acetaminophen/naltrexone (ALLOD-2) / Allodynic - LARVOL DELTA

Single-Site Study of Naltrexone/Acetaminophen for the Acute Treatment of Migraine: A Phase 2 Randomized Trial (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Allodynic Therapeutics, Inc | Not yet recruiting ➔ Recruiting | Trial completion date: Jul 2026 ➔ Dec 2026 | Trial primary completion date: Jul 2026 ➔ Dec 2026

Enrollment open • Trial completion date • Trial primary completion date • CNS Disorders • Migraine • Pain

Multi-Center Study of Naltrexone-Acetaminophen in Acute Migraine, With an Exploratory Analysis of Co-occurring Anxiety (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: Allodynic Therapeutics, Inc | Trial completion date: Jul 2025 ➔ Jul 2026 | Trial primary completion date: Mar 2025 ➔ Jul 2026

Trial completion date • Trial primary completion date • CNS Disorders • Migraine • Mood Disorders • Pain • Psychiatry

ANODYNE-1: An Acute Migraine Factorial Study (clinicaltrials.gov) - P2 | N=92 | Completed | Sponsor: Allodynic Therapeutics, Inc

New P2 trial • CNS Disorders • Migraine • Pain

Multi-Center Study of Naltrexone-Acetaminophen in Acute Migraine, With an Exploratory Analysis of Co-occurring Anxiety (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: Allodynic Therapeutics, Inc | Trial completion date: Nov 2024 ➔ Jul 2025 | Trial primary completion date: Sep 2024 ➔ Mar 2025

Trial completion date • Trial primary completion date • CNS Disorders • Migraine • Mood Disorders • Pain • Psychiatry

A Phase 2 Study Evaluating Naltrexone-Acetaminophen in Acute Migraine and Co-Occurring Anxiety in Adults (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: Annette C. Toledano MD | N=435 ➔ 300 | Trial completion date: May 2024 ➔ Nov 2024 | Initiation date: Aug 2023 ➔ Jan 2024 | Trial primary completion date: May 2024 ➔ Sep 2024

Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date • CNS Disorders • Migraine • Mood Disorders • Pain • Psychiatry

Naltrexone-Acetaminophen Combination in the Treatment of Acute Migraine and Co-Occurring Anxiety in Adults (clinicaltrials.gov) - P2 | N=360 | Not yet recruiting | Sponsor: Allodynic Therapeutics, LLC | Initiation date: May 2023 ➔ Aug 2023

Trial initiation date • CNS Disorders • Migraine • Mood Disorders • Pain • Psychiatry

ANODYNE-2: Low-Dose Naltrexone and Acetaminophen Combination and Sumatriptan in the Acute Treatment of Migraine With Nausea (clinicaltrials.gov) - P2/3; N=36; Completed; Sponsor: Allodynic Therapeutics, LLC; Phase classification: P2b ➔ P2/3

Phase classification • CNS Disorders • Migraine

ANODYNE-3t: The Preventive Treatment of Migraine With Low-Dose Naltrexone and Acetaminophen Combination (clinicaltrials.gov) - P2; N=12; Completed; Sponsor: Allodynic Therapeutics, LLC; Active, not recruiting ➔ Completed; Phase classification: P2b ➔ P2

Phase classification • Trial completion • CNS Disorders • Migraine

ANODYNE-4t: Twice Daily Oral ALLOD-2 vs. Placebo in the Treatment of Chronic Low Back Pain (ANODYNE-4) (clinicaltrials.gov) - P2b; N=12; Completed; Sponsor: Allodynic Therapeutics, LLC; Active, not recruiting ➔ Completed

Clinical • Trial completion