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

January 17, 2024 updated by: NeuroDerm Ltd.

A Phase I/II Pharmacokinetic (PK) Study of ND0612, a Liquid Formulation of Levodopa/Carbidopa (LD/CD), Delivered as a Continuous Subcutaneous in Parkinson's Disease (PD) Patients Treated With LD

An open label phase I/IIa study to evaluate the safety and tolerability of 6 different doses/ infusion rates of subcutaneous (SC) ND0612 solution in PD patients; to determine if continuous delivery of levodopa and carbidopa can provide reduced variability in plasma concentration; to test and compare the PK profile of high and low concentrations of CD; to assess preliminary efficacy.

Study Overview

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Jerusalem, Israel
        • Hadassah Medical Center
      • Tel Aviv, Israel
        • Tel Aviv Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ND0612
Levodopa and carbidopa SC solution
Levodopa and carbidopa SC solution
Other Names:
  • ND0612
Active Comparator: Oral levodopa and carbidopa
Oral levodopa and carbidopa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events frequency
Time Frame: Up to 6 weeks
Up to 6 weeks
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
Days 1, 2, 3 and 4
Tolerability: Number of patients who discontinued due to adverse events
Time Frame: Up to 6 weeks
Up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2014

Primary Completion (Actual)

March 15, 2015

Study Completion (Actual)

March 15, 2015

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

March 23, 2014

First Posted (Estimated)

March 26, 2014

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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