Open-Label Extension Study of ASTORIA

Contera Pharma

Status and phase: Terminated; Phase 2

Conditions: Dyskinesias

Treatments: Drug: JM-010

Study type: Interventional

Funder types: Industry

Identifiers

NCT05516875

JM-010CS-OL

2022-002818-16 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

High dose

Experimental group

Description:

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

Treatment:

Drug: JM-010

Low dose

Experimental group

Description:

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

Treatment:

Drug: JM-010