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PACAP27 Headache Properties in Migraine Without Aura Patients

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ClinicalTrials.gov Identifier: NCT03471039
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Hashmat Ghanizada, 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.

Condition or disease Intervention/treatment Phase
Migraine Without Aura Drug: PACAP27 Drug: Saline Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: Pituitary Adenylate Cyclase-activating Polypeptide (PACAP27) Headache Properties in Migraine Without Aura Patients
Actual Study Start Date : August 30, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

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.




Primary Outcome Measures :
  1. Headache Scores [ Time Frame: 0-12 hours ]
    Comparison between PACAP27 and Placebo


Secondary Outcome Measures :
  1. Facial blood flow (flushing) [ Time Frame: 0-120 mins ]
    PACAP27 induces facial flushing compare to placebo measured by laser speckle contrast imaging



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471039


Contacts
Contact: Hashmat Ghanizada, MD 0045-51447278 hashmat.ghanizada@regionh.dk

Locations
Denmark
Danish Headache Center Recruiting
Glostrup, Denmark, 2600
Contact: Hashmat Ghanizada, MD    0045-51447278    hashmat.ghanizada@regionh.dk   
Sponsors and Collaborators
Danish Headache Center

Responsible Party: Hashmat Ghanizada, Principal Investigator, Danish Headache Center
ClinicalTrials.gov Identifier: NCT03471039     History of Changes
Other Study ID Numbers: H-17016232
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Migraine Disorders
Migraine without Aura
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Pituitary Adenylate Cyclase-Activating Polypeptide
Growth Substances
Physiological Effects of Drugs
Vasodilator Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action