DyskinesiasPhase 2ASTORIANCT03956979
A Study in Parkinson's Disease in Patients With Moderate to Severe Dyskinesia
A Phase 2 study testing JM-010 group A and JM-010 group B in people with Dyskinesias, run by Contera Pharma at 5 sites in 5 countries.
Trial summary
The current study will explore the efficacy, safety and tolerability of 2 dose combinations of JM-010 to determine the optimal doses of each component to be studied in confirmatory clinical trials. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Dyskinesias
- What is being tested?
- JM-010 group A and JM-010 group B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 22 Jul 2019to 21 Mar 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is able to read, understand, and provide written, dated informed consent prior to Screening Visit.
- Is male or female, between 18 and 80 years of age at Screening Visit.
- Is diagnosed with idiopathic PD that meets UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria and requires treatment with and shows responsiveness to levodopa.
- Has experienced dyskinesia over a period of at least 3 months prior to Screening Visit
- Has stable peak-effect dyskinesia
- Has more than one hour of "ON" time with troublesome dyskinesia during daily waking hours on a 24-hour PD subject diary
- Is on a stable levodopa dosing regimen requiring at least 3 dose administrations but no more than 6 dose administrations per day
Who cannot join
- Has undergone surgery for the treatment of PD
- Has a current diagnosis of Substance Use (including alcohol) Disorder (Abuse or Dependence, as defined by Diagnostic and Statistical Manual, Fifth Edition [DSM 5]),
- Has psychiatric diagnosis of acute psychotic disorder or other psychiatric diagnoses
- Has a significant risk for suicidal behaviour in the opinion of the investigator during the course of their participation in the study
- Has current seizure disorders (other than febrile seizures in childhood) requiring treatment with anticonvulsants.
- Has known serious ongoing symptomatic cerebral disease or cerebrovascular disease or any acute brain trauma requiring treatment with anti-convulsant therapy within 5 years prior Visit 2, Week 0 (Baseline Visit).
- Has a history of exclusively diphasic, OFF state, myoclonic, dystonic, or akathetic dyskinesia without peak-dose dyskinesia.
- Other criteria related to other medical conditions to be referred to the protocol.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study in Parkinson's Disease Patients With Moderate to Severe Dyskinesia to Assess the Efficacy and Safety/Tolerability of Two Dose Combinations of JM-010
The current study will explore the efficacy, safety and tolerability of 2 dose combinations of JM-010 to determine the optimal doses of each component to be studied in confirmatory clinical trials.
Read the detailed description
This is a Phase 2, double-blind, double-dummy, placebo-controlled, randomized, parallel group, multicentre study.
Subjects with a diagnosis of moderate to severe dyskinesia in Parkinson's disease (PD) will complete a Screening Visit to assess eligibility to participate in the study.
Subjects will continue with their usual levodopa treatment regimen for the duration of study participation.
The screening assessment period will be a minimum of 1 week up to a maximum of 6 weeks. Subjects deemed to be eligible at the end of the Screening Visit will be randomly assigned in a 1:1:1 ratio to receive either 1 of the 2 dose combinations of JM-010 and 1 placebo, or 2 placebos as per the double-dummy study design. The randomized subjects will be followed treatment periods for 12 weeks and safety follow periods for 2 weeks, including pharmacokinetic (PK) sub-study.
- Conditions
- Dyskinesias
- Being tested
- JM-010 group A, JM-010 group B, Placebos
- Medical subject headings
- Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JM-010 group ADrug
Also called JM-010
JM-010 fixed combination drug (Group A) + Placebo 2
JM-010 group BDrug
Also called JM-010
JM-010 fixed combination drug (Group B) + Placebo 1
PlacebosDrug
Also called Placebo
Placebo 1 + Placebo 2
| Study group | Role | What they receive |
|---|---|---|
| JM-010 group A | Experimental | Group A (JM-010 dose fixed combination drug(tablet)) +Placebo 2 Receives: Drug: JM-010 group A |
| JM-010 group B | Experimental | Group B (JM-010 8/0.8mg dose fixed combination drug(tablet)) + Placebo 1 Receives: Drug: JM-010 group B |
| Placebo | Placebo comparator | Double-dummy - 2 tablets = Placebo 1 +Placebo 2 Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Dyskinesia Rating Scale (UDysRS)
To compare the efficacy of JM-010 to that of placebo therapy in reducing dyskinesia severity in Parkinson's Disease by evaluating the total score mean change from Baseline to Week 12 in the sum of the items comprising UDysRS. The scoring range is 0-104, and a higher score indicates more severe dyskinesia.
Measured: 12 Weeks
Secondary outcomes (4)
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
To compare the efficacy of JM-010 to that of placebo therapy as measured by the sum of the MDS-UPDRS Part III score changes from Baseline to Weeks 2, 4, 8, 12. The score range is 0-132, where a higher score means more severe motor impairment.
Measured: 2 Weeks, 4 Weeks, 8 Weeks, 12 Weeks
Clinician's Global Impression-Change (CGI-C) score
To compare the efficacy of JM-010 to that of placebo therapy in relation to improvement in clinician-reported PD symptoms as measured by CGI-C score at Week 12. The CGI-C uses the following ratings: 0=not assessed; 1=very much improved; 2=much improved; 3=a little improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse.
