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NCT Number: NCT02096601

A Safety, Tolerability, and Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients

An open-label randomized study to evaluate the Safety, Tolerability, and PK of Low and High single doses of ND0612 (i.e. LD/CD ratio 60/7.5 mg/mL and 60/14 mg/mL), as well as the combination with oral Entacapone (concomitant catechol-O-methyl transferase [COMT] inhibitor) in PD subjects with well-defined morning "OFF" and a good response to LD. Exploratory efficacy parameters were collected (early evidence of effectiveness as part of Phase 1).

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hadassah Medical Center, Jerusalem, Israel

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About this study

PD subjects were randomized in Low or High LD dose study group in 1:1 ratio. Each patient received singe doses ND0612 over 3 days: Day 1. LD/CD 60/7.5 mg/mL, Day 2. LD/CD 60/14 mg, and Day 3. LD/CD 60/14 mg/mL with Entacapone.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female PD patients of any race aged 30 to 80 years
  • PD diagnosis consistent with the UK PD Society Brain Bank criteria.
  • Stable doses of anti PD drugs for at least 30 days
  • PD patients with well-defined morning "OFF" and a good response to LD
  • MMSE score > 26
  • No clinically significant medical, psychiatric or laboratory abnormalities

Exclusion criteria

  • Atypical or secondary Parkinsonism.
  • Acute psychosis or hallucinations.
  • Subjects treated with neuroleptics
  • History of melanoma or significant skin disorders.
  • Prior neurosurgical procedure for PD.
  • Patients with a history of drug abuse or alcoholism
  • Clinically significant ECG abnormalities.
  • Renal or liver dysfunction
  • Subjects who have participated in another clinical study within 30 days

Treatment and study plan

LD/CD SC solution

Drug

Levodopa/carbidopa SC solution

Other names: ND0612

Entacapone

Drug

Entacapone 200 mg oral tablet

Primary outcomes

  1. Adverse events frequency

    Time frame: Up to 6 weeks

  2. LD, CD and 3-OMD PK analysis from sample taken on Days 3, 4 and 5 will be used to determine the Fluctuation Index, its CV, AUC, Cmin, Cmax, and tmax.

    Time frame: Days 1, 2, 3 and 4

  3. Tolerability: Number of patients who discontinued due to adverse events

    Time frame: Up to 6 weeks

Sponsors and collaborators

Lead sponsor

NeuroDerm Ltd.

Industry

Collaborators

  • Michael J. Fox Foundation for Parkinson's Research

Registry information

Official study title

A Multicenter, Open-Label, Randomized, Dose-Finding Study Testing the Safety, Tolerability, and Pharmacokinetics (PK) of ND0612, a Liquid Formulation of Levodopa/Carbidopa (LD/CD) Delivered as a Continuous Subcutaneous Infusion (SC) in Parkinson's Disease (PD) Patients Treated With LD

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 26, 2014
Registry last updated
Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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