NCT02364453

Brief Summary

The purpose of this study is to determine the effects of antihistamine (Clemastin) on migraines triggered by pituitary adenylate cyclase activating peptide-38 (PACAP38) as well as on biochemical markers for mast cell degranulation in migraine patients. Also, to investigate the occurrence of migraine in migraine patients after infusion of PACAP38 in lower dosages than previously investigated. As this has never been done before it is unknown how a lower dose of PACAP38 will affect 1) the incidence of migraine attacks, 2) the accompanying symptoms, 3) head pain characteristics, and 4) debut and duration of migraine attacks. Our three hypotheses are:

  1. 1.Pre-treatment with Clemastin reduces PACAP38 sensitivity and inhibits development of migraine in migraine patients.
  2. 2.Clemastin inhibits the increase in plasma concentration of TNF-alpha, histamine and tryptase after PACAP38-infusion.
  3. 3.PACAP38 in lower dosages (4, 6 and 8 pmol/kg/min) induces migraine in migraine patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

February 15, 2018

Status Verified

February 1, 2018

Enrollment Period

1.2 years

First QC Date

October 7, 2014

Last Update Submit

February 13, 2018

Conditions

Migraine Without Aura

Outcome Measures

Primary Outcomes (1)

  • Development of migraine in migraine patients

    Up to 12 months

Study Arms (2)

Placebo to PACAP38

EXPERIMENTAL

Pre-treatment with placebo. PACAP38 8pmol/kg/min

Drug: PACAP38

Clemastin 1 mg/ml to PACAP38 8pmol/kg/min

EXPERIMENTAL

Pre-treatment with Clemastin 1 mg/ml PACAP38 8 pmol/kg/min

Drug: PACAP38

Interventions

PACAP38DRUG

Giving doses of 4, 6 or 8 pg/kg/min on three separate trial days.

Also known as: Pituitary Adenylate Cyclase Activating Peptide 38
Clemastin 1 mg/ml to PACAP38 8pmol/kg/minPlacebo to PACAP38

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • migraine patients fulfilling IHS criteria for migraine without aura, ages 18-50, 50-100 kg, fertile women must be using safe prevention

You may not qualify if:

  • other types of primary headache than migraine
  • headache on trial day or later than 48 hours before trial day
  • migraine up to three days before trial day
  • any type of cardiovascular disease
  • clinical signs or patient history of any type of illness that the medical doctor in charge of trials deems relevant for participation

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 Officials

  • Messoud Ashina, Professor

    Danish Headache Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Doctor, PhD.-student

Study Record Dates

First Submitted

October 7, 2014

First Posted

February 18, 2015

Study Start

February 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

February 15, 2018

Record last verified: 2018-02

Locations

DK(1)