The current study will explore the efficacy, safety and tolerability of 2 dose combinations of JM-010 to determine the optimal doses of each component to be studied in confirmatory clinical trials.
This is a Phase 2, double-blind, double-dummy, placebo-controlled, randomized, parallel group, multicentre study. Subjects with a diagnosis of moderate to severe dyskinesia in Parkinson's disease (PD) will complete a Screening Visit to assess eligibility to participate in the study. Subjects will continue with their usual levodopa treatment regimen for the duration of study participation. The screening assessment period will be a minimum of 1 week up to a maximum of 6 weeks. Subjects deemed to be eligible at the end of the Screening Visit will be randomly assigned in a 1:1:1 ratio to receive either 1 of the 2 dose combinations of JM-010 and 1 placebo, or 2 placebos as per the double-dummy study design. The randomized subjects will be followed treatment periods for 12 weeks and safety follow periods for 2 weeks, including pharmacokinetic (PK) sub-study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
89
JM-010 fixed combination drug (Group A) + Placebo 2
JM-010 fixed combination drug (Group B) + Placebo 1
Placebo 1 + Placebo 2
Contera Investigational site_FR
Toulouse, France
Contera Investigational site_DE
Rostock, Germany
Contera Investigational site_IT
Roma, Italy
Contera Investigational site_KOR
Seoul, South Korea
Contera Investigational site_ES
Unified Dyskinesia Rating Scale (UDysRS)
To compare the efficacy of JM-010 to that of placebo therapy in reducing dyskinesia severity in Parkinson's Disease by evaluating the total score mean change from Baseline to Week 12 in the sum of the items comprising UDysRS. The scoring range is 0-104, and a higher score indicates more severe dyskinesia.
Time frame: 12 Weeks
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
To compare the efficacy of JM-010 to that of placebo therapy as measured by the sum of the MDS-UPDRS Part III score changes from Baseline to Weeks 2, 4, 8, 12. The score range is 0-132, where a higher score means more severe motor impairment.
Time frame: 2 Weeks, 4 Weeks, 8 Weeks, 12 Weeks
Clinician's Global Impression-Change (CGI-C) score
To compare the efficacy of JM-010 to that of placebo therapy in relation to improvement in clinician-reported PD symptoms as measured by CGI-C score at Week 12. The CGI-C uses the following ratings: 0=not assessed; 1=very much improved; 2=much improved; 3=a little improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse.
Time frame: 12 Weeks
Hauser diary
To compare the efficacy of JM-010 to that of placebo therapy as measured by ON time without troublesome dyskinesia changes, OFF time changes, ON time with troublesome dyskinesia changes, Total time with dyskinesia changes from Baseline to Week 2, 4, 8, 12 in Hauser diary
Time frame: 2 Weeks, 4 Weeks, 8 Weeks, 12 Weeks
Unified Dyskinesia Rating Scale (UDysRS)
To compare the efficacy of JM-010 to that of placebo therapy in reducing dyskinesia severity in Parkinson's Disease by evaluating the total score mean change from Baseline to Week 2, 4, 8. The scoring range is 0-104, and a higher score indicates more severe dyskinesia.
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Madrid, Spain
Time frame: 2 Weeks, 4 Weeks, 8 Weeks