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A Phase I/IIa Study of Safety, Tolerability and Plasma Concentration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients

This study is not yet open for participant recruitment.
Verified November 2012 by NeuroDerm Ltd.
Sponsor:
Information provided by (Responsible Party):
NeuroDerm Ltd.
ClinicalTrials.gov Identifier:
NCT01725802
First received: November 4, 2012
Last updated: November 8, 2012
Last verified: November 2012
History of Changes
  Purpose

In this Phase I/IIa study, the effect of continuous subcutaneous administration of LD/CD solution (ND0612) on the safety and PK profile of LD will be examined.


Condition Intervention Phase
Parkinson's Disease
 Drug: levodopa and carbidopa solution for SC administration
Drug: Placebo
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I/IIa, Single Dose, Single-centre, Randomized, Crossover, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by NeuroDerm Ltd.:

Primary Outcome Measures:
  • Incidence and frequency of adverse events [ Time Frame: up to 8 weeks ] [ Designated as safety issue: Yes ]
    1. Incidence and frequency of adverse events
    2. Adverse events reporting related to the ND0612 application, local safety score

  • Withdrawal rate [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    Withdrawal rates and discontinuations due to adverse events


Secondary Outcome Measures:
  • LD Half life (t½ ), time of LD plasma concentrations maintained above 1000 ng/ml, trough levels, Cmax, Tmax and AUC [ Time Frame: Up to 2 days ] [ Designated as safety issue: No ]
    LD PK profile after oral LD dosing administered with or without ND0612:


Estimated Enrollment: 8
Study Start Date: December 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: levodopa and carbidopa
levodopa and carbidopa solution
 Drug: levodopa and carbidopa solution for SC administration
Placebo Comparator: placebo to levodopa and carbidopa
saline
 Drug: Placebo
Other Name: Saline

Detailed Description:

Design: single center, double-blind, randomized, placebo-controlled, crossover study.

Study Drug: Subcutaneous (SC), ND0612 (LD/CD solution) or placebo (saline) to be administered via a continuously via the CRONO Five SC pump. A 1-week washout period will apply between the treatments.

Population: Eight (8) PD subjects.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Men and women with idiopathic Parkinson's disease
  • Subjects must experience motor fluctuations associated with LD/CD dosing
  • Modified Hoehn and Yahr stage < 5
  • Subjects must be taking optimized and stable levodopa/dopa decarboxylase inhibitor therapy
  • Women must be postmenopausal, surgically sterilized, or using adequate birth control. Women of childbearing potential must have a negative pregnancy test (serum beta-HCG) at screening.
  • Subjects must be age 30 or older.
  • Subjects must be willing and able to give informed consent.

Main Exclusion Criteria:

  • Subjects with a clinically significant or unstable medical or surgical condition
  • Subjects with clinically significant psychiatric illness.
  • Pre-menopausal women, not using birth control method.
  • Subjects who have taken experimental medications within 60 days prior to baseline.
  • Subject who have undergone a neurosurgical intervention for Parkinson's disease (e.g., pallidotomy, thalamotomy, transplantation and deep brain stimulation).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01725802

Contacts
Contact: Yoseph Caraco, MD 02-6779373

Locations
Israel
Hadassah Medical Center Not yet recruiting
Jerusalem, Israel
Contact: Yoseph Caraco, MD     02-6779373     CARACO@hadassah.org.il    
Principal Investigator: Yoseph Caraco, MD            
Sponsors and Collaborators
NeuroDerm Ltd.
  More Information

No publications provided

Responsible Party: NeuroDerm Ltd.
ClinicalTrials.gov Identifier: NCT01725802     History of Changes
Other Study ID Numbers: ND0612/002
Study First Received: November 4, 2012
Last Updated: November 8, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Carbidopa
Levodopa
 Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013