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Hypersensitivity to PACAP-38 in Post-Traumatic Headache

Primary Purpose

Post-Traumatic Headache

Status

Recruiting

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Pituitary adenylate cyclase activating polypeptide-38

Placebo

About this trial

This is an interventional basic science trial for Post-Traumatic Headache focused on measuring Headache, Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18 to 65 years of age upon entry into screening
History of persistent headache attributed to mild traumatic injury to the head for ≥ 12 months and in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3)
≥ 4 monthly headache days on average across the 3 months prior to screening
Provision of informed consent prior to initiation of any study-specific activities/procedures.

Exclusion Criteria:

> 1 mild traumatic injury to the head
History of any primary or secondary headache disorder prior to mild traumatic injury to the head (except for infrequent episodic tension-type headache)
History of moderate or severe injury to the head
History of whiplash injury
History of craniotomy
History or evidence of any other clinically significant disorder, condition or disease (except for those outlined above) than, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion
The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
Female subjects of childbearing potential with a positive pregnancy test during any study visit
Cardiovascular disease of any kind, including cerebrovascular diseases
Hypertension (systolic blood pressure of ≥150 mmHg and/or diastolic blood pressure of ≥100 mmHg) prior to the start of infusion on the experimental day
Hypotension (systolic blood pressure of ≤90 mmHg and/or diastolic blood pressure of ≤50 mmHg)
Initiation, discontinuation, or change of dosing of prophylactic medications within 2 months prior to study inclusion
Intake of acute medications (e.g. analgesics, triptans) within 48 hours of infusion start
Baseline headache intensity of >3 on an 11-point numeric rating scale (0 being no headache, 10 being the worst imaginable headache)
Baseline headache with migraine-like features or self-reported baseline headache that mimics the subjects' usual headache with migraine-like features

Sites / Locations

Danish Headache CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PACAP-38

Placebo (isotonic saline)

Arm Description

A time- and volume-controlled infusion pump is used to administer PACAP-38 by intravenous infusion over 20 minutes.

A time- and volume-controlled infusion pump is used to administer placebo (isotonic saline) by intravenous infusion over 20 minutes.

Outcomes

Primary Outcome Measures

Incidence of Migraine-Like Headache

Difference in incidence of headache with migraine-like features (0 to 12 hours) between PACAP-38 and placebo.

Secondary Outcome Measures

Headache Intensity Scores

Difference in area under the curve (AUC) for headache intensity scores (0 to 12 hours) between PACAP-38 and placebo.

Full Information

NCT ID

NCT05378061

First Posted

May 12, 2022

Last Updated

June 18, 2022

Sponsor

Danish Headache Center

1. Study Identification

Unique Protocol Identification Number

NCT05378061

Brief Title

Hypersensitivity to PACAP-38 in Post-Traumatic Headache

Official Title

Hypersensitivity to PACAP-38 in Post-Traumatic Headache: A Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 16, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Danish Headache Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The aim is to investigate whether signaling molecule PACAP-38 induces headache with migraine-like features in people with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (mTBI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-Traumatic Headache

Keywords

Headache, Pain

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PACAP-38

Arm Type

Experimental

Arm Description

A time- and volume-controlled infusion pump is used to administer PACAP-38 by intravenous infusion over 20 minutes.

Arm Title

Placebo (isotonic saline)

Arm Type

Placebo Comparator

Arm Description

A time- and volume-controlled infusion pump is used to administer placebo (isotonic saline) by intravenous infusion over 20 minutes.

Intervention Type

Drug

Intervention Name(s)

Pituitary adenylate cyclase activating polypeptide-38

Other Intervention Name(s)

PACAP-38

Intervention Description

Study participants will be allocated to receive continuous intravenous infusion of 10 pmol/kg/min PACAP-38.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Isotonic Saline

Intervention Description

Study participants will be allocated to receive continuous intravenous infusion of 20 mL placebo (isotonic saline).

Primary Outcome Measure Information:

Title

Incidence of Migraine-Like Headache

Description

Difference in incidence of headache with migraine-like features (0 to 12 hours) between PACAP-38 and placebo.

Time Frame

12 Hours

Secondary Outcome Measure Information:

Title

Headache Intensity Scores

Description

Difference in area under the curve (AUC) for headache intensity scores (0 to 12 hours) between PACAP-38 and placebo.

Time Frame

12 Hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18 to 65 years of age upon entry into screening History of persistent headache attributed to mild traumatic injury to the head for ≥ 12 months and in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3) ≥ 4 monthly headache days on average across the 3 months prior to screening Provision of informed consent prior to initiation of any study-specific activities/procedures. Exclusion Criteria: > 1 mild traumatic injury to the head History of any primary or secondary headache disorder prior to mild traumatic injury to the head (except for infrequent episodic tension-type headache) History of moderate or severe injury to the head History of whiplash injury History of craniotomy History or evidence of any other clinically significant disorder, condition or disease (except for those outlined above) than, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior Female subjects of childbearing potential with a positive pregnancy test during any study visit Cardiovascular disease of any kind, including cerebrovascular diseases Hypertension (systolic blood pressure of ≥150 mmHg and/or diastolic blood pressure of ≥100 mmHg) prior to the start of infusion on the experimental day Hypotension (systolic blood pressure of ≤90 mmHg and/or diastolic blood pressure of ≤50 mmHg) Initiation, discontinuation, or change of dosing of prophylactic medications within 2 months prior to study inclusion Intake of acute medications (e.g. analgesics, triptans) within 48 hours of infusion start Baseline headache intensity of >3 on an 11-point numeric rating scale (0 being no headache, 10 being the worst imaginable headache) Baseline headache with migraine-like features or self-reported baseline headache that mimics the subjects' usual headache with migraine-like features

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hakan Ashina, MD

Phone

00 45 28 10 24 95

haakan.ashina@regionh.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hakan Ashina, MD

Organizational Affiliation

Danish Headache Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Danish Headache Center

City

Copenhagen

ZIP/Postal Code

2600

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Håkan Ashina, MD

Phone

+45 28 10 24 95

haakan.ashina@regionh.dk

12. IPD Sharing Statement

Learn more about this trial

Hypersensitivity to PACAP-38 in Post-Traumatic Headache

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