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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NeuroDerm Ltd.
ClinicalTrials.gov Identifier:
NCT01229332
First received: October 3, 2010
Last updated: December 4, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
 Drug: Saline
Drug: Carbidopa
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

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, withdrawal rate [ Time Frame: Up to 2 days ] [ Designated as safety issue: Yes ]
    1. 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 Outcome Measures:
  • Half life (t½ ), Cmax, Tmax and AUC of levodopa and carbidopa in the plasma [ Time Frame: Up to 2 days ] [ Designated as safety issue: No ]
    Pharmacokinetic profile of plasma LD and CD: Half life (t½ ), Cmax, Tmax and AUC

  • Half life (t½ ), Cmax, Tmax and AUC of levodopa and carbidopa in the plasma [ Time Frame: Up to 2 days ] [ Designated as safety issue: No ]
    Pharmacokinetics profile of plasma LD and CD: Half life (t½ ), Cmax, Tmax and AUC


Enrollment: 24
Study Start Date: January 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Carbidopa Drug: Carbidopa
Continuous 24 h administration
Placebo Comparator: Placebo Drug: Saline
Continuous 24 h administration

  Eligibility

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

Inclusion Criteria:

  1. Men and women with idiopathic Parkinson's disease
  2. Subjects must experience motor fluctuations associated with LD/CD dosing
  3. Modified Hoehn and Yahr stage < 5
  4. Subjects must be taking optimized and stable levodopa/dopa decarboxylase inhibitor therapy
  5. 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.
  6. Subjects must be age 30 or older.
  7. Subjects must be willing and able to give informed consent.

Exclusion Criteria:

  1. Subjects with a clinically significant or unstable medical or surgical condition
  2. Subjects with clinically significant psychiatric illness.
  3. Pre-menopausal women, not using birth control method.
  4. Subjects who have taken experimental medications within 60 days prior to baseline.
  5. 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: NCT01229332

Locations
Israel
Hadassah Medical Center
Jerusalem, Israel
Sponsors and Collaborators
NeuroDerm Ltd.
  More Information

No publications provided

Responsible Party: NeuroDerm Ltd.
ClinicalTrials.gov Identifier: NCT01229332     History of Changes
Other Study ID Numbers: ND0611/002
Study First Received