Hypersensitivity to PACAP-38 in Post-Traumatic Headache

Post-Traumatic Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05378061
• Other study ID #: H-21048416
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2022
• Source: Danish Headache Center
• Contact: Hakan Ashina, MD
• Phone: 00 45 28 10 24 95
• Email: haakan.ashina[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Hypersensitivity
• Post-Traumatic Headache

Intervention

Drug:
• Pituitary adenylate cyclase activating polypeptide-38
Study participants will be allocated to receive continuous intravenous infusion of 10 pmol/kg/min PACAP-38.
• Placebo
Study participants will be allocated to receive continuous intravenous infusion of 20 mL placebo (isotonic saline).

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Migraine-Like Headache	Difference in incidence of headache with migraine-like features (0 to 12 hours) between PACAP-38 and placebo.	12 Hours
Secondary	Headache Intensity Scores	Difference in area under the curve (AUC) for headache intensity scores (0 to 12 hours) between PACAP-38 and placebo.	12 Hours