NCT03481400

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

3.2 years

First QC Date

March 13, 2018

Last Update Submit

March 27, 2018

Conditions

Migraine

Keywords

Calcitonin gene-related peptide

Outcome Measures

Primary Outcomes (2)

  • Incidence of migraine

    Incidence of migraine after CGRP infusion

    From 0 to 12 hours after CGRP infusion

  • Area under the curve of headache intensity

    Area under the curve of headache intensity from 0-90 min and 90 min-12 hours post infusion

    From 0 to 90 minutes after infusion and from 90 minutes to 12 hours after infusion

Secondary Outcomes (2)

  • Heart rate

    From 0 to 90 minutes after infusion

  • Blood pressure

    From 0 to 90 minutes after infusion

Study Arms (2)

Calcitonin gene-related peptide

EXPERIMENTAL

Calcitonin gene-related peptide infusion (1.5 micrograms/min for 20 mins)

Drug: Calcitonin Gene-Related Peptide

Placebo

EXPERIMENTAL

Infusion with placebo (isotonic saline)

Other: Placebo

Interventions

Calcitonin Gene-Related PeptideDRUG

Calcitonin gene-related peptide intravenous infusion (1.5 micrograms/min for 20 mins)

Also known as: CGRP
Calcitonin gene-related peptide
PlaceboOTHER

Isotonic saline

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Headache Center, Rigshospitalet Glostrup

Copenhagen, Glostrup, 2600, Denmark

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30409109DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Calcitonin Gene-Related Peptide

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

NeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Messoud Ashina, prof.

    Danish Headache Center

    STUDY DIRECTOR

Central Study Contacts

Casper E Christensen, MD

CONTACT

38632027casper.emil.christensen.03@regionh.dk

Samaira Younis, MD

CONTACT

38632176samaira.younis.01@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double-blind study.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Placebo-controlled, crossover design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD student

Study Record Dates

First Submitted

March 13, 2018

First Posted

March 29, 2018

Study Start

July 1, 2016

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

March 29, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)