A Safety, Tolerability and Levodopa Pharmacokinetics Study of Repeated ND0612 in Parkinson's Disease Patients

NCT01883505 | Completed Phase 2 Results

• 1 other identifier: ND0612/003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

This is a randomized, placebo-controlled, double-blind, 2-period study evaluating the safety and pharmacokinetics (PK) of ND0612 in Parkinson's disease (PD) patients on an optimized oral levodopa (LD) regimen and experiencing ≥2 h/day of OFF time. Safety and tolerability, PK profile, pump usability, and the potential clinical effect of ND0612 will be explored in subjects with PD and motor fluctuations.

Conditions

Parkinson's Disease

Keywords

Motor fluctuations; levodopa pharmacokinetics; levodopa and carbidopa solution; continuous subcutaneous delivery; ambulatory infusion pump

Study Arms (4)

Period 1. ND0612

EXPERIMENTAL

A 24h SC infusion of levodopa/carbidopa 270/63 mg daily in addition to the current standard of care treatment for 14 days

Drug: ND0612

Period 1. Placebo

PLACEBO COMPARATOR

A 24h SC infusion of saline in addition to the current standard of care treatment for 14 days

Drug: Placebo

Period 2. ND0612

EXPERIMENTAL

A 24h SC infusion of levodopa/carbidopa 270/63 mg daily in addition to the current standard of care treatment for 7 days

Drug: ND0612

Period 2. ND0612 + Entacapone

EXPERIMENTAL

A 24h SC infusion of levodopa/carbidopa 270/63 mg daily in addition to the current standard of care treatment + Entacapone 200 mg 3 times/day (every 6 hours during waking hours) for 7 days

Drug: ND0612; Drug: Entacapone

Interventions

Placebo DRUG

Subcutaneous infusion via CRONO ND pump

Also known as: Saline

Period 1. Placebo

ND0612 DRUG

Subcutaneous infusion via CRONO ND pump

Also known as: Levodopa and carbidopa SC solution

Period 1. ND0612; Period 2. ND0612; Period 2. ND0612 + Entacapone

Entacapone DRUG

200 mg oral tablet

Period 2. ND0612 + Entacapone

Eligibility Criteria

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

You may qualify if:

• Men and women with idiopathic PD whose diagnosis was confirmed by presence of at least two of the cardinal signs (resting tremor, bradykinesia, rigidity) and lacking any other known or suspected cause of parkinsonism.
• Patients who experienced motor fluctuations averaging at least two hours daily in the "OFF" state during the waking hours (including morning akinesia), corresponding to the end-of-dose deterioration phenomenon ("wearing off") confirmed by the baseline home diaries.
• Modified Hoehn and Yahr stage \< 5 in the "OFF" state.
• Patients who were taking optimized LD/decarboxylase inhibitor therapy (based on the investigator's judgment) that was stable for at least 14 days prior to baseline. Patients were to receive at least three daily doses of LD (which could include a bedtime dose) with at least three hours between doses.
• Patients treated with dopaminergic agonists and other anti-PD drugs were to be on stable doses for at least 30 days prior to baseline and those doses were to remain constant throughout the study period.
• Women who were postmenopausal, surgically sterilized, or using adequate birth control. Women of childbearing potential were to have a negative pregnancy test (beta human chorionic gonadotropin \[hCG\] serum) at screening.
• Patients between the ages of 30 and 80.
• Patients willing and able to give informed consent.
• Patients and/or caregivers able to understand and follow instructions for use of SC delivery pump.
• Patients who demonstrated the ability to keep accurate diaries of PD symptoms (ON-OFF diaries).

You may not qualify if:

• Patients treated with controlled release formulation of LD/CD. (Note: Patients treated with Entacapone, Tolcapone, or Stalevo were allowed to participate in Period 1 but were excluded from Period 2 participation)
• Patients with a clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation. Such conditions may include gastrointestinal, cardiovascular, pulmonary, hepatic, renal, or metabolic diseases or malignancies as determined by medical history, physical exam, laboratory tests, or ECG.
• History of melanoma or significant skin disorders.
• Patients with significant cognitive impairment as defined by a MMSE score of \< 25.
• Patients treated with dopaminergic agonists, anticholinergics, monoamine oxidase (MAO)-B inhibitors, or antipsychotics that need dose adjustment in the 30 days prior to Study Baseline.
• Patients with clinically significant psychiatric illness, including major depression (according to Diagnostic and Statistical Manual of Mental Disorders \[DSM\] IV criteria for major depressive episode) or other problems that might compromise their ability to provide consent or participate fully in the study.
• Patients with a history of alcohol or substance abuse within the past two years.
• Patients who have taken experimental medications within 60 days prior to baseline.
• Patients who have undergone a neurosurgical intervention for PD (e.g. pallidotomy, thalamotomy, transplantation, or deep brain stimulation procedures).
• Patients with severe disabling dyskinesias.
• Patients with hearing, visual or motor impairments that prevent them from using the pump or reacting effectively to errors.

Sponsors & Collaborators

• NeuroDerm Ltd.: lead

Study Sites (3)

Hadassah Medical Center

Jerusalem, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Tel Aviv Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Levodopa; Sodium Chloride; entacapone

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; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Senior Medical Director

  NeuroDerm Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2 arms in Period 1 (14 days, randomized double-blind) followed by 2 arms in Period 2 (7 days, randomized open-label)

Study Record Dates

• First Submitted: June 9, 2013
• First Posted: June 21, 2013
• Study Start: January 6, 2014
• Primary Completion: April 26, 2015
• Study Completion: April 26, 2015
• Last Updated: July 9, 2026
• Results First Posted: July 9, 2026

Record last verified: 2026-07

Locations

IL (3)