PACAP27 Headache Properties in Migraine Without Aura Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Migraine Without Aura
• Intervention / Treatment: Drug: PACAP27; Drug: Saline

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Glostrup, Denmark, 2600
    • Danish Headache Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active; PACAP-27	Drug: PACAP27; Infusion of PACAP27 over 20 minutes.
Placebo Comparator: Placebo; Saline	Drug: Saline; Infusion of Saline over 20 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache Scores	Comparison between PACAP27 and Placebo	0-12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Facial blood flow (flushing)	PACAP27 induces facial flushing compare to placebo measured by laser speckle contrast imaging	0-120 mins

Collaborators and Investigators

• Sponsor: Danish Headache Center

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2017
• Primary Completion (Actual): August 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: March 13, 2018
• First Posted (Actual): March 20, 2018

Study Record Updates

• Last Update Posted (Actual): January 24, 2019
• Last Update Submitted That Met QC Criteria: January 23, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache; Migraine without Aura; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Growth Substances; Pituitary Adenylate Cyclase-Activating Polypeptide
• Other Study ID Numbers: H-17016232

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No