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Protocol number: CLT-NVX-2025-01

PROTOCOL INFORMATION FOR CANADIAN SITES ONLY

Clinical Trial Protocol 01

Version date: 24-MAR-2025

Protocol Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Neravex (CLT-105) in Adults with Generalized Anxiety Disorder (GAD)

Cover Page
SPONSOR ADDRESS

Clarion Therapeutics

123 Road St East

Toronto, Ontario, Canada

A1A 1A1

Medical Advisor

Sousa, Michael

Tel: +1-416-555-5555

Section 5.2

EXCLUSION CRITERIA

Subjects meeting any of the following criteria will be excluded from participation in this study:

1. Current diagnosis of Major Depressive Disorder (MDD) with active depressive episode within 6 months prior to screening
2. History of bipolar I or II disorder, schizophrenia, schizoaffective disorder, or other psychotic disorder
3. Active suicidal ideation as measured by a score ≥ 4 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening
4. Known hypersensitivity or allergy to CLT-105 or any of its excipients
5. Use of prohibited medications including MAOIs, benzodiazepines, or other anxiolytics within 14 days of randomization
6. Clinically significant abnormalities on ECG, laboratory tests, or physical examination at screening
7. Pregnant or breastfeeding women, or women of childbearing potential not using adequate contraception

Your AI Protocol Expert

Welcome to the Protocol AI — your interactive guide to navigating your trial protocol. Ask questions and uncover insights quickly.

What are the exclusion criteria?

Based on Section 5.2 of the protocol, the key exclusion criteria are:

  • Current diagnosis of Major Depressive Disorder (MDD)
  • History of bipolar, schizophrenia, or psychotic disorders
  • Active suicidal ideation (C-SSRS score ≥ 4)
  • Known hypersensitivity to CLT-105
  • Use of prohibited medications (MAOIs, benzodiazepines) within 14 days

Referenced from page 8, Section 5.2

Ask anything... What are the exclusion criteria?

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