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Open-Label Extension Study of ASTORIA

Primary Purpose

Dyskinesias

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
JM-010
Sponsored by
Contera Pharma A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyskinesias

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Is able to read, understand, and provide written, dated informed consent.
  2. Subjects will be deemed likely to comply with study protocol and communicate with study personnel about adverse events (AEs) and other clinically important information.
  3. Completed study visits per protocol in a previous JM-010CS03 study.
  4. Ambulatory or ambulatory-aided (e.g. walker or cane) ability while ON, such that the subject can complete study assessments;
  5. Knowledgeable and reliable caregiver/study partner, if appropriate, to accompany the subject to perform study visits and assist in completion of study instruments, as needed and allowed;
  6. The subject himself/herself wishes to continue taking JM-010, and the investigator deems continued administration to be necessary or appropriate.

Exclusion Criteria:

  1. Discontinued study drug in a previous JM-010 Dyskinesia efficacy study due to intolerable or unacceptable AEs considered to be related to JM-010.
  2. Has other psychiatric (not including hallucinations due to side effects of dopamine therapy), neurological or behavioral disorders that in the opinion of the investigator may interfere with the conduct or interpretation of the study, including dementia, or subject who is considered violent.

  3. Has a significant risk for suicidal behavior in the opinion of the investigator during the course of their participation in the study or

    • At Screening Visit: the subject scores "yes" on items 4 or 5 in the Suicidal Ideation section of the C-SSRS with reference to a 6-month period prior to Screening Visit; or
    • At Screening Visit: the subject has had 1 or more suicidal attempts with reference to a 2 year period prior to Screening Visit; or
    • At Baseline Visit: the subject scores "yes" on items 4 or 5 in the Suicidal Ideation section of the C SSRS with reference to Screening Visit
  4. Has current seizure disorders (other than febrile seizures in childhood) requiring treatment with anti convulsants.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    High dose

    Low dose

    Arm Description

    JM-010 fixed combination drug (Group A) will be administered orally.

    JM-010 fixed combination drug (Group B) will be administered orally.

    Outcomes

    Primary Outcome Measures

    Incidence of clinically significant ECG abnormalities (Safety and Tolerability)
    12-lead electrocardiogram (ECG) assessments: Q-Tc interval in msec
    Incidence of clinically significant cardiovascular abnormalities (Safety and Tolerability)
    Blood pressure in mmHg
    Incidence of suicidal ideation or suicidal behavior (Safety and Tolerability)
    Columbia Suicide Severity Rating Scale (C-SSRS): Score ranges is 0- 50, where a higher score means more severe suicial ideation or behavior

    Secondary Outcome Measures

    Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
    To summarize the efficacy of JM-010 in change in clinical progression of PD from Baseline to Week 48 as measured by the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS UPDRS) Parts I, Ⅱ, and Ⅲ. To summarize the efficacy of JM-010 in change in dyskinesia from Baseline to Week 48 as measured by the MDS-UPDRS Part IV. The score range is 0-132, where a higher score means more severe motor impairment.

    Full Information

    First Posted
    August 8, 2022
    Last Updated
    August 25, 2022
    Sponsor
    Contera Pharma A/S
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05516875
    Brief Title
    Open-Label Extension Study of ASTORIA
    Official Title
    Open-Label Extension Study of JM-010 in Parkinson's Disease Patients With Dyskinesia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 31, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2024 (Anticipated)
    Study Completion Date
    October 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Contera Pharma A/S

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This current open-label extension (OLE) study (JM-010CS-OL) will explore the safety and tolerability of long-term administration of JM-010 of patients who completed 12-week treatment of Phase 2 (JM-010CS03) 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
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    High dose
    Arm Type
    Experimental
    Arm Description
    JM-010 fixed combination drug (Group A) will be administered orally.
    Arm Title
    Low dose
    Arm Type
    Experimental
    Arm Description
    JM-010 fixed combination drug (Group B) will be administered orally.
    Intervention Type
    Drug
    Intervention Name(s)
    JM-010
    Intervention Description
    JM-010
    Primary Outcome Measure Information:
    Title
    Incidence of clinically significant ECG abnormalities (Safety and Tolerability)
    Description
    12-lead electrocardiogram (ECG) assessments: Q-Tc interval in msec
    Time Frame
    Baseline to Week 48
    Title
    Incidence of clinically significant cardiovascular abnormalities (Safety and Tolerability)
    Description
    Blood pressure in mmHg
    Time Frame
    Baseline to Week 48
    Title
    Incidence of suicidal ideation or suicidal behavior (Safety and Tolerability)
    Description
    Columbia Suicide Severity Rating Scale (C-SSRS): Score ranges is 0- 50, where a higher score means more severe suicial ideation or behavior
    Time Frame
    Baseline to Week 48
    Secondary Outcome Measure Information:
    Title
    Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
    Description
    To summarize the efficacy of JM-010 in change in clinical progression of PD from Baseline to Week 48 as measured by the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS UPDRS) Parts I, Ⅱ, and Ⅲ. To summarize the efficacy of JM-010 in change in dyskinesia from Baseline to Week 48 as measured by the MDS-UPDRS Part IV. The score range is 0-132, where a higher score means more severe motor impairment.
    Time Frame
    Baseline to Week 48

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Is able to read, understand, and provide written, dated informed consent. Subjects will be deemed likely to comply with study protocol and communicate with study personnel about adverse events (AEs) and other clinically important information. Completed study visits per protocol in a previous JM-010CS03 study. Ambulatory or ambulatory-aided (e.g. walker or cane) ability while ON, such that the subject can complete study assessments; Knowledgeable and reliable caregiver/study partner, if appropriate, to accompany the subject to perform study visits and assist in completion of study instruments, as needed and allowed; The subject himself/herself wishes to continue taking JM-010, and the investigator deems continued administration to be necessary or appropriate. Exclusion Criteria: Discontinued study drug in a previous JM-010 Dyskinesia efficacy study due to intolerable or unacceptable AEs considered to be related to JM-010. Has other psychiatric (not including hallucinations due to side effects of dopamine therapy), neurological or behavioral disorders that in the opinion of the investigator may interfere with the conduct or interpretation of the study, including dementia, or subject who is considered violent. Has a significant risk for suicidal behavior in the opinion of the investigator during the course of their participation in the study or At Screening Visit: the subject scores "yes" on items 4 or 5 in the Suicidal Ideation section of the C-SSRS with reference to a 6-month period prior to Screening Visit; or At Screening Visit: the subject has had 1 or more suicidal attempts with reference to a 2 year period prior to Screening Visit; or At Baseline Visit: the subject scores "yes" on items 4 or 5 in the Suicidal Ideation section of the C SSRS with reference to Screening Visit Has current seizure disorders (other than febrile seizures in childhood) requiring treatment with anti convulsants.
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Open-Label Extension Study of ASTORIA

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