Open-Label Access to ATH434 for Patients Who Completed Study ATH434-201 in France
Open-Label Extension Study to Provide Access to ATH434 in Patients With Multiple System Atrophy
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Alterity Clinical Trials
- Telefonnummer: +1 888-556-7582
- E-mail: clinicaltrials@alteritytx.com
Studiesteder
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Midi-Pyrenees
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Toulouse, Midi-Pyrenees, Frankrig, 31300
- Hôpital Pierre-Paul Riquet
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New Aquitaine
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Bordeaux, New Aquitaine, Frankrig, 33076
- Centre Hospitalier Universitaire De Bordeaux
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Provence-Alpes-Côte d'Azur Region
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Marseille, Provence-Alpes-Côte d'Azur Region, Frankrig, 13005
- Hôpital de la Timone
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Île-de-France Region
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Paris, Île-de-France Region, Frankrig, 75013
- Hôpital Universitaire Pitié Salpêtrière
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Completed Alterity protocol ATH434-201.
- Expected to benefit from treatment from treatment with ATH434, in the opinion of the Investigator.
Exclusion Criteria:
- 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: ATH434 75mg BID
Participants who completed the prior ATH434-201 Phase 2 trial will receive ATH434 75 mg orally twice daily (BID).
Treatment consists of an initial 12-month treatment phase, followed by an ongoing extension phase based on investigator assessment of continued clinical benefit, safety, and tolerability
|
ATH434 75 mg tablets administered orally twice daily (BID).
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence, Severity, and Relationship of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Baseline to completion of study treatment, an average of 1 year.
|
All AEs will be reviewed at every participant contact and documented in the CRF.
All SAEs will be reported within 24 hours of awareness in accordance with local regulatory requirements.
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Baseline to completion of study treatment, an average of 1 year.
|
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Change From Baseline in Clinical Laboratory Parameters
Tidsramme: Baseline to completion of study treatment, an average of 1 year.
|
Clinical laboratory parameters include hematology and blood chemistry panels.
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Baseline to completion of study treatment, an average of 1 year.
|
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Change From Baseline in Vital Signs
Tidsramme: Baseline to completion of study treatment, an average of 1 year.
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Vital signs include blood pressure, pulse, temperature, and respiration rate.
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Baseline to completion of study treatment, an average of 1 year.
|
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Duration of Exposure to ATH434
Tidsramme: Baseline to completion of study treatment, an average of 1 year.
|
Total duration of treatment with investigational product per participant.
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Baseline to completion of study treatment, an average of 1 year.
|
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Cumulative Dose of ATH434
Tidsramme: Baseline to completion of study treatment, an average of 1 year.
|
Total cumulative dose of investigational product administered per participant.
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Baseline to completion of study treatment, an average of 1 year.
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ATH434-203
- 2025-524317-88-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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