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IHL-42X Low Dose · REPOSA

RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA

Ensayo de Incannex Healthcare Inc. en Apnea obstructiva del sueno.

Más ensayos de: Apnea obstructiva del sueño.

Fase

Fase 2/3

Estado

Completado

Participantes

121

previstos

Centros

20

Fin del objetivo primario

may 2025

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en may 2024.

Qué mide

Cambio en el indice de apnea-hipopnea (AHI) (4 semanas)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe goal of this randomised, double-blind phase II/III clinical trial is to determine the safety and efficacy of IHL-42X in subjects with obstructive sleep apnoea who are intolerant, non-compliant, or naïve to positive airway pressure. Phase II study will be a 4-week dose-finding study comparing two dose strengths of IHL-42X to placebo. The optimal dose strength will be selected based on comparing the safety and efficacy of the two IHL-42X dose strengths to placebo over a 4-week treatment period. The three treatment groups are; IHL-42X Low dose (2.5mg dronabinol, 125mg acetazolamide), IHL-42X High dose (5mg dronabinol, 250mg acetazolamide) and Placebo. Each treatment group will enrol approximately 40 patients per treatment arm, for a total of approximately 120 patients. The safety and efficacy results of the Phase II study will be used to select the dose strength of IHL-42X and corresponding doses of dronabinol and acetazolamide in Phase III. Phase III study will use the optimal dose strength of IHL-42X identified in Phase II and will be compared to the component active pharmaceutical ingredients at equivalent dose strengths to those found in the IHL-42X optimal dose strength and placebo over 52 weeks. The four treatment groups are; IHL-42X (optimal dose from Phase II), Acetazolamide (equivalent dose strength to that in the IHL-42X optimal dose strength), Dronabinol (equivalent dose strength to that in the IHL-42X optimal dose strength) and placebo. The treatment groups will enrol approximately 165 patients in IHL-42X, approximately 55 patients in dronabinol, approximately 55 in acetazolamide, and approximately 165 in placebo, for a total of approximately 440 patients.

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Todos los de IXHL, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT06146101), actualizada en jul 2026.