PACAP27 Headache Properties in Migraine Without Aura Patients

Not Applicable

Completed

• Conditions: Migraine Without Aura
• Interventions: Drug: PACAP27; Drug: Saline

• Registration Number: NCT03471039
• Lead Sponsor: Danish Headache Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-30
• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-03-13
• Study First Posted: 2018-03-20
• Primary Completion: 2018-08-30
• Study Completion: 2018-09-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-23
• Last Update Posted: 2019-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active	PACAP27	PACAP-27
Placebo	Saline	Saline

Primary Outcome Measures

Name	Time	Method
Headache Scores	0-12 hours	Comparison between PACAP27 and Placebo

Secondary Outcome Measures

Name	Time	Method
Facial blood flow (flushing)	0-120 mins	PACAP27 induces facial flushing compare to placebo measured by laser speckle contrast imaging

Trial Locations

Locations (1)

Danish Headache Center; 🇩🇰 Glostrup, Denmark