Measured: 12 Weeks
Hauser diary
To compare the efficacy of JM-010 to that of placebo therapy as measured by ON time without troublesome dyskinesia changes, OFF time changes, ON time with troublesome dyskinesia changes, Total time with dyskinesia changes from Baseline to Week 2, 4, 8, 12 in Hauser diary
Measured: 2 Weeks, 4 Weeks, 8 Weeks, 12 Weeks
Unified Dyskinesia Rating Scale (UDysRS)
To compare the efficacy of JM-010 to that of placebo therapy in reducing dyskinesia severity in Parkinson's Disease by evaluating the total score mean change from Baseline to Week 2, 4, 8.
The scoring range is 0-104, and a higher score indicates more severe dyskinesia.
Measured: 2 Weeks, 4 Weeks, 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start22 Jul 2019
- Primary completion7 Mar 2024
- Study completion21 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Contera Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bukwang Pharmaceutical
- Responsible party
- Sponsor
- Investigators
- Contera Clinical Development, Study director, Contera Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956979
- Sponsor's protocol ID
- JM-010CS03
- Other IDs
- 2017-003415-19, 2017
- Acronym
- ASTORIA
- Status last verified
- Jun 2024
- First submitted
- 17 May 2019
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA. J Parkinsons Dis. 2019;9(3):449-465. doi: 10.3233/JPD-199002. No abstract available.
PubMed 31356217
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study in Parkinson's Disease Patients With Moderate to Severe Dyskinesia to Assess the Efficacy and Safety/Tolerability of Two Dose Combinations of JM-010
- ClinicalTrials.gov ID
- NCT03956979
- Acronym / sponsor ID
- ASTORIA / JM-010CS03
- Conditions
- Dyskinesias
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Contera PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Bukwang Pharmaceutical
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 7 Mar 2024 (actual)
- Study completion
- 21 Mar 2024 (actual)
- First posted
- 21 May 2019 (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.
The current study will explore the efficacy, safety and tolerability of 2 dose combinations of JM-010 to determine the optimal doses of each component to be studied in confirmatory clinical trials.
Detailed description
This is a Phase 2, double-blind, double-dummy, placebo-controlled, randomized, parallel group, multicentre study.
Subjects with a diagnosis of moderate to severe dyskinesia in Parkinson's disease (PD) will complete a Screening Visit to assess eligibility to participate in the study.
Subjects will continue with their usual levodopa treatment regimen for the duration of study participation.
The screening assessment period will be a minimum of 1 week up to a maximum of 6 weeks. Subjects deemed to be eligible at the end of the Screening Visit will be randomly assigned in a 1:1:1 ratio to receive either 1 of the 2 dose combinations of JM-010 and 1 placebo, or 2 placebos as per the double-dummy study design. The randomized subjects will be followed treatment periods for 12 weeks and safety follow periods for 2 weeks, including pharmacokinetic (PK) sub-study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| JM-010 group A | Experimental | Drug: JM-010 group AGroup A (JM-010 dose fixed combination drug(tablet)) +Placebo 2 |
| JM-010 group B | Experimental | Drug: JM-010 group BGroup B (JM-010 8/0.8mg dose fixed combination drug(tablet)) + Placebo 1 |
| Placebo | Placebo comparator | Drug: PlacebosDouble-dummy - 2 tablets = Placebo 1 +Placebo 2 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Is able to read, understand, and provide written, dated informed consent prior to Screening Visit.
- Is male or female, between 18 and 80 years of age at Screening Visit.
- Is diagnosed with idiopathic PD that meets UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria and requires treatment with and shows responsiveness to levodopa.
- Has experienced dyskinesia over a period of at least 3 months prior to Screening Visit
- Has stable peak-effect dyskinesia
Key exclusion criteria (8 listed)
- Has undergone surgery for the treatment of PD
- Has a current diagnosis of Substance Use (including alcohol) Disorder (Abuse or Dependence, as defined by Diagnostic and Statistical Manual, Fifth Edition [DSM 5]),
- Has psychiatric diagnosis of acute psychotic disorder or other psychiatric diagnoses
- Has a significant risk for suicidal behaviour in the opinion of the investigator during the course of their participation in the study
- Has current seizure disorders (other than febrile seizures in childhood) requiring treatment with anticonvulsants.
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-010 group AAlso: JM-010JM-010 fixed combination drug (Group A) + Placebo 2 | Drug | JM-010 group A |
| JM-010 group BAlso: JM-010JM-010 fixed combination drug (Group B) + Placebo 1 | Drug | JM-010 group B |
| PlacebosAlso: PlaceboPlacebo 1 + Placebo 2 | Drug | Placebo |
Primary outcome
Unified Dyskinesia Rating Scale (UDysRS)
Time frame: 12 Weeks
To compare the efficacy of JM-010 to that of placebo therapy in reducing dyskinesia severity in Parkinson's Disease by evaluating the total score mean change from Baseline to Week 12 in the sum of the items comprising UDysRS. The scoring range is 0-104, and a higher score indicates more severe dyskinesia.
4 secondary outcomes
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: 2 Weeks, 4 Weeks, 8 Weeks, 12 Weeks
Clinician's Global Impression-Change (CGI-C) score
Time frame: 12 Weeks
Hauser diary
Time frame: 2 Weeks, 4 Weeks, 8 Weeks, 12 Weeks
Unified Dyskinesia Rating Scale (UDysRS)
Time frame: 2 Weeks, 4 Weeks, 8 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Derived from this study: PubMed 31356217McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA. J Parkinsons Dis. 2019;9(3):449-465. doi: 10.3233/JPD-199002. No abstract available.
- 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
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JM-010 group A and JM-010 group B in people with Dyskinesias, run by Contera Pharma at 5 sites in 5 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Germany, Italy, South Korea, 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Unified Dyskinesia Rating Scale (UDysRS) (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03956979, which also lists 1 linked publication.
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 17 Jun 2024.