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Completed

NCT Number: NCT01229332

A Safety, Tolerability and Pharmacokinetic Study of ND0611 on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Parkinson's Disease Patients

A cross-over study, where ND0611 or placebo will be tested on top of 3 different LD/CD dosage forms. Safety and tolerability, pharmacokinetic profile of levodopa and carbidopa and the potential clinical effect of ND0611 will be explored in subjects with PD and motor fluctuations.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hadassah Medical Center

Jerusalem, Israel

Who can participate

Healthy volunteers accepted: No

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

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.

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).

Treatment and study plan

Saline

Drug

Continuous 24 h administration

Carbidopa

Drug

Continuous 24 h administration

Primary outcomes

  1. Incidence and frequency of adverse events, withdrawal rate

    Time frame: Up to 2 days

    • Incidence and frequency of adverse events, of dopaminergic adverse events 2. Adverse events reporting related to the ND0611 Omnipod® application, Draize score 2. Withdrawal rates and discontinuations due to adverse events

Secondary outcomes

  1. Half life (t½ ), Cmax, Tmax and AUC of levodopa and carbidopa in the plasma

    Time frame: Up to 2 days

    Pharmacokinetic profile of plasma LD and CD: Half life (t½ ), Cmax, Tmax and AUC

  2. Half life (t½ ), Cmax, Tmax and AUC of levodopa and carbidopa in the plasma

    Time frame: Up to 2 days

    Pharmacokinetics profile of plasma LD and CD: Half life (t½ ), Cmax, Tmax and AUC

Sponsors and collaborators

Lead sponsor

NeuroDerm Ltd.

Industry

Registry information

Official study title

A Phase I/II, Single-center, Randomized, Cross-over, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Pharmacokinetic Profile of Levodopa Following Administration of Subcutaneous Continuously-delivered Carbidopa Solution (ND0611) on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 27, 2010
Registry last updated
Dec 6, 2011

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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