Open-Label Extension Study of ASTORIA
Reason given: The trial is terminated based on business decision, not due to safety concerns or regulatory requirements.
Key facts
- Phase
- Phase 2
This trial has no sites in United States.
It has sites in 2 countries. Choose a country to see its sites.
Trial details
- Who runs it
- Contera Pharma A/S
- Trial code
- NCT05516875
- Record updated
- 15 October 2024
- Original description
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.Read full original descriptionShow less
Open-Label Extension Study of JM-010 in Parkinson's Disease Patients With Dyskinesia
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.
Inclusion: 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: 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 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; 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.