NCT01924052

Brief Summary

The investigators hypothesized that migraine without patients with many genetic loci associated with migraine (high genetic load) would be more sensitive and get provoked more migraine attacks by calcitonin gene-related peptide (CGRP) compared to patients with few genetic loci associated with migraine (low genetic load).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 16, 2013

Completed
Last Updated

August 2, 2022

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

August 10, 2013

Last Update Submit

July 31, 2022

Conditions

Migraine Without Aura

Outcome Measures

Primary Outcomes (1)

  • CGRP induced migraine attacks in patients with high and low genetic load

    The difference in incidence of migraine-like attacks between patients with high genetic load and patients with low genetic load using verbal rating scale (VRS).

    Change from baseline in headache intensity at 12 hours after the start of infusion of CGRP

Secondary Outcomes (1)

  • CGRP induced migraine attacks in patients with high and low genetic load

    Change from baseline in headache intensity at 12 hours after the start of infusion of CGRP

Study Arms (2)

Migraine patients with high genetic load

ACTIVE COMPARATOR

CGRP intravenous infusion 1.5 microgram/min for 20 min

Drug: CGRP

Migraine patients with low genetic load

ACTIVE COMPARATOR

CGRP intravenous infusion 1.5 microgram/min for 20 min

Drug: CGRP

Interventions

CGRPDRUG

Calcitonin-gene-related-peptide (CGRP)

Also known as: calcitonin-gene-related peptide
Migraine patients with high genetic loadMigraine patients with low genetic load

Eligibility Criteria

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

You may qualify if:

  • \- Migraine without aura patients genotyped for the 12 newly idetified gene variants associated with migraine.

You may not qualify if:

  • Other primary headache
  • A history of cerebrovascular disease and other CNS- disease
  • A history suggesting ischaemic heart disease
  • Serious somatic and mental disease
  • Hypo- or hypertension
  • Abuse of alcohol or medicine (opioid analgesics).
  • Pregnant or breastfeeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Migraine without Aura

Interventions

Calcitonin

Condition Hierarchy (Ancestors)

Migraine DisordersHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Peptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsThyroid HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Song Guo, MD

    Danish Headache Center & Department of Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 10, 2013

First Posted

August 16, 2013

Study Start

June 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

August 2, 2022

Record last verified: 2022-07