A Phase 2 Study of ONO-2808 in Patients With Multiple System Atrophy (NCT05923866) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Phase 2 Study of ONO-2808 in Patients With Multiple System Atrophy
United States92 participantsStarted 2023-09-22
Plain-language summary
This is a Phase 2, double-blind, parallel-group, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of multiple doses of ONO-2808 in patients with MSA. This is the first study of ONO-2808 in patients with MSA.
Who can participate
Age range30 Years – 80 Years
SexALL
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Inclusion criteria
✓. Female or male patients with a diagnosis of clinically-established or clinically-probable MSA according to the novel Movement Disorder Society (MDS) criteria for MSA diagnosis (2022), including patients with MSA of either subtype (MSA-P or MSA-C).
✓. Patients at the early stages of the disease, defined as a maximum of 5 years since the onset of one of the following symptoms associated with MSA:
✓. Patients with an anticipated survival of at least 3 years in the opinion of the Investigator.
✓. Patients who are able to ambulate without the assistance of another person, defined as the ability to take at least 10 steps and then to turn around and walk at least another 10 steps. Use of assistive devices (e.g., walker or cane) is allowed.
✓. Ability to swallow oral medication and be willing to adhere to the study intervention regimen.
Exclusion criteria
✕. Pregnant or lactating females.
✕. Patients with a clinically-significant or unstable medical or surgical condition other than MSA that, in the opinion of the Investigator, might preclude safe completion of the study or might affect the results of the study (e.g., pulmonary, cardiovascular \[including bradyarrhythmia\], macular edema, and significant renal or hepatic dysfunction).
✕. Neurological diseases/disorders other than MSA, such as Parkinson's disease, dementia with Lewy bodies, essential tremor, progressive supranuclear palsy, spinocerebellar ataxia, spastic paraparesis, corticobasal degeneration, or vascular, normal pressure hydrocephalus, pharmacological, or post-encephalitic parkinsonism.
What they're measuring
1
Incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
Timeframe: From screening up to follow-up for the core part and for the extension part (up to Week 92)
2
Vital signs (blood pressure)
Timeframe: From screening up to follow-up for the core part and for the extension part (up to Week 92)
3
Vital signs (pulse rate)
Timeframe: From screening up to follow-up for the core part and for the extension part (up to Week 92)
4
Vital signs (temperature)
Timeframe: From screening up to follow-up for the core part and for the extension part (up to Week 92)
5
Vital signs (respiratory rate)
Timeframe: From screening up to follow-up for the core part and for the extension part (up to Week 92)
6
12-lead electrocardiograms (ECGs); parameters such as, but not limited to, heart rate, RR, PR, QRS, QT, and corrected QT intervals (QTcF)
Timeframe: From screening up to follow-up for the core part and for the extension part (up to Week 92)
. Patients with documented liver diseases or cirrhosis.
✕. Positive results at Screening for active viral infections that include positive human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) and hepatitis B core antibody, and hepatitis C virus (HCV).
✕. Patients with suicide ideation according to the Investigator's clinical judgment per the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening or who have made a suicide attempt in the 6 months before Screening.
Timeframe: From screening up to follow-up for the core part and for the extension part (up to Week 92)
8
Clinical laboratory abnormalities (hematology, clinical chemistry, and urinalysis)
Timeframe: From screening up to follow-up for the core part and for the extension part (up to Week 92)
9
Clinically-abnormal findings in the Columbia Suicide Severity Rating Scale (C-SSRS)
Timeframe: From screening up to follow-up for the core part and for the extension part (up to Week 92)