Open-Label Extension Study of ASTORIA

NCT05516875 | Terminated Phase 2

• 2 other identifiers: JM-010CS-OL2022-002818-16
• Study Type: interventional
• Target: 6
• Locations: 2 countries
• Sites: 2

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.

Conditions

Dyskinesias

Outcome Measures

Primary Outcomes (3)

• Incidence of clinically significant ECG abnormalities (Safety and Tolerability)

  12-lead electrocardiogram (ECG) assessments: Q-Tc interval in msec

  Baseline to Week 48

• Incidence of clinically significant cardiovascular abnormalities (Safety and Tolerability)

  Blood pressure in mmHg

  Baseline to Week 48

• 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

  Baseline to Week 48

Secondary Outcomes (1)

• Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  Baseline to Week 48

Study Arms (2)

High dose

EXPERIMENTAL

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

Drug: JM-010

Low dose

EXPERIMENTAL

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

Drug: JM-010

Interventions

JM-010 DRUG

JM-010

High dose; Low dose

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Contera Pharma A/S: lead

Study Sites (2)

Contera Investigational site_IT

Roma, Italy

Location

Contera Investigational site_ES

Madrid, Spain

Location

MeSH Terms

Conditions

Dyskinesias

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Contera Clinical Development

  Contera Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 26, 2022
• Study Start: January 19, 2024
• Primary Completion: May 22, 2024
• Study Completion: June 27, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); IT (1)