Parkinson's Disease Patients with Dyskinesia MedDRA version: 21.1 Level: LLT Classification code 10013113 Term: Disease Parkinson's System Organ Class: 100000004852
Conditions
Sponsors
Contera Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Group 1 Below are the eligibility criteria for subjects who are continuing directly into JM-010CS-OL without a time gap between their JM-010CS03 study and JM-010CS-OL study. 1. Is able to read, understand, and provide written, dated informed consent. 2. Is deemed likely to comply with study protocol and communicate with study personnel about AEs and other clinically important information. 3. Has completed study visits per protocol in a previous JM-010CS03 study. 4. Has ambulatory or ambulatory-aided (e.g., walker or cane) ability while ON, such that the subject can complete study assessments. 5. Has a 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. Wishes to continue taking JM-010, and the investigator deems continued administration to be necessary or appropriate. France-specific criteria: 7. Is registered to a social security scheme or is a beneficiary of one Group 2 Below are the eligibility criteria for subjects who participated in a previous JM-010CS03 study and will enter JM-010CS-OL study with a time gap. A subject will be eligible for inclusion only if each of the following criteria are met: 1. Is able to read, understand, and provide written, dated informed consent. 2. Is deemed likely to comply with study protocol and communicate with study personnel about AEs and other clinically important information. 3. Has completed study visits per protocol in a previous JM-010CS03 study. 4. Has ambulatory or ambulatory-aided (e.g., walker or cane) ability while ON, such that the subject can complete study assessments. 5. Has a 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. Wishes to continue taking JM-010, and the investigator deems continued administration to be necessary or appropriate. France-specific criteria: 7. Is registered to a social security scheme or is a beneficiary of on Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Group 1 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. 5. Has current evidence of clinically significant hematological, autoimmune, endocrine, cardiovascular, peripheral vascular, renal, severe liver failure, gastrointestinal disorder, or other known condition that would possibly interfere with the subject’s participation in the study and/or assessments. 6. Has orthostatic or symptomatic hypotension: a decrease of > 20 mm Hg in systolic blood pressure (SBP) and/or > 10 mm Hg in diastolic blood pressure (DBP) after at least 3 minutes standing compared to the previous supine blood pressure (BP) in 2 separate measurements and/or history or current episode of repeated hypotensive or vasovagal syncope. 7. Has known history or current episode of the following: • Stroke or transient ischemic attack. • Ischemic heart disease, coronary vasospasm (Prinzmetal’s angina), peripheral artery disease, or symptoms of ischemic heart disease or signs compatible with ischemic heart disease or New York Heart Association Functional Classification of Heart Failure Class III or IV within 2 years prior to screening. • Uncontrolled hypertension. • Any clinically significant ECG abnormalities, including any findings of abnormal ventricular conduction or rhythm other than isolated premature ventricular contractions or first degree atrioventricular block. 8. Planned participation in another interventional clinical trial. 9. Is a female who is pregnant (confirmed by laboratory testing), nursing, or is planning to become pregnant for the duration of study participation (from the Screening Visit through the completion of the final follow-up visit) or is a woman of childbearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner, and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of postmenopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea and are using 1 or more of the following acceptable methods of contraception. • surgical sterilization • hormonal contraception • double-barrier methods 10. Anticipated need for treatment with restricted medication. France-specific criteria: 11. Is a protected person and/or is a person who is subje
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the safety and tolerability of JM-010 from Baseline to Week 48. Safety and tolerability will be assessed in relation to the following: • Adverse events (AEs) • Clinical laboratory evaluations • 12-lead electrocardiogram (ECG) assessments • Vital signs • Columbia-Suicide Severity Rating Scale (C-SSRS);Secondary Objective: The secondary objectives of this OLE study are as follows: • 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-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. ;Primary end point(s): Safety endpoints include the following: 1. AEs 2. Clinical laboratory evaluations 3. 12-lead ECG assessments 4. Vital signs 5. C-SSRS ;Timepoint(s) of evaluation of this end point: week 0, week 12, week 24, week 36, week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy Endpoint 1. MDS-UPDRS combined scores (Parts I, II, and III) changes from Baseline to Week 24 and 48 2. MDS-UPDRS Part IV score changes from Baseline to Week 24 and 48 3. MDS-UPDRS Part IV (items 4.1 and 4.2 only) score changes from Baseline to Week 48;Timepoint(s) of evaluation of this end point: week 0, week 24, week 48 | — |
Countries
France, Germany, Italy, Korea, Republic of, Spain
Contacts
Public ContactClinical Trials Information
Contera Pharma A/S
Outcome results
None listed