Subjects with Parkinson’s Disease with motor fluctuations MedDRA version: 19.1 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: levodopa/carbidopa solution
Product Code: ND0612
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Levodopa
Sponsors
NeuroDerm Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female PD subjects of any race aged 30-80 years 2. PD diagnosis consistent with the UK Brain Bank Criteria. 3. Modified Hoehn & Yahr scale in “ON” state =3 4. Subjects must experience motor fluctuations and experience an average of at least 2 hours daily in the “OFF” state 5. Taking at least 4 doses/day of IR LD/DDI (or at least 3 doses/day of Rytary) and taking, or having taken therapeutic doses of at least 2 other classes of anti-PD medications. 6. Subjects must be on stable doses of all their anti-PD medications for at least 28 days before Baseline (Day 1). 7. Subject and/or study partner must demonstrate ability to keep accurate diary entries of PD symptoms (“ON-OFF” diaries) with at least 75% concordance with the study rater by the end of the diary training session at the end of the screening period. 8. Mini Mental State Examination (MMSE) score >26. 9. Female subjects must be surgically sterile (hysterectomy, bilateral oophorectomy, or tubal ligation), postmenopausal (defined as cessation of menses for at least 1 year), or willing to practice a highly effective method of contraception. 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 120
Exclusion criteria
Exclusion criteria: 1. Atypical or secondary parkinsonism. 2. Psychosis or hallucinations in past 6 months. 3. Subjects with a clinically significant or unstable medical, surgical, psychiatric condition or laboratory abnormalities which, in the opinion of the Investigator or the EAC, represents a safety risk, makes the subject unsuitable for study entry or potentially unable to complete all aspects of the study. 4. Clinically significant ECG abnormalities. 5. Renal or liver dysfunction that may alter drug metabolism including Screening visit serum levels of creatinine >1.3 mg/dL, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2x upper limit of normal (ULN), total bilirubin >2.5 mg/dL. 6. Positive serum serology for Hepatitits B Virus (HBV), Hepatitits C Virus (HCV) or Human Immunodeficiency Virus (HIV) at the Screening visit 7. Any malignancy in the 5 years prior to randomization excluding basal cell carcinoma of the skin or cervical carcinoma in situ that have been successfully treated 8. Use of prohibited medications as per protocol 9. Subjects who have previously undergone treatment for PD with a neurosurgical intervention (e.g., pallidotomy, thalamotomy, transplantation, deep brain stimulation procedures), Duodopa/Duopa, or continuous dopaminergic or apomorphine infusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint is the change from Baseline to Week 16 in the mean percentage of “OFF” time during waking hours, based on patient's home diary assessments on 3 consecutive days before the visit. The “OFF” time will also be presented as hours normalized to 16 waking hours. ;Main Objective: To determine the effect of ND0612 on daily “OFF” time using a subject completed home diary.; Secondary Objective: To determine the effect of ND0612 on daily “ON” time without troublesome dyskinesia (defined as the sum of "ON" time without dyskinesia and “ON” time with non-troublesome dyskinesia) using a subject completed home diary. ;Timepoint(s) of evaluation of this end point: Week 16 visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Week 16 visit; Secondary end point(s): The key secondary efficacy endpoint is the change from Baseline to Week 16 in the mean percentage of “ON” time without troublesome dyskinesia during waking hours, based on patient's home diary assessments on the 3 consecutive days before the visit. "ON" time without troublesome dyskinesia is defined as the sum of "ON" time without dyskinesia and “ON” time with non-troublesome dyskinesia. | — |
Countries
Belgium, Canada, Denmark, France, Hungary, Israel, Netherlands, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactEdith Dekel
NeuroDerm Ltd.
Outcome results
None listed