A Study in Parkinson's Disease in paTients With mOderate to seveRe dyskInesiA (ASTORIA)
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|ClinicalTrials.gov Identifier: NCT03956979|
Recruitment Status : Not yet recruiting
First Posted : May 21, 2019
Last Update Posted : June 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Dyskinesias||Drug: JM-010 A group Drug: JM-010 B group Drug: Placebos||Phase 2|
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 buspirone and zolmitriptan (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 2weeks, including pharmacokinetic (PK) sub-study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||81 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Double-blind, double-dummy.|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study in Parkinson's Disease Patients With Moderate to Severe Dyskinesia to Assess the Efficacy and Safety/Tolerability of Two Dose Combinations of JM-010|
|Estimated Study Start Date :||July 2019|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||June 2021|
Experimental: JM-010 A group
As JM-010 4/0.8mg dose fixed combination drug(tablet) +Placebo 2
Drug: JM-010 A group
JM-010 fixed combination drug(4/0.8mg) + Placebo 2
Other Name: JM-010
Experimental: JM-010 B group
As JM-010 8/0.8mg dose fixed combination drug(tablet) + Placebo 1
Drug: JM-010 B group
JM-010 fixed combination drug (8/0.8mg) + Placebo 1
Other Name: JM-010
Placebo Comparator: Placebo
Double-dummy - 2 tablets = Placebo 1 +Placebo 2
Placebo 1 + Placebo 2
Other Name: Placebo
- Unified Dyskinesia Rating Scale (UDysRS) [ Time Frame: 12 Weeks ]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.
- Unified Dyskinesia Rating Scale (UDysRS) [ Time Frame: 2 Weeks, 4 Weeks, 8 Weeks ]To compare the efficacy of JM-010 to that of placebo therapy by evaluating the total score changes from Baseline to Weeks 2, 4, 8 in the sum of the items comprising UDysRS, dyskinesia rating scale from 0-104. Higher score means more dyskinesia.
- Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [ Time Frame: 2 Weeks, 4 Weeks, 8 Weeks, 12 Weeks ]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.
- Clinician's Global Impression-Change (CGI-C) score [ Time Frame: 12 Weeks ]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.
- Hauser diary [ Time Frame: 2 Weeks, 4 Weeks, 8 Weeks, 12 Weeks ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956979
|Contact: Jihyeon Kimfirstname.lastname@example.org|
|Contact: Minjung Wooemail@example.com|
|Principal Investigator:||Alexander Storch, PhD. Dr.||Universitätsklinik Rostock - Hospital|