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A Study in Parkinson's Disease in Patients With Moderate to Severe Dyskinesia (ASTORIA)

Primary Purpose

Dyskinesias

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
JM-010 group A
JM-010 group B
Placebos
Sponsored by
Contera Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyskinesias

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Is able to read, understand, and provide written, dated informed consent prior to Screening Visit.
  • Is male or female, between 18 and 80 years of age at Screening Visit.
  • Is diagnosed with idiopathic PD that meets UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria and requires treatment with and shows responsiveness to levodopa.
  • Has experienced dyskinesia over a period of at least 3 months prior to Screening Visit
  • Has stable peak-effect dyskinesia
  • Has more than one hour of "ON" time with troublesome dyskinesia during daily waking hours on a 24-hour PD subject diary
  • Is on a stable levodopa dosing regimen requiring at least 3 dose administrations but no more than 6 dose administrations per day

Exclusion Criteria:

  • Has undergone surgery for the treatment of PD
  • Has a current diagnosis of Substance Use (including alcohol) Disorder (Abuse or Dependence, as defined by Diagnostic and Statistical Manual, Fifth Edition [DSM 5]),
  • Has psychiatric diagnosis of acute psychotic disorder or other psychiatric diagnoses
  • Has a significant risk for suicidal behaviour in the opinion of the investigator during the course of their participation in the study
  • Has current seizure disorders (other than febrile seizures in childhood) requiring treatment with anticonvulsants.
  • Has known serious ongoing symptomatic cerebral disease or cerebrovascular disease or any acute brain trauma requiring treatment with anti-convulsant therapy within 5 years prior Visit 2, Week 0 (Baseline Visit).
  • Has a history of exclusively diphasic, OFF state, myoclonic, dystonic, or akathetic dyskinesia without peak-dose dyskinesia.

Other criteria related to other medical conditions to be referred to the protocol.

Sites / Locations

  • Contera Investigational site_FRRecruiting
  • Contera Investigational site_DERecruiting
  • Contera Investigational site_ITRecruiting
  • Contera Investigational site_ESRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

JM-010 group A

JM-010 group B

Placebo

Arm Description

Group A (JM-010 dose fixed combination drug(tablet)) +Placebo 2

Group B (JM-010 8/0.8mg dose fixed combination drug(tablet)) + Placebo 1

Double-dummy - 2 tablets = Placebo 1 +Placebo 2

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
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.

Full Information

First Posted
May 17, 2019
Last Updated
August 23, 2022
Sponsor
Contera Pharma
Collaborators
Bukwang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT03956979
Brief Title
A Study in Parkinson's Disease in Patients With Moderate to Severe Dyskinesia
Acronym
ASTORIA
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Contera Pharma
Collaborators
Bukwang Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyskinesias

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind, double-dummy.
Allocation
Randomized
Enrollment
81 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
JM-010 group A
Arm Type
Experimental
Arm Description
Group A (JM-010 dose fixed combination drug(tablet)) +Placebo 2
Arm Title
JM-010 group B
Arm Type
Experimental
Arm Description
Group B (JM-010 8/0.8mg dose fixed combination drug(tablet)) + Placebo 1
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Double-dummy - 2 tablets = Placebo 1 +Placebo 2
Intervention Type
Drug
Intervention Name(s)
JM-010 group A
Other Intervention Name(s)
JM-010
Intervention Description
JM-010 fixed combination drug (Group A) + Placebo 2
Intervention Type
Drug
Intervention Name(s)
JM-010 group B
Other Intervention Name(s)
JM-010
Intervention Description
JM-010 fixed combination drug (Group B) + Placebo 1
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
Placebo
Intervention Description
Placebo 1 + Placebo 2
Primary Outcome Measure Information:
Title
Unified Dyskinesia Rating Scale (UDysRS)
Description
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
Secondary Outcome Measure Information:
Title
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Description
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
Title
Clinician's Global Impression-Change (CGI-C) score
Description
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
Title
Hauser diary
Description
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
Title
Unified Dyskinesia Rating Scale (UDysRS)
Description
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.
Time Frame
2 Weeks, 4 Weeks, 8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is able to read, understand, and provide written, dated informed consent prior to Screening Visit. Is male or female, between 18 and 80 years of age at Screening Visit. Is diagnosed with idiopathic PD that meets UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria and requires treatment with and shows responsiveness to levodopa. Has experienced dyskinesia over a period of at least 3 months prior to Screening Visit Has stable peak-effect dyskinesia Has more than one hour of "ON" time with troublesome dyskinesia during daily waking hours on a 24-hour PD subject diary Is on a stable levodopa dosing regimen requiring at least 3 dose administrations but no more than 6 dose administrations per day Exclusion Criteria: Has undergone surgery for the treatment of PD Has a current diagnosis of Substance Use (including alcohol) Disorder (Abuse or Dependence, as defined by Diagnostic and Statistical Manual, Fifth Edition [DSM 5]), Has psychiatric diagnosis of acute psychotic disorder or other psychiatric diagnoses Has a significant risk for suicidal behaviour in the opinion of the investigator during the course of their participation in the study Has current seizure disorders (other than febrile seizures in childhood) requiring treatment with anticonvulsants. Has known serious ongoing symptomatic cerebral disease or cerebrovascular disease or any acute brain trauma requiring treatment with anti-convulsant therapy within 5 years prior Visit 2, Week 0 (Baseline Visit). Has a history of exclusively diphasic, OFF state, myoclonic, dystonic, or akathetic dyskinesia without peak-dose dyskinesia. Other criteria related to other medical conditions to be referred to the protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Contera Clinical Development
Phone
82-2-828-8114
Email
cp.e103@conterapharma.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Contera Clinical Development
Organizational Affiliation
Contera Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Contera Investigational site_FR
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contera
Facility Name
Contera Investigational site_DE
City
Rostock
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contera
Facility Name
Contera Investigational site_IT
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contera
Facility Name
Contera Investigational site_ES
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contera

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31356217
Citation
McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA. J Parkinsons Dis. 2019;9(3):449-465. doi: 10.3233/JPD-199002. No abstract available.
Results Reference
derived

Learn more about this trial

A Study in Parkinson's Disease in Patients With Moderate to Severe Dyskinesia

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