Clinical Trials

Inclusion Criteria:

• Diagnosis of possible or probable MSA of the parkinsonian sub-type (MSA-P) or cerebellar sub-type (MSA-C) according to the Gilman criteria at the Screening Visit.
• Less than 5 years from the time of onset of motor and/or autonomic (orthostatic or urinary) MSA symptoms at the Screening Visit in the judgement of the investigator.
• Anticipated survival of at least 3 years, in the opinion of the investigator, at the Screening Visit.
• An UMSARS Part I score ≤ 16 (omitting question 11 on sexual function) at the Screening Visit.
• Cognitive performance evaluated by the Montreal Cognitive Assessment (MoCA) with a score ≥ 22 at the Screening Visit.
• The patient has a knowledgeable and reliable caregiver who will be available throughout the study when carer/observer-reported outcomes are performed. A caregiver is defined as a person who spends approximately 3 hours or more with the patient per week and can inform on level of function of the patient.
• Aged ≥ 40 and ≤ 75 years at the Screening Visit.

Exclusion Criteria:

• Treatment with an anti-α-synuclein monoclonal antibody or an inhibitor of α-synuclein aggregation within the last 12 months.
• Any past or current treatment with an active vaccine targeting α-synuclein.
• The patient has two or more blood relatives with a history of MSA.
• The patient meets any of the following criteria at the Screening Visit, which suggests advanced disease:
  • Speech impairment, as assessed by a score of ≥ 3 on UMSARS Part I question 1;
  • Swallowing impairment, as assessed by a score of ≥ 3 on UMSARS Part I question 2;
  • Impairment in ambulation, as assessed by a score of ≥ 3 on UMSARS Part I question 7;
  • Falling more frequently than once per week, as assessed by a score of ≥ 3 on UMSARS Part I question 8;
  • Evidence (clinically or on MRI) and/or history of any serious neurological disorder, other intracranial or systemic diseases or conditions resulting in a diagnosis other than MSA;
  • Current diagnosis of movement disorders that could mimic MSA; e.g., Parkinson’s disease, dementia with Lewy bodies, essential tremor, progressive supranuclear palsy, spinocerebellar ataxia, spastic paraparesis, corticobasal degeneration, or vascular, pharmacological or post-encephalitic parkinsonism, per investigator discretion. Patients who have previously been diagnosed with Parkinson’s disease will not be excluded;
  • History of severe drug allergy, anaphylaxis or hypersensitivity or known hypersensitivity or intolerance to the IMP or its excipients;
  • History of neurosurgical procedures including deep brain stimulation that could, in the investigator’s opinion, interfere with the assessments of safety or efficacy;
  • Contraindications for MRI;
  • Attempted suicide within the past 6 months or is at significant risk of suicide (either in the opinion of the investigator or defined as a “yes” to suicidal ideation questions 4 or 5 or answering “yes” to suicidal behaviour on the C-SSRS within the past 6 months).
• The following recent and concomitant medications are disallowed or allowed with restrictions with respect to their use prior to or during the study (the list is not comprehensive):
  • Disallowed: any investigational products within 30 days before the baseline assessment, treatment targeting α-synuclein and/or MSA disease progression;
  • Allowed with restriction: stable dose for at least 8 weeks prior to randomization of drugs acting against parkinsonism (e.g., Levodopa, Dopamine-Agonists, Amantadine and MAO-B-Inhibitors) and/or drugs acting against autonomic dysfunction (e.g., ephedrine, droxidopa, midodrine, fludrocortisone, octreotide, desmopressin, oxybutynin) and anticipated stable during the double-blinded period. If medically necessary, initiation of or change of dose of concomitant medication is allowed per investigator discretion.

Eligibility last updated 8/16/21. Questions regarding updates should be directed to the study team contact.