Hypersensitivity to PACAP-38 in Post-Traumatic Headache

Sponsor
Danish Headache Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05378061
Collaborator
(none)
21
1
2
18.5
1.1

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Pituitary adenylate cyclase activating polypeptide-38
  • Drug: Placebo
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Hypersensitivity to PACAP-38 in Post-Traumatic Headache: A Randomized Clinical Trial
Actual Study Start Date :
Jun 16, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: PACAP-38

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

Drug: Pituitary adenylate cyclase activating polypeptide-38
Study participants will be allocated to receive continuous intravenous infusion of 10 pmol/kg/min PACAP-38.
Other Names:
  • PACAP-38
  • Placebo Comparator: Placebo (isotonic saline)

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

    Drug: Placebo
    Study participants will be allocated to receive continuous intravenous infusion of 20 mL placebo (isotonic saline).
    Other Names:
  • Isotonic Saline
  • Outcome Measures

    Primary Outcome Measures

    1. Incidence of Migraine-Like Headache [12 Hours]

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

    Secondary Outcome Measures

    1. Headache Intensity Scores [12 Hours]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Danish Headache Center Copenhagen Denmark 2600

    Sponsors and Collaborators

    • Danish Headache Center

    Investigators

    • Principal Investigator: Hakan Ashina, MD, Danish Headache Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Håkan Ashina, MD, Danish Headache Center
    ClinicalTrials.gov Identifier:
    NCT05378061
    Other Study ID Numbers:
    • H-21048416
    First Posted:
    May 17, 2022
    Last Update Posted:
    Jun 22, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Håkan Ashina, MD, Danish Headache Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 22, 2022