Condition or disease | Intervention/treatment | Phase |
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Dyskinesias Parkinson Disease | Drug: JM-010 group A Drug: JM-010 group B 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 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 (Clinical Trial) |
Estimated Enrollment : | 81 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Double-blind, double-dummy. |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | July 22, 2019 |
Estimated Primary Completion Date : | March 2022 |
Estimated Study Completion Date : | March 2022 |
Arm | Intervention/treatment |
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Experimental: JM-010 group A
As JM-010 4/0.8mg dose fixed combination drug(tablet) +Placebo 2
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Drug: JM-010 group A
JM-010 fixed combination drug(4/0.8mg) + Placebo 2
Other Name: JM-010
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Experimental: JM-010 group B
As JM-010 8/0.8mg dose fixed combination drug(tablet) + Placebo 1
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Drug: JM-010 group B
JM-010 fixed combination drug (8/0.8mg) + Placebo 1
Other Name: JM-010
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Placebo Comparator: Placebo
Double-dummy - 2 tablets = Placebo 1 +Placebo 2
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Drug: Placebos
Placebo 1 + Placebo 2
Other Name: Placebo
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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.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other criteria related to other medical conditions to be referred to the protocol.
Contact: Serena Hyun | 82-2-828-8114 | cp.e103@conterapharma.co.kr |
France | |
Contera Investigational site_FR | Recruiting |
Toulouse, France | |
Contact: Contera | |
Germany | |
Contera Investigational site_DE | Recruiting |
Rostock, Germany | |
Contact: Contera | |
Italy | |
Contera Investigational site_IT | Recruiting |
Roma, Italy | |
Contact: Contera | |
Spain | |
Contera Investigational site_ES | Recruiting |
Madrid, Spain | |
Contact: Contera |
Study Director: | Serena Hyun | Contera Pharma |
Tracking Information | |||||||
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First Submitted Date ICMJE | May 17, 2019 | ||||||
First Posted Date ICMJE | May 21, 2019 | ||||||
Last Update Posted Date | May 24, 2021 | ||||||
Actual Study Start Date ICMJE | July 22, 2019 | ||||||
Estimated Primary Completion Date | March 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
Efficacy of JM-010 to that of placebo therapy in reducing dyskinesia severity in PD: Unified Dyskinesia Rating Scale (UDysRS) [ Time Frame: 12 Weeks ] evaluating the mean change from Baseline to Week 12 through the Unified Dyskinesia Rating Scale (UDysRS).
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | A Study in Parkinson's Disease in Patients With Moderate to Severe Dyskinesia | ||||||
Official Title ICMJE | 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 | ||||||
Brief Summary | 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. | ||||||
Detailed Description |
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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking Description: Double-blind, double-dummy. Primary Purpose: Treatment
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA. J Parkinsons Dis. 2019;9(3):449-465. doi: 10.3233/JPD-199002. Review. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
81 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | March 2022 | ||||||
Estimated Primary Completion Date | March 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
Other criteria related to other medical conditions to be referred to the protocol. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | France, Germany, Italy, Spain | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03956979 | ||||||
Other Study ID Numbers ICMJE | JM-010CS03 2017-003415-19 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Bukwang Pharmaceutical ( Contera Pharma ) | ||||||
Study Sponsor ICMJE | Contera Pharma | ||||||
Collaborators ICMJE | Bukwang Pharmaceutical | ||||||
Investigators ICMJE |
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PRS Account | Bukwang Pharmaceutical | ||||||
Verification Date | May 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |