We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients

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: NCT02466334
Recruitment Status : Recruiting
First Posted : June 9, 2015
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

It has previously been shown that nitroglycerine induces cluster headache attacks in episodic cluster headache patients (ECH patients) in bouts but not in remission phase. Furthermore, plasma concentrations of calcitonin gene-related peptide (CGRP) have been shown to be significantly higher during, but not before and after, an attack.

The attack appears around 20-40 min after nitroglycerine infusion with vasodilatation. During this latency period preceding the attack, no increase in CGRP plasma concentrations is seen. CGRP induces migraine attacks in 65% of migraine patients, and CGRP antagonists as well as monoclonal antibodies against CGRP are effective in migraine treatment.

Based on the above the investigators hypothesize the following:

  1. Provoking ECH patients in bout with CGRP triggers cluster headache attacks
  2. Provoking ECH patients in remission with CGRP does not trigger cluster headache attacks
  3. Provoking chronic cluster headache patients with CGRP triggers cluster headache attacks more often than in ECH patients.

Condition or disease Intervention/treatment
Cluster Headache Drug: Calcitonin-Gene Related Peptide Drug: Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients
Study Start Date : June 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Active
1.5µg/min IV calcitonin-gene related peptide for 20 minutes
Drug: Calcitonin-Gene Related Peptide
1,5 µg/min of IV CGRP over 20 mins
Other Name: CGRP
Placebo Comparator: Placebo
IV placebo for 20 minutes
Drug: Placebo
40 ml of normal saline over 20 mins
Other Name: Normal saline


Outcome Measures

Primary Outcome Measures :
  1. Differences in occurence of cluster headache attacks [ Time Frame: One hour after administration of study drug ]
    Using a 24 hour headache questionnaire


Secondary Outcome Measures :
  1. AUC headache [ Time Frame: 24 hours ]

Other Outcome Measures:
  1. Time to maximum headache score after CGRP vs. placebo [ Time Frame: 24 hours ]

Eligibility Criteria

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.


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

Inclusion Criteria:

  • Fulfillment of IHS criteria for cluster headache either chronic or episodic
  • Patients in bouts 1-32 attacks per week
  • Patients in remission minimum of 1 month remission time
  • fertile women must use safe contraception

Exclusion Criteria:

  • All other primary types of headache
  • daily intake of medication other than Verapamil and oral contraceptives
  • headache 8 hours or less before study day begins
  • intake of any drug other than mentioned above less than four times half life of the drug on study day
  • pregnant or lactating women
  • any history or clinical sigs of hyper/hypotension, heart disease, mental disorder, substance abuse, or other illness deemed relevant by the medical doctor assessing the patient
Contacts and Locations

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): NCT02466334


Contacts
Contact: Luise H Vollesen, MD luisevollesen@gmail.com
Contact: Agneta H Snoer, MD

Locations
Denmark
Danish Headache Center Recruiting
Copenhagen, Glostrup, Denmark, 2600
Contact: Song Guo, MD    +45 38633470    song.guo.01@regionh.dk   
Sponsors and Collaborators
Danish Headache Center
Investigators
Principal Investigator: Messoud Ashina, MD, PhD,DMSc Danish Headache Center
More Information

Responsible Party: Song Guo, Medical doctor, Ph.d. student, Danish Headache Center
ClinicalTrials.gov Identifier: NCT02466334     History of Changes
Other Study ID Numbers: H-15006836
First Posted: June 9, 2015    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Headache
Cluster Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Salmon calcitonin
Calcitonin
Calcitonin Gene-Related Peptide
Bone Density Conservation Agents
Physiological Effects of Drugs
Vasodilator Agents