Open-Label Access to ATH434 for Patients Who Completed Study ATH434-201 in France

Официальное название

Open-Label Extension Study to Provide Access to ATH434 in Patients With Multiple System Atrophy

Обзор

This multicenter open-label extension study conducted in France is designed to provide ATH434 orally BID to eligible patients who completed the Phase 2 study ATH434-201, and who may benefit from this treatment according to the evaluation by the Investigator.

Подробное описание

This is a multicenter, open-label extension (OLE) study designed to provide continued access to the investigational product ATH434 for eligible participants with Multiple System Atrophy (MSA) who have successfully completed the prior Phase 2 clinical trial (ATH434-201) in France. Up to 5 participants will be enrolled. No new participants will be recruited or enrolled in this study.

The primary objective is to monitor long-term safety, tolerability, and clinical response. Eligible participants will receive ATH434 at a dose of 75 mg twice daily (BID) to be taken with food.

The study is divided into two operational phases:

Initial Treatment Phase: Participants will receive treatment for a planned duration of 12 months.

Extension Phase: Participants may continue treatment beyond the initial 12 months based on the investigator's clinical judgment of ongoing benefit, safety, and tolerability. Continued eligibility will be re-evaluated and documented every 3 months.

Participants will undergo a combination of in-clinic and remote visits to perform safety monitoring, clinical evaluations, and investigational product accountability.

Вмешательства

• Препарат ATH434
  ATH434 75 mg tablets administered orally twice daily (BID).

Первичные конечные точки

• Incidence, Severity, and Relationship of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: Baseline to completion of study treatment, an average of 1 year.]
• Change From Baseline in Clinical Laboratory Parameters [Срок оценки: Baseline to completion of study treatment, an average of 1 year.]
• Change From Baseline in Vital Signs [Срок оценки: Baseline to completion of study treatment, an average of 1 year.]
• Duration of Exposure to ATH434 [Срок оценки: Baseline to completion of study treatment, an average of 1 year.]
• Cumulative Dose of ATH434 [Срок оценки: Baseline to completion of study treatment, an average of 1 year.]

Критерии участия

Критерии включения

• Completed Alterity protocol ATH434-201.
• Expected to benefit from treatment from treatment with ATH434, in the opinion of the Investigator.

Критерии исключения

• Discontinued prior ATH434 treatment (ATH434-201) for any reason.
• Significant medical or psychiatric condition that may decrease the benefit-risk ratio of participation in this program to an unacceptable level, as per the Investigator's opinion.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 4 центра

• Hôpital Pierre-Paul Riquet — Toulouse
• Centre Hospitalier Universitaire de Bordeaux — Bordeaux
• Hôpital de la Timone — Marseille
• Hôpital Universitaire Pitié Salpêtrière — Paris

Идентификаторы

NCT: NCT07729852 · ATH434-203 · 2025-524317-88-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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