The Effect of Histamine H1 Receptor Antagonist, Clemastin... | NCT02364453

Studies
The Effect of Histamine H1 Receptor Antagonist, Clemastin, on PACAP38 Induced Headache in Migraine Patients

NCT02364453

Sponsor

Song Guo

Status

Completed

Last Update Posted

Feb 15, 2018Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Migraine Without Aura

Interventions

PACAP38

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Oct 7, 2014

First Submission Date that Met QC Criteria

Feb 10, 2015

First Posted Date

Feb 18, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2018

Last Update Posted Date

Feb 15, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Song Guo, Medical Doctor, PhD.-student, Danish Headache CenterSponsor-Investigator

Lead Sponsor

Song GuoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
PACAP38	Drug	Giving doses of 4, 6 or 8 pg/kg/min on three separate trial days.	Clemastin 1 mg/ml to PACAP38 8pmol/kg/min Placebo to PACAP38

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Development of migraine in migraine patients		Up to 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Messoud Ashina, Professor	Danish Headache Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Danish Headache Center & Department of Neurology		Copenhagen	Glostrup	2600	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D020326	Migraine without Aura

Ancestor Terms

ID	Term
D008881	Migraine Disorders
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D051219	Pituitary Adenylate Cyclase-Activating Polypeptide

Ancestor Terms

ID	Term
D009414	Nerve Growth Factors
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided