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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
Kontakter och platser
Studiekontakt
- Namn: Alterity Clinical Trials
- Telefonnummer: +1 888-556-7582
- E-post: clinicaltrials@alteritytx.com
Studieorter
-
-
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
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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).
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence, Severity, and Relationship of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsram: 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
Tidsram: 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.
|
|
Change From Baseline in Vital Signs
Tidsram: 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.
|
|
Duration of Exposure to ATH434
Tidsram: 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.
|
|
Cumulative Dose of ATH434
Tidsram: 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.
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ATH434-203
- 2025-524317-88-00 (Ctis)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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