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NCT06848075
A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Treatment of Migraine
Phase 2 trial testing Elismetrep (K-304) Dose Level 1 in Acute Migraine in 431 participants. Completed in 11 August 2025.
11 August 2025
Quick facts
| Lead sponsor | Kallyope Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 431 |
| Start date | 5 March 2025 |
| Primary completion | 11 August 2025 |
| Estimated completion | 11 August 2025 |
| Sites | 66 locations across United States |
Drugs / interventions tested
- Elismetrep (K-304) Dose Level 1 — full drug profile →
- Elismetrep (K-304) Dose level 2 — full drug profile →
- Elismetrep (K-304) Dose level 3 — full drug profile →
- Elismetrep (K-304) Dose level 4 — full drug profile →
- Placebo
Conditions studied
- Acute Migraine — all drugs for Acute Migraine →
Sponsor
Kallyope Inc. — full company profile →
Who can join
Adults 18 to 70, any sex, with Acute Migraine. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a double-blind, randomized, multicenter, outpatient evaluation of the safety and efficacy of elismetrep as compared to placebo in the treatment of moderate or severe migraine.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06848075
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Kallyope Inc. trials
Trials by the same sponsor.
- NCT07116499 — A Study of K-645 in the Treatment of Multiple Migraine Attacks · Phase 2 · terminated
- NCT06305351 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-757 and K-833 in Overweight/Ob · Phase 1 · completed
- NCT06019559 — A Study to Evaluate the Safety, Tolerability, and Weight Loss Efficacy of K-757 Alone and in Combination With K-833 · Phase 2 · completed
- NCT05890950 — A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of K-757 and K-833 in Overweight/Obese Patients W · Phase 1 · completed
- NCT05900531 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-757 in Healthy Overweight/Obes · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06848075 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kallyope Inc.
- Last refreshed: 3 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06848075.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing