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Trial record 15 of 235 for:    CALCITONIN SALMON

CGRP-induced Migraine Attacks in Patients Who Have Tried Anti-CGRP Monoclonal Antibody Treatment

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ClinicalTrials.gov Identifier: NCT03481400
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Casper Emil Christensen, Danish Headache Center

Tracking Information
First Submitted Date  ICMJE March 13, 2018
First Posted Date  ICMJE March 29, 2018
Last Update Posted Date March 29, 2018
Actual Study Start Date  ICMJE July 2016
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2018)
  • Incidence of migraine [ Time Frame: From 0 to 12 hours after CGRP infusion ]
    Incidence of migraine after CGRP infusion
  • Area under the curve of headache intensity [ Time Frame: From 0 to 90 minutes after infusion and from 90 minutes to 12 hours after infusion ]
    Area under the curve of headache intensity from 0-90 min and 90 min-12 hours post infusion
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2018)
  • Heart rate [ Time Frame: From 0 to 90 minutes after infusion ]
    Heart rate (beats per minute)
  • Blood pressure [ Time Frame: From 0 to 90 minutes after infusion ]
    Blood pressure (millimeter of mercury)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CGRP-induced Migraine Attacks in Patients Who Have Tried Anti-CGRP Monoclonal Antibody Treatment
Official Title  ICMJE Provoked Migraine Attacks With Calcitonin Gene-related Peptide (CGRP) in Patients Who Have Tried Preventive Treatment With Anti-CGRP Monoclonal Antibodies.
Brief Summary The investigators aim to investigate the incidence of migraine attacks after calcitonin gene-related peptide (CGRP) infusion in patients who have tried anti-CGRP monoclonal antibody treatment for the prevention of migraine.
Detailed Description

Calcitonin gene-related peptide (CGRP) plays a role in migraine pathophysiology. Infusions of CGRP can trigger migraine-like attacks in migraine patients and antibodies against CGRP or the CGRP receptor significantly reduces the number of migraine days per month when administered regularly. Some patients however, do not experience migraine attack after CGRP infusion, and some do not experience migraine reduction with antibodies. The underlying mechanisms of these effects are largely unknown.

The purpose of this study is to examine CGRP-induced migraine in patients who have evaluated the efficacy of anti-CGRP monoclonal antibody treatment for migraine using a purpose-developed standardized interview. The investigators will use a double-blind, placebo-controlled crossover study design to examine migraine susceptibility to CGRP in these patients.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Placebo-controlled, crossover design.
Masking: Double (Participant, Investigator)
Masking Description:
Double-blind study.
Primary Purpose: Other
Condition  ICMJE Migraine
Intervention  ICMJE
  • Drug: Calcitonin Gene-Related Peptide
    Calcitonin gene-related peptide intravenous infusion (1.5 micrograms/min for 20 mins)
    Other Name: CGRP
  • Other: Placebo
    Isotonic saline
Study Arms  ICMJE
  • Experimental: Calcitonin gene-related peptide
    Calcitonin gene-related peptide infusion (1.5 micrograms/min for 20 mins)
    Intervention: Drug: Calcitonin Gene-Related Peptide
  • Experimental: Placebo
    Infusion with placebo (isotonic saline)
    Intervention: Other: Placebo
Publications * Christensen CE, Younis S, Deen M, Khan S, Ghanizada H, Ashina M. Migraine induction with calcitonin gene-related peptide in patients from erenumab trials. J Headache Pain. 2018 Nov 8;19(1):105. doi: 10.1186/s10194-018-0927-2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 27, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of migraine according to the international classification of headache disorders version 3-beta
  • Subject has tried anti-CGRP antibodies for migraine
  • Women of childbearing potential are on safe contraception

Exclusion Criteria:

  • Women of childbearing potential who do not use contraception. Includes non-hysterectomized women who have not been menopausal for at least two years. Safe contraception includes condoms, intrauterine devices, p-pills, surgical sterilization or gestagen injections.
  • Daily drug intake apart from contraceptives and preventive medication for migraine.
  • Ingestion of any drug 4 half-lifes before study start apart from contraceptives.
  • Pregnant or breast-feeding women
  • Migraine on the study day or less than 48 hours before CGRP infusion.
  • A history of cardiovascular and/or cerebrovascular disease
  • Systolic blood pressure >150 mmHg and/or diastolic blood pressure > 100 mmHg on study day.
  • Systolic blood pressure <90 mmHg and/or diastolic blood pressure < 50 mmHg on study day.
  • A history of mental illness
  • A history of any illness or condition that is deemed relevant for participation by the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Casper E Christensen, MD 38632027 casper.emil.christensen.03@regionh.dk
Contact: Samaira Younis, MD 38632176 samaira.younis.01@regionh.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03481400
Other Study ID Numbers  ICMJE H-16014580
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Casper Emil Christensen, Danish Headache Center
Study Sponsor  ICMJE Danish Headache Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Messoud Ashina, prof. Danish Headache Center
PRS Account Danish Headache Center
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP