Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

PACAP38 Induced Headache and Rosacea-like Symptoms in Patients With Rosacea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03878784
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Nita Katarina Frifelt Wienholtz, Danish Headache Center

Brief Summary:
The investigators aim is to investigate the incidence of headache and rosacea-like flushing after pituitary adenylate cyclase-activating peptide-38 (PACAP38) with and without treatment with sumatriptan in patients with rosacea

Condition or disease Intervention/treatment Phase
Rosacea Drug: Imigran Other: Isotonic Saline Not Applicable

Detailed Description:

Pituitary adenylate cyclase-activating peptide-38 (PACAP38) plays a role in rosacea pathophysiology. Infusions of PACAP38 can trigger migraine-like attacks in migraine patients. PACAP38 also induces flushing which may imitate rosacea-like flushing. We are investigating whether the flushing after PACAP38 resembles rosacea-like flushing, and whether treatment with sumatriptan has an effect on the headache and flushing effects of PACAP38.

The purpose of this study is to investigate PACAP38-induced headache and flushing in patients with rosacea who have been treated with either sumatriptan or placebo using purpose-developed standardized interview. The investigators will use a double-blind, placebo-controlled crossover study design to investigate this.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: Investigation of PACAP38-induced Headache and Rosacea-like Symptoms in Patients With Rosacea
Actual Study Start Date : November 12, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Rosacea
Drug Information available for: Sumatriptan

Arm Intervention/treatment
Active Comparator: PACAP38 + Imigran

Pituitary adenylate cyclase-activating peptide-38 infusion (10 picomol/kg/min) for 20 mins

AND

Imigrane infusion (0.4 mg/min) for 10 mins

Drug: Imigran
All patients will undergo this intervention on one of two study days
Other Name: Sumatriptan

Placebo Comparator: PACAP38 + Isotonic Saline

Pituitary adenylate cyclase-activating peptide-38 infusion (10 picomol/kg/min) for 20 mins

AND

Isotonic saline for 10 mins (placebo)

Other: Isotonic Saline
All patients will undergo this intervention on one of two study days




Primary Outcome Measures :
  1. Incidence of headache and migraine [ Time Frame: From 0 to 24 hours after infusion ]
    Incidence of PACAP38-induced headache and migraine-like attacks in patients with rosacea measured by numerical rating scale for pain from 0 ("no pain") to 10 ("worst pain imaginable") and international classification for migraine.

  2. Effect of sumatriptan [ Time Frame: From 0 to 24 hours after infusion ]
    Severity of PACAP38-induced headache after pretreatment with sumatriptan in rosacea patients measured by numerical rating scale for pain from 0 ("no pain") to 10 ("worst pain imaginable")


Secondary Outcome Measures :
  1. Severity of flushing [ Time Frame: From 0 to 4 hours after infusion ]
    Severity of PACAP38-induced flushing with and without sumatriptan-treatment measured by laser doppler flowmetry

  2. Facial temperature [ Time Frame: From 0 to 4 hours after infusion ]
    PACAP38-induced temperature changes with and without sumatriptan-treatment measured by infrared thermography

  3. Superficial temporal artery diameter [ Time Frame: From 0 to 4 hours after infusion ]
    Superficial temporal artery diameter after PACAP38 with and without sumatriptan-treatment measured by ultrasound



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosed with rosacea
  • weight between 50 - 100 kilograms
  • women in fertile age must not be pregnant and must use adequate contraception

Exclusion Criteria:

  • migraine more than 5 days per month in average over the past year
  • any primary headache other than migraine, apart from tension-type headache which must be less than 5 days per month
  • headache < 48 hours before experimental day
  • migraine < 72 hours before each experimental day
  • daily / frequent use of any medication apart from contraceptive medication
  • use of any drug less than 5 times the half-life of the drug at the time of the experiment
  • women who are pregnant or breast-feeding at the time of the experiment
  • anamnestic or clinical signs of hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg) or hypotension (systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 50 mmHg)
  • anamnestic or clinical signs of mental illness, or abuse of alcohol / drugs
  • patients with glaucoma or prostate hyperplasia
  • anamnestic or clinical symptoms of any sort that the investigating doctor deemed unfit for participating in the study

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): NCT03878784


Contacts
Layout table for location contacts
Contact: Nita KF Wienholtz, MD +45 3863 4612 nwie0008@regionh.dk

Locations
Layout table for location information
Denmark
DanishHC Recruiting
Glostrup, Denmark, DK-2600
Contact: Nita KF Wienholtz, MD    +45 3863 4612    nwie0008@regionh.dk   
Sponsors and Collaborators
Danish Headache Center
Investigators
Layout table for investigator information
Principal Investigator: Messoud Ashina, MD,PhD,DMSc Professor

Layout table for additonal information
Responsible Party: Nita Katarina Frifelt Wienholtz, Principal Investigator, Medical Doctor, PhD Student, Danish Headache Center
ClinicalTrials.gov Identifier: NCT03878784     History of Changes
Other Study ID Numbers: RosMigExperiment
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Sumatriptan
Headache
Rosacea
Pain
Neurologic Manifestations
Signs and Symptoms
Skin Diseases
Pituitary Adenylate Cyclase-Activating Polypeptide
Growth Substances
Physiological Effects of Drugs
Vasodilator Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents