PACAP27 Headache Properties in Migraine Without Aura Pati... | NCT03471039

Studies
PACAP27 Headache Properties in Migraine Without Aura Patients

NCT03471039

Sponsor

Danish Headache Center

Status

Completed

Last Update Posted

Jan 24, 2019Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Migraine Without Aura

Interventions

PACAP27
Saline

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

Jan 2019

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

Aug 30, 2017Actual

Primary Completion Date

Aug 30, 2018Actual

Completion Date

Sep 30, 2018Actual

First Submitted Date

Mar 1, 2018

First Submission Date that Met QC Criteria

Mar 13, 2018

First Posted Date

Mar 20, 2018Actual

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

Jan 23, 2019

Last Update Posted Date

Jan 24, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

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

20Actual

Label	Type	Description	Intervention Names
Active	Active Comparator	PACAP-27	Drug: PACAP27
Placebo	Placebo Comparator	Saline	Drug: Saline

Name	Type	Description	Arm Group Labels	Other Names
PACAP27	Drug	Infusion of PACAP27 over 20 minutes.	Active
Saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Headache Scores	Comparison between PACAP27 and Placebo	0-12 hours

Secondary Outcomes

Measure	Description	Time Frame
Facial blood flow (flushing)	PACAP27 induces facial flushing compare to placebo measured by laser speckle contrast imaging	0-120 mins

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Migraine patients meeting International Headache Society (IHS) criteria for migraine without aura of both sexes, 18-60 year, 50-100 kg.
- Fertile women should use safe contraception. Fertile women do not include hysterectomized women or women who are postmenopausal for at least 2 years. Safe contraception includes either Intra Uterine Device (IUD), birth control pills, surgical sterilization of the woman or depot progestogen.

Exclusion Criteria:

Tension Type headache for more than 5 days the month on average in the last year.
- All other primary headaches .
- Headache later than 48 hours before trial start.
- Daily intake of any medicine other than oral contraception.
- Ingestion of any form of medicinal product later than 4 times the plasma half-life substance (on trial day), except for oral contraception.
- Pregnant or breastfeeding women.
- Headache on the test day or later than 48 hours prior to administration of trial medicine / placebo
- Migraine within 5 days before the trial date.
- Ancestral information or clinical signs of (on the day of inclusion):
Hypertension (systolic blood pressure> 150 mmHg and / or diastolic blood pressure> 100 mmHg)
Hypotension (systolic blood pressure <90 mm Hg and / or diastolic blood pressure <50 mmHg)
- Cardiovascular disease of all kinds, including cerebrovascular disease.
- Anamnestic or clinical signs of mental illness or abuse.
- Patients with glaucoma or prostatic hyperplasia
- Anamnestic or clinical signs of diseases of any kind such as the investigating physician is considered relevant for participation in the trial.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

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

ID	Term
D051219	Pituitary Adenylate Cyclase-Activating Polypeptide
D012965	Sodium Chloride

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