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

NCT02782481 | Withdrawn Phase 3 DMC

• 1 other identifier: ND0612L-007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• The change from Baseline to Week 16 in the mean percentage of "OFF" time during waking hours, based on patient's home diary assessments

  baseline to week 16

Study Arms (3)

ND0612 High dose (Levodopa/Carbidopa solution)

EXPERIMENTAL

High dose ND0612 SC infusion over 24 h

Drug: ND0612

ND0612 Low dose (Levodopa/Carbidopa solution)

EXPERIMENTAL

Low dose ND0612 SC infusion over 24 h

Drug: ND0612

Placebo

PLACEBO COMPARATOR

Placebo SC infusion over 24 h

Drug: Placebo

Interventions

ND0612 DRUG

Also known as: Levodopa/Carbidopa solution

ND0612 High dose (Levodopa/Carbidopa solution); ND0612 Low dose (Levodopa/Carbidopa solution)

Placebo DRUG

Also known as: Placebo solution

Placebo

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NeuroDerm Ltd.: lead

Study Sites (1)

Haddasah Ein Kerem Medical center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Levodopa

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2016
• First Posted: May 25, 2016
• Study Start: August 1, 2016
• Primary Completion: October 15, 2018
• Study Completion: October 15, 2018
• Last Updated: December 10, 2019

Record last verified: 2019-12

Locations

IL (1)