Pharmacologically Triggered Migraine Without Aura and Neu... | NCT03143465

Studies
Pharmacologically Triggered Migraine Without Aura and Neuroimaging

NCT03143465

Sponsor

Danish Headache Center

Status

Unknown status

Last Update Posted

Feb 15, 2019Actual

Enrollment

36Estimated

Phase

Not Applicable

Conditions

Migraine With Aura

Interventions

Calcitonin Gene-Related Peptide
Sildenafil
Placebo

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 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016Actual

Primary Completion Date

Dec 2018Actual

Completion Date

May 2019Estimated

First Submitted Date

May 4, 2017

First Submission Date that Met QC Criteria

May 4, 2017

First Posted Date

May 8, 2017Actual

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 11, 2019

Last Update Posted Date

Feb 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Migraine is a highly disabling disorder affecting 14% of the general population Worldwide and ranked as the 6th most debilitating disease worldwide by the WHO. One of the most fundamental questions of migraine, which remains to be elucidated, is the mechanism behind the generation of migraine attacks.

The investigators will use calcitonin gene-related peptide (CGRP) and sildenafil as pharmacological triggers of migraine, combined with advanced neuroimaging techniques, to investigate the attack initiating pathophysiology.

Both substances have previously been administered to healthy participants and migraine without aura patients, inducing headache and migraine-like-attacks.

The investigators hope to contribute with novelty to the current understanding of the migraine pathophysiology and development of more efficient treatment of migraine.

Detailed Description

Not provided

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

36Estimated

Label	Type	Intervention Names
CGRP	Experimental	Drug: Calcitonin Gene-Related Peptide
Sildenafil	Experimental	Drug: Sildenafil
Placebo	Placebo Comparator	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Calcitonin Gene-Related Peptide	Drug		CGRP
Sildenafil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CGRP and sildenafil induced headache and MRI changes	CGRP and sildenafil induced headache and MRI changes	0- 12h

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 18 and 50 years
Weight: 50-100 kg
Diagnosis of migraine without aura (patient group only)
Attacks of migraine without aura at least once every second month (patient group only)

Exclusion Criteria:

Inconsistent laterality of headache
History or family history of migraine (healthy subject group only)
Tension-type headache more than one day per month on average (healthy subject group only)
Tension-type headache to such a degree that the episodic migraine diagnosis is no longer fulfilled
Any other primary headache disorder
Daily intake of medication (apart from oral contraceptives)
Intake of any medication less than 4 half-lives before study start
Daily smoking
Pregnant or breastfeeding women
Headache 48 h prior to study day
Hypertension on the study day (systolic BP>150 mmHg or diastolic BP> 100 mmHg)
Hypotension on the study day (systolic BP<90 mmHg or diastolic BP<50 mmHg)
History of any cardiovascular disease including cerebrovascular disease
Any disorder, that is deemed ineligible for participation by the study physicians
Contraindications of MRI
No use of safe contraception (women of fertile age only)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31684759	Derived	Younis S, Christensen CE, Toft NM, Soborg T, Amin FM, Hougaard A, Ashina M. Investigation of distinct molecular pathways in migraine induction using calcitonin gene-related peptide and sildenafil. Cephalalgia. 2019 Dec;39(14):1776-1788. doi: 10.1177/0333102419882474. Epub 2019 Nov 4.
31060491	Derived	Christensen CE, Younis S, Lindberg U, Boer VO, de Koning P, Petersen ET, Paulson OB, Larsson HBW, Amin FM, Ashina M. Ultra-high field MR angiography in human migraine models: a 3.0 T/7.0 T comparison study. J Headache Pain. 2019 May 6;20(1):48. doi: 10.1186/s10194-019-0996-x.

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

ID	Term
D015740	Calcitonin Gene-Related Peptide
D000068677	Sildenafil Citrate

ID	Term
D009479	Neuropeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D009419	Nerve Tissue Proteins