)

  0-120 mins

Study Arms (2)

Active

ACTIVE COMPARATOR

PACAP-27

Drug: PACAP27

Placebo

PLACEBO COMPARATOR

Saline

Drug: Saline

Interventions

PACAP27 DRUG

Infusion of PACAP27 over 20 minutes.

Active

Saline DRUG

Infusion of Saline over 20 minutes.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Center

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

Migraine without Aura

Interventions

Pituitary Adenylate Cyclase-Activating Polypeptide; Sodium Chloride

Condition Hierarchy (Ancestors)

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Nerve Growth Factors; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Neuropeptides; Proteins; Nerve Tissue Proteins; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 20, 2018
• Study Start: August 30, 2017
• Primary Completion: August 30, 2018
• Study Completion: September 30, 2018
• Last Updated: January 24, 2019

Record last verified: 2019-01

Locations

DK (1)