NCT02158221

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 PACAP compared to patients with few genetic loci associated with migraine (low genetic load).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 10, 2015

Status Verified

February 1, 2015

Enrollment Period

5 months

First QC Date

June 5, 2014

Last Update Submit

February 9, 2015

Conditions

Migraine Without Aura

Outcome Measures

Primary Outcomes (1)

  • Incidence of migraine attacks induced by PACAP in patients with high and low genetic load.

    The difference in incidence of migraine-like attacks after PACAP between patients with and without 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 PACAP

Secondary Outcomes (1)

  • Incidence of headache induced by PACAP in patients with high and low genetic load.

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

Study Arms (2)

Migraine patients with high genetic load

ACTIVE COMPARATOR

PACAP intravenous infusion 1.5 microgram/min for 20 min

Drug: PACAP

Migraine patients with low genetic load

ACTIVE COMPARATOR

PACAP intravenous infusion 1.5 microgram/min for 20 min

Drug: PACAP

Interventions

PACAPDRUG

Pituitary adenylate cyclase-activating polypeptide (PACAP)

Also known as: Pituitary adenylate cyclase-activating polypeptide
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

Study Sites (1)

Danish Headache Center & Department of Neurology

Copenhagen, Glostrup, 2600, Denmark

Location

MeSH Terms

Conditions

Migraine without Aura

Interventions

Pituitary Adenylate Cyclase-Activating Polypeptide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nerve Growth FactorsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsNeuropeptidesProteinsNerve Tissue ProteinsBiological Factors

Study Design

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

Study Record Dates

First Submitted

June 5, 2014

First Posted

June 6, 2014

Study Start

June 1, 2014

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

February 10, 2015

Record last verified: 2015-02

Locations

DK(1)