Investigation of Cogane (PYM50028) in early stage Parkinson's disease

INTERVENTION: Product Name: PYM50028 Product Code: PYM50028 Pharmaceutical Form: Oral solution INN or Proposed INN: SMILAGENIN CAS Number: 126‐18‐1 Current Sponsor code: PYM50028 Other descriptive name: (3ß, 5ß, 25R)‐spirostan‐3‐ol Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 3‐ Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use Product Name: PYM50028 Product Code: PYM50028 Pharmaceutical Form: Oral solution INN or Proposed INN: SMILAGENIN CAS Number: 126‐18‐1 Current Sponsor code: PYM50028 Other descriptive name: (3ß, 5ß, 25R)‐spirostan‐3‐ol Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6‐ Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use Product Name: PYM50028 Product Code: PYM50028 Pharmaceutical Form: Oral solution INN or Proposed INN: SMILAGENIN CAS Number: 126‐18‐1 Current Sponsor code: PYM50028 Other descriptive name: (3ß, 5ß, 25R)‐spirostan‐3‐ol Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 9‐ Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use CONDITION: Early‐Stage Parkinson’s Disease ; MedDRA version: 15.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 ‐ Nervous system disorders Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: To determine whether PYM50028 exhibits clinical benefit in the treatment of subjects with early‐stage Parkinson’s disease (PD), as assessed by the Unified Parkinson’s Disease Rating Scale score for Parts II and III combined (UPDRS II/III), compared with placebo. Primary end point(s): The primary efficacy endpoint of this study is the change in UPDRS II/III score between baseline and Week 28. Secondary Objective: To evaluate the efficacy of PYM50028 compared with placebo on other aspects of PD and to assess safety, tolerability and plasma concentration of PYM50028 in the treatment of early‐stage PD. Timepoint(s) of evaluation of this end point: Week 28; SECONDARY OUTCOME: Secondary end point(s): Assess any dose‐response relationship; time to symptomatic PD therapy; ; change in SCOPA‐COG total score between baseline and Week 28; ; change in PDQ‐39 scores for each domain and total score between ; baseline and Weeks 12 and 28; ; change in ESS total score between baseline and Week 28; ; change in NMSS scores for each domain and total score between ; baseline and Week 28. Timepoint(s) of evaluation of this end point: Week 12 and/or Week 28 ; INCLUSION CRITERIA: 1. Subjects must provide written informed consent prior to any study procedures being performed. 2. Subjects must be able to understand the study requirements and be able and willing to follow any instructions and comply with all scheduled study visits. 3. Male or female subjects aged between 35 and 75 years, inclusive at the time of consent. 4. Subjects must have a confirmed diagnosis of early‐stage idiopathic PD according to the UK PD Society Brain Bank (UKPDSBB) criteria within the 2 years prior to screening. 5. Subjects must have a Hoehn and Yahr Score of 1 to 2.5, inclusive and no postural instability. 6. Subjects whose clinical condition at the time of study enrolment does not require any PD therapy and, to the investigator's best judgment, will not require such therapy for the next 6 months. 7. Female subjects must be of non‐child bearing potential: post‐menopausal (no menses in the past 12 months and