Open-Label Extension Study of ASTORIA

• Status: Not yet recruiting
• Trial end date: 2024-10-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Contera Pharma A/S

Criteria

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.