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OpenTrials
Completed

NCT Number: NCT03471039

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Headache Center

Glostrup Municipality, 2600, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PACAP27

Drug

Infusion of PACAP27 over 20 minutes.

Saline

Drug

Infusion of Saline over 20 minutes.

Primary outcomes

  1. Headache Scores

    Time frame: 0-12 hours

    Comparison between PACAP27 and Placebo

Secondary outcomes

  1. Facial blood flow (flushing)

    Time frame: 0-120 mins

    PACAP27 induces facial flushing compare to placebo measured by laser speckle contrast imaging

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 20, 2018
Registry last updated
Jan 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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