Back to resultsA Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor Fluctuations
Primary Purpose
Parkinson's Disease
Status
Withdrawn
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
ND0612
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
Key Inclusion Criteria:
- Male and female PD subjects of any race aged 30-80 years
- PD diagnosis consistent with the UK Brain Bank Criteria.
- Modified Hoehn & Yahr scale in "ON" state ≤3
- Subjects must experience motor fluctuations and experience an average of at least 2 hours daily in the "OFF" state
- 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.
- Subjects must be on stable doses of all their anti-PD medications for at least 28 days before Baseline (Day 1).
- 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.
- Mini Mental State Examination (MMSE) score >26.
- 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.
Key Exclusion Criteria:
- Atypical or secondary parkinsonism.
- Psychosis or hallucinations in past 6 months.
- 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.
- Clinically significant ECG abnormalities.
- 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.
- Positive serum serology for Hepatitits B Virus (HBV), Hepatitits C Virus (HCV) or Human Immunodeficiency Virus (HIV) at the Screening visit
- 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
- Use of prohibited medications as per protocol
- 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.
Sites / Locations
- Haddasah Ein Kerem Medical center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
ND0612 High dose (Levodopa/Carbidopa solution)
ND0612 Low dose (Levodopa/Carbidopa solution)
Placebo
Arm Description
High dose ND0612 SC infusion over 24 h
Low dose ND0612 SC infusion over 24 h
Placebo SC infusion over 24 h
Outcomes
Primary Outcome Measures
The change from Baseline to Week 16 in the mean percentage of "OFF" time during waking hours, based on patient's home diary assessments
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02782481
Brief Title
A Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor Fluctuations
Official Title
A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Group Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor Fluctuations
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Decision to change the study design
Study Start Date
August 2016 (Actual)
Primary Completion Date
October 15, 2018 (Actual)
Study Completion Date
October 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeuroDerm Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a multicenter, randomized, double blind, placebo controlled parallel group clinical study. Following a screening period of up to 28 days, eligible subjects will be randomized to receive adjunct treatment to oral LD/DDI (Dopa Decarboxylase Inhibitor) with continuous subcutaneous infusion of ND0612 or matching placebo for 16 weeks.
Detailed Description
This phase III randomized, double-blind, placebo controlled, parallel group clinical study will be conducted in 150 subjects with idiopathic PD who are experiencing motor complications despite optimized anti-PD therapy.
The study will investigate the efficacy, safety and tolerability of continuous SC infusion (16 weeks) of ND0612 compared with placebo infusion. The treatment period will be comprised of a 4-week adjustment period during which time the ND0612 infusion dose will remain constant and the oral LD/DDI dose can be decreased or increased back up to the Baseline levels. All other anti-PD treatments must remain constant. During the maintenance period (Weeks 5 to 16) all anti-PD medication including the ND0612/placebo should remain constant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ND0612 High dose (Levodopa/Carbidopa solution)
Arm Type
Experimental
Arm Description
High dose ND0612 SC infusion over 24 h
Arm Title
ND0612 Low dose (Levodopa/Carbidopa solution)
Arm Type
Experimental
Arm Description
Low dose ND0612 SC infusion over 24 h
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo SC infusion over 24 h
Intervention Type
Drug
Intervention Name(s)
ND0612
Other Intervention Name(s)
Levodopa/Carbidopa solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo solution
Primary Outcome Measure Information:
Title
The change from Baseline to Week 16 in the mean percentage of "OFF" time during waking hours, based on patient's home diary assessments
Time Frame
baseline to week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Male and female PD subjects of any race aged 30-80 years
PD diagnosis consistent with the UK Brain Bank Criteria.
Modified Hoehn & Yahr scale in "ON" state ≤3
Subjects must experience motor fluctuations and experience an average of at least 2 hours daily in the "OFF" state
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.
Subjects must be on stable doses of all their anti-PD medications for at least 28 days before Baseline (Day 1).
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.
Mini Mental State Examination (MMSE) score >26.
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.
Key Exclusion Criteria:
Atypical or secondary parkinsonism.
Psychosis or hallucinations in past 6 months.
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.
Clinically significant ECG abnormalities.
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.
Positive serum serology for Hepatitits B Virus (HBV), Hepatitits C Virus (HCV) or Human Immunodeficiency Virus (HIV) at the Screening visit
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
Use of prohibited medications as per protocol
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.
Facility Information:
Facility Name
Haddasah Ein Kerem Medical center
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor Fluctuations
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