Open-Label Extension Study of ASTORIA

Dyskinesias Clinical Trial

Official title:

Open-Label Extension Study of JM-010 in Parkinson's Disease Patients With Dyskinesia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05516875
• Other study ID #: JM-010CS-OL
• Secondary ID: 2022-002818-16
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 31, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: August 2022
• Source: Contera Pharma A/S
• Contact: Contera Clinical Development
• Phone: 82-2-828-8114
• Email: cp.e103[@]conterapharma.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: October 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyskinesias

Intervention

Drug:
• JM-010
JM-010

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Contera Pharma A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of clinically significant ECG abnormalities (Safety and Tolerability)	12-lead electrocardiogram (ECG) assessments: Q-Tc interval in msec	Baseline to Week 48
Primary	Incidence of clinically significant cardiovascular abnormalities (Safety and Tolerability)	Blood pressure in mmHg	Baseline to Week 48
Primary	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	Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	To summarize the efficacy of JM-010 in change in clinical progression of PD from Baseline to Week 48 as measured by the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS UPDRS) Parts I, ?, and ?.; To summarize the efficacy of JM-010 in change in dyskinesia from Baseline to Week 48 as measured by the MDS-UPDRS Part IV.; The score range is 0-132, where a higher score means more severe motor impairment.	Baseline to Week 48