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Trial record 13 of 245 for:    Recruiting, Not yet recruiting, Available Studies | Headache

PACAP-38 Infusion in Patients With Cluster Headache

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ClinicalTrials.gov Identifier: NCT03814226
Recruitment Status : Recruiting
First Posted : January 23, 2019
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Agneta Snoer, Danish Headache Center

Brief Summary:
A randomized, double-blinded, two-way crossover study investigating the headache inducing capabilities of PACAP-38 in patients with cluster headache. Forty-five patients (15 episodic patients in cluster, 15, episodic patients in remission and 15 chronic cluster headache patients) are expected to participate. Each patients will on two separate study days in a randomized way receive an infusion of PACAP-38 and VIP over 20 minutes followed by an observation period of 70 minutes. Blood samples for investigation of VIP, PACAP38; CGRP, NSE, Histamine and Tryptase will be drawn at fixed time-points during experiment.

Condition or disease Intervention/treatment Phase
Cluster Headache Other: Evaluation of headache inducing capabilities of PACAP38 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of PACAP-38 Infusion in Inducing Headache in Patients With Cluster Headache
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : May 5, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Experimental: PACAP-38 infusion
According to main hypothesis PACAP-38 is expected to induce headache. PACAP-38 causes marked vasodilation visible to investigator. PACAP38 (10 pmol/kg/min) is infused over 20 minutes, patients are observed before (15 minutes), during and after (70 minutes) infusion. Blood samples are drawn at fixed time-points.
Other: Evaluation of headache inducing capabilities of PACAP38
We wish to investigate the headache inducing capabilities of PACAP-38, a vasoactive peptide, over a 20 minute infusion. As PACAP-38 casues visible vasodilation, another vasoactive peptide, called VIP will be used as an active comparator.

Active Comparator: VIP infusion
According to main hypothesis VIP is not expected to induce headache. VIP also causes marked vasodilation visible to investigator, which is why VIP is chosen as an active comparator. VIP (10 pmol/kg/min) is infused over 20 minutes. VIP is infused over 20 minutes, patients are observed before (15 minutes), during and after (70 minutes) infusion. Blood samples are drawn at fixed time-points.
Other: Evaluation of headache inducing capabilities of PACAP38
We wish to investigate the headache inducing capabilities of PACAP-38, a vasoactive peptide, over a 20 minute infusion. As PACAP-38 casues visible vasodilation, another vasoactive peptide, called VIP will be used as an active comparator.




Primary Outcome Measures :
  1. Headache [ Time Frame: 90 minutes ]
    Difference in incidence of headache within 90 minutes of infusion between PACAP-38 infusion and VIP infusion

  2. Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE [ Time Frame: 90 minutes ]
    Changes in plasma/serum concentrations of the following markers after infusion of PACAP-38 and VIP: PACAP-38, VIP, CGRP, Histamine, Tryptase, NSE

  3. Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE after infusion [ Time Frame: 90 minutes ]
    Difference in plasma/serum concentrations of the following markers after infusion of PACAP-38 and VIP: PACAP-38, VIP, CGRP, Histamine, Tryptase, NSE between patients with induced cluster headache and patients without headache

  4. Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE at baseline [ Time Frame: 90 minutes ]
    Difference in plasma/serum concentrations of the following markers at baseline: PACAP-38, VIP, CGRP, Histamine, Tryptase, NSE between patients with episodic cluster headache in remission, episodic cluster headache in cluster, and chronic cluster headache

  5. Headache intensity [ Time Frame: 90 minutes ]
    Difference in AUD for headache intensity scores (0-90 minutes)

  6. Time to headache peak [ Time Frame: 90 minutes ]
    Difference in time to peak headache between PACAP-38 day and VIP day


Secondary Outcome Measures :
  1. Change in mean arterial blood pressure [ Time Frame: 90 minutes ]
    Difference in area under the curve (AUC) for mean arterial pressure (based on systolic and diastolic measurements) and heart rate during experiment

  2. Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE [ Time Frame: Baseline ]
    Difference in serum/plasma levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE at baseline in patients who develop a cluster headache attack compared to those who do not



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Episodic or chronic cluster headache according to international classification of headache disorders
  • Age 18-65 years
  • Weight 50-100 kg
  • If women of childbearing potential, then must use safe contraceptives

Exclusion Criteria:

  • Episodic tension-type headache > 15 days per month
  • Other primary headache disorders, except tension-type headache < 5 days per month
  • Episodic cluster headache patients outside cluster must be completely headache free a minimum of 8 hours prior to experiment
  • Episodic cluster headache patients in cluster and chronic cluster headache patients must be completely headache free a minimum of 4 hours prior to experiment
  • Current or recent use (30 days) of injected or oral corticosteroids
  • Pregnant or lactating women
  • A history or clinical signs of hypertension (BP > 150mmHg systolic / 100mmHg diastolic)
  • A history or clinical signs of hypotension (BP <90 mmHg systolic / 50mmHg diastolic)
  • A history of cardiovascular or cerebrovascular disease
  • A history of psychiatric disease or substance abuse
  • A medical history or clinical signs of disease that according to investigator would preclude participation 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): NCT03814226


Contacts
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Contact: Agneta Snoer, MD + 45 26274040 agneta.henriette.snoer.02@regionh.dk
Contact: Luise Vollsen, MD +45 25732284 luisevollsen@gmail.com

Locations
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Denmark
Danish Headache Center Recruiting
Glostrup, Denmark, 2620
Contact: Agneta Snoer, MD    + 45 26274040    agneta.henriette.snoer.02@regionh.dk   
Sub-Investigator: Anne Luise Vollesen, MD         
Principal Investigator: Messoud Ashina, DMSc         
Sponsors and Collaborators
Danish Headache Center
Investigators
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Principal Investigator: Messoud Ashina, Professor Danish Headache Center

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Responsible Party: Agneta Snoer, MD, PhD Student, Investigator, Danish Headache Center
ClinicalTrials.gov Identifier: NCT03814226     History of Changes
Other Study ID Numbers: H-17011569
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cluster Headache
Headache
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Pain
Neurologic Manifestations
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pituitary Adenylate Cyclase-Activating Polypeptide
Growth Substances
Physiological Effects of Drugs
Vasodilator Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action