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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Alterity Clinical Trials
- Telefonnummer: +1 888-556-7582
- E-post: clinicaltrials@alteritytx.com
Studiesteder
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Midi-Pyrenees
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Toulouse, Midi-Pyrenees, Frankrike, 31300
- Hôpital Pierre-Paul Riquet
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New Aquitaine
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Bordeaux, New Aquitaine, Frankrike, 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, Frankrike, 13005
- Hôpital de la Timone
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Île-de-France Region
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Paris, Île-de-France Region, Frankrike, 75013
- Hôpital Universitaire Pitié Salpêtrière
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske 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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
|
Baseline to completion of study treatment, an average of 1 year.
|
|
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.
|
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.
|
Vital signs include blood pressure, pulse, temperature, and respiration rate.
|
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.
|
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.
|
Baseline to completion of study treatment, an average of 1 year.
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ATH434-203
- 2025-524317-88-00 (Ctis)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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