DelfaGLP-1 Atlas

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CompletedPhase NA

Amylin and CGRP Head to Head Provocation in Migraine Without Aura Patients

Amylin and CGRP Migraine Provocation in Migraine Without Aura Patients

Assets

GLP-1 / incretin class catch-all / Pramlintide

Listed sites

1

Recruiting sites

—

Enrollment

36

actual

Study population

Headache Disorders

Key I/E criterion

—

Primary endpoint

•Migraine incidence

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 IDNCT03598075
Org study IDH-17035931

Timeline

Milestones

Study start2018-07-01actual
Study first posted2018-07-26actual
Primary completion2019-09-30actual
Study completion2019-12-31actual
Last update posted2020-06-25actual

Assets

Investigational agents

GLP-1 / incretin class catch-allPramlintide

Study populations

Who this study enrolls

Headache Disorders

Eligibility

Who can enroll

Minimum age18 Years
Maximum age60 Years
SexAll
Healthy volunteersAccepted

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.

Endpoints (5)

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
3
Other clinical outcomes
1
Other (unclassified)
1

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Facial flushing

Time frame:2 hours

descriptive

Secondary/protocol endpoint

Plasma blood samples

Time frame:2 hours

concentration, descriptive

Secondary/protocol endpoint

Headache intensity

Time frame:12 hours

change from baseline, descriptive

Other clinical outcomes

1 endpoint
Primary/protocol endpoint

Migraine incidence

Time frame:12 hours

event count, event

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Dilatation of Arteria radialis and arteria temporalis superficialis

Time frame:2 hours

change from baseline, descriptive

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.