DelfaGLP-1 Atlas

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Not yet recruitingPhase NA

Hypersensitivity to Amylin in Post-Traumatic Headache

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

Asset

Pramlintide

Amylin analog

Listed sites

1

Recruiting sites

—

Enrollment

21

estimated

Study population

Brain Injuries, Headache Disorders

Key I/E criterion

—

Primary endpoint

•Migraine-like headache

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07340775
Org study IDH-21067689

Timeline

Milestones

Study first posted2026-01-14actual
Last update posted2026-01-14actual
Study start2026-02estimated (month precision)
Primary completion2028-12estimated (month precision)
Study completion2028-12estimated (month precision)

Assets

Investigational agents

Pramlintide

Study populations

Who this study enrolls

Brain InjuriesHeadache Disorders

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

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 migraine-like headache or self-reported baseline headache that mimics the subjects' usual migraine-like headache

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
1
Other clinical outcomes
1

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Incidence of migraine-like headache

Time frame:12 hours

event count, event

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Headache Intensity Scores

Time frame:12 hours

descriptive, improvement

Publications (7)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.