NCT00380263

Brief Summary

To investigate headache score and accompanying symptoms during and after infusion of PACAP38 i migraine patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2006

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

September 21, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

May 30, 2008

Status Verified

May 1, 2008

Enrollment Period

1 year

First QC Date

September 21, 2006

Last Update Submit

May 29, 2008

Conditions

Migraine Without Aura

Interventions

PACAP38DRUG

10 pmol/kg/min given one time

Eligibility Criteria

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

You may qualify if:

  • Healthy migraine patient without aura
  • Aged 18-50
  • Fertile women must use safe contraceptives (IUD, oral contraceptives, surgical sterilisation and long lasting gestagen.

You may not qualify if:

  • Tension type headache more than five times/month
  • Other primary headaches
  • Daily medication except contraceptives
  • Drug taken within 4 times the halflife for the specific drug except contraceptives
  • Pregnant or lactating women
  • Exposure to radiation within the last year
  • Headache within the last 48 hours before start of trial
  • Hypertension
  • Hypotension
  • Respiratory or cardiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dansih Headache Center

Glostrup Municipality, 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 Officials

  • Henrik Schytz, MD

    Danish Headache Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 21, 2006

First Posted

September 25, 2006

Study Start

November 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

May 30, 2008

Record last verified: 2008-05

Locations

DK(1)