NCT00399633

Brief Summary

The study aim at examining whether Sumatriptan changes the plasma values of the neuropeptides vasoactive intestinal polypeptide (VIP), calcitonin gene-related peptide (CGRP) and pituitary adenylate cyclase activating peptide (PACAP) and the prostanoids 6-keto-PGF1α, and PGE2, PGD2 og PGF2α.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jan 2007

Shorter than P25 for not_applicable healthy

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

First Submitted

Initial submission to the registry

November 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

May 14, 2008

Status Verified

May 1, 2008

Enrollment Period

3 months

First QC Date

November 14, 2006

Last Update Submit

May 13, 2008

Conditions

HealthyMigraine

Keywords

VIPPACAPCGRPProstanoids

Outcome Measures

Primary Outcomes (5)

  • Blood concentration of vasoactive intestinal polypeptide (VIP),

  • calcitonin gene-related protein (CGRP), pituitary adenylate cyclase

  • activating peptide (PACAP,) and the prostanoids

  • 6-keto-PGF1α, PGE2, PGD2 and PGF2α, sampled from different

  • venous catheters.

Interventions

sumatriptanDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteers
  • years,
  • kg.
  • Fertile women must use birth control.

You may not qualify if:

  • All primary types of headache
  • Daily intake of medicine except birth control
  • Pregnancy
  • Hypertension
  • Hypotension
  • other chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Headache Center

Glostrup, Copenhagen, Copenhagen, 2600, Denmark

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Sumatriptan

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsTryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jakob Møller Hansen, MD

    Danish Headache Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 14, 2006

First Posted

November 15, 2006

Study Start

January 1, 2007

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

May 14, 2008

Record last verified: 2008-05

Locations

DK(1)