Health TrialsbyHealthPanel

A Trial of ONO-2808 in Participants With the Parkinsonian Subtype of Multiple System Atrophy (MSA-P)

ConditionMultiple System Atrophy, Parkinson Variant
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age30-80
SponsorOno Pharmaceutical Co., Ltd.

About this trial

The main goal of this clinical trial is to learn if ONO-2808 works to treat adults with the Parkinsonian subtype of Multiple System Atrophy (MSA-P). Researchers will compare ONO-2808 to a placebo (a look-alike substance that contains no drug) to see if ONO-2808 works to treat MSA-P.

Participants will:

* Take ONO-2808 or placebo orally for up to 48 weeks * Make visits to the clinic for checkups and tests * Answer questions about their health throughout the trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants with a diagnosis of clinically established or clinically probable MSA-P according to the 2022 Movement Disorder Society (MDS) criteria for MSA diagnosis.

Parkinsonism

Orthostatic hypotension

Urinary dysautonomia

Disqualifiers

Participants with the cerebellar subtype of MSA according to the 2022 MDS criteria for MSA diagnosis.

Female participants who are pregnant, planning to become pregnant during the study, or breastfeeding.

Participants with a clinically significant or unstable medical or surgical condition other than MSA-P that, in the opinion of the Investigator, might preclude safe completion of the study or might affect the results of the study (eg, pulmonary, cardiovascular [including bradyarrhythmia], macular edema, and significant renal or hepatic dysfunction).

Neurological diseases/disorders other than MSA-P, 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 postencephalitic parkinsonism.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ONO-2808

    Drug

    ONO-2808 will be administered to participants orally once daily for 48 weeks.

  • Placebo

    Other intervention

    Matching placebo will be administered to participants orally once daily for 48 weeks.

Treatment groups

486 Participants
are divided into 3 treatment groups
Group A: ONO-2808 Low DoseExperimental treatment 1 intervention
Group B: ONO-2808 High DoseExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in modified United Multiple System Atrophy Rating Scale (mUMSARS) Part I (excluding Item 11) with Collapsed Scoring (0-3)

Time frame
Baseline, Week 48

Secondary outcomes

1

Change from Baseline in Multiple System Atrophy Quality of Life Scale (MSA-QoL) Motor Subscale Score

Time frame
Baseline, Week 48
2

Change from Baseline in Magnetic Resonance Imaging (MRI) Volumetric Assessments

Time frame
Baseline, Week 48
3

Change from Baseline in Total United Multiple System Atrophy Rating Scale (UMSARS) Score (Part I and Part II, all items)

Time frame
Baseline, Week 48
4

Change from Baseline in mUMSARS Score

Time frame
Baseline, Week 48

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ono Pharmaceutical Co., Ltd.

Lead sponsor

Deciphera Pharmaceuticals, LLC

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: