5,7-dichloro-2-((ethylamino)methyl)-8-hydroxy-3-methylquinazolin-4(3h)-one methanesulfonate for Multiple system atrophy

Inclusion criteria

• {"criterion_text":"- Completed the ATH434-201 study in accordance with the study protocol requirements."}
• {"criterion_text":"- Willing and able to provide written informed consent prior to any study-related procedure."}
• {"criterion_text":"- Able to attend scheduled study visits (clinic and remote) as specified in the Schedule of Events."}
• {"criterion_text":"- Expected, in the investigator’s judgement, to benefit from treatment with ATH434."}
• {"criterion_text":"- Female participants must meet one of the following criteria: • Postmenopausal (defined as ≥12 months of spontaneous amenorrhea with a serum follicle stimulating hormone [FSH] level consistent with postmenopausal status at screening, or • Surgically sterile (documented hysterectomy, bilateral oophorectomy, or bilateral salpingectomy performed ≥6 months prior to enrollment), or • Of childbearing potential and compliant with the contraception requirements described in Section 7.4.2."}
• {"criterion_text":"- Male participants must agree to comply with the contraception requirements described in Section 7.4.3."}

Exclusion criteria

• {"criterion_text":"- Discontinued prior ATH434-201 treatment for any reason."}
• {"criterion_text":"- Any medical condition or psychiatric condition that, in the opinion of the investigator, results in an unfavorable benefit–risk ratio with ATH434 treatment. This includes but is not limited to: • Hemoglobin (male <13 g/dL; female <11 g/dL); • Abnormal liver tests: ALT and/or AST > 3 × ULN or Total bilirubin > 1.5 x ULN; • Renal impairment: creatinine clearance < 50 mL/min, as estimated by the Cockcroft–Gault formula; • Other clinically relevant abnormalities considered significant by the Investigator."}
• {"criterion_text":"- History of certain neurological event or abnormalities."}
• {"criterion_text":"- Use of prohibited concomitant medications that can interfere with ATH434 metabolism. (See Section 7.1)."}
• {"criterion_text":"- Known hypersensitivity to ATH434 or to any excipient in the formulation."}
• {"criterion_text":"- Pregnant or breastfeeding women or planning to become pregnant or breastfeeding while participating in the study."}
• {"criterion_text":"- Participated in an interventional medical research study/program within 30 days or 5 drug half-lives, whichever is longer, at the time of enrollment, or planning to do so while participating in the study."}

Primary endpoints

• {"endpoint_text":"- Assessment of long term safety and tolerability based on incidence and severity of AEs and SAEs, changes in laboratory and vital sign parameters including orthostatic measures, exposure to ATH434, treatment discontinuations due to adverse events, and deaths.","definition_or_measurement_approach":"Assessment based on incidence and severity of adverse events (AEs) and serious adverse events (SAEs), changes in laboratory and vital sign parameters (including orthostatic measures), exposure to ATH434, treatment discontinuations due to adverse events, and deaths."}

France

Earliest CTIS Part Ii Submission Date

14-04-2026

Latest Decision Or Authorization Date

13-05-2026

Processing Time Days

29

Number Of Sites

4

Number Of Participants

7

Primary sponsor

Full Name

Alterity Therapeutics Limited

Organisation Type

Pharmaceutical company

Country Of Registered Address

Australia

Contract research organisations

Name

Wep Clinical Ireland Limited

Responsibilities

Sponsor duties codes: 1,12,13,14,5,6,8; contact Bwhite@wepclinical.com

Third parties

• {"country":"Ireland","full_name":"Wep Clinical Ireland Limited","duties_or_roles":"Sponsor duties codes: 1,12,13,14,5,6,8","organisation_type":"Pharmaceutical company"}