Clinical trial NCT05516875: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Dyskinesias
Lead sponsor: Contera Pharma A/S
Sponsor class: INDUSTRY
First posted: 2022-08-26
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Incidence of clinically significant ECG abnormalities (Safety and Tolerability)
timeFrame: Baseline to Week 48
measure: Incidence of clinically significant cardiovascular abnormalities (Safety and Tolerability)
timeFrame: Baseline to Week 48
measure: Incidence of suicidal ideation or suicidal behavior (Safety and Tolerability)
timeFrame: Baseline to Week 48
Secondary outcomes:
measure: Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: Baseline to Week 48
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Contera Investigational site_IT
city: Madrid
country: Spain
facility: Contera Investigational site_ES
Study officials:
affiliation: Contera Pharma
name: Contera Clinical Development
role: STUDY_DIRECTOR
References: