DyskinesiasPhase 2NCT05516875
Open-Label Extension Study of ASTORIA
A Phase 2 study testing JM-010 in people with Dyskinesias, run by Contera Pharma A/S at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dyskinesias
- What is being tested?
- JM-010
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 19 Jan 2024to 27 Jun 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 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.
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
- Conditions
- Dyskinesias
- Being tested
- JM-010
- Medical subject headings
- Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JM-010Drug
JM-010
| Study group | Role | What they receive |
|---|---|---|
| High dose | Experimental | JM-010 fixed combination drug (Group A) will be administered orally. Receives: Drug: JM-010 |
| Low dose | Experimental | JM-010 fixed combination drug (Group B) will be administered orally. Receives: Drug: JM-010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinically significant ECG abnormalities (Safety and Tolerability)
12-lead electrocardiogram (ECG) assessments: Q-Tc interval in msec
Measured: Baseline to Week 48
Incidence of clinically significant cardiovascular abnormalities (Safety and Tolerability)
Blood pressure in mmHg
Measured: Baseline to Week 48
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
Measured: Baseline to Week 48
Secondary outcomes (1)
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, Ⅱ, and Ⅲ.
- 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.
Measured: Baseline to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start19 Jan 2024
- Primary completion22 May 2024
- Study completion27 Jun 2024
Why it stopped: The trial is terminated based on business decision, not due to safety concerns or regulatory requirements.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyskinesiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Contera Pharma A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Contera Clinical Development, Study director, Contera Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516875
- Sponsor's protocol ID
- JM-010CS-OL
- Other IDs
- 2022-002818-16
- Status last verified
- Oct 2024
- First submitted
- 8 Aug 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Extension Study of JM-010 in Parkinson's Disease Patients With Dyskinesia
- ClinicalTrials.gov ID
- NCT05516875
- Acronym / sponsor ID
- JM-010CS-OL
- Conditions
- Dyskinesias
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial is terminated based on business decision, not due to safety concerns or regulatory requirements.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Contera Pharma A/SIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose | Experimental | Drug: JM-010JM-010 fixed combination drug (Group A) will be administered orally. |
| Low dose | Experimental | Drug: JM-010JM-010 fixed combination drug (Group B) will be administered orally. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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 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.
- Has a significant risk for suicidal behavior in the opinion of the investigator during the course of their participation in the study or
- Has current seizure disorders (other than febrile seizures in childhood) requiring treatment with anti convulsants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JM-010JM-010 | Drug | High dose, Low dose |
Primary outcome
Incidence of clinically significant ECG abnormalities (Safety and Tolerability)
Time frame: Baseline to Week 48
12-lead electrocardiogram (ECG) assessments: Q-Tc interval in msec
Incidence of clinically significant cardiovascular abnormalities (Safety and Tolerability)
Time frame: Baseline to Week 48
Blood pressure in mmHg
Incidence of suicidal ideation or suicidal behavior (Safety and Tolerability)
Time frame: Baseline to Week 48
Columbia Suicide Severity Rating Scale (C-SSRS): Score ranges is 0- 50, where a higher score means more severe suicial ideation or behavior
1 secondary outcome
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: Baseline to Week 48
Results and safety
The study was stopped early (reason given: The trial is terminated based on business decision, not due to safety concerns or regulatory requirements.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Contera Clinical Development study director
Contera Pharma
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JM-010 in people with Dyskinesias, run by Contera Pharma A/S at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The trial is terminated based on business decision, not due to safety concerns or regulatory requirements.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of clinically significant ECG abnormalities (Safety and Tolerability) (time frame: Baseline to Week 48). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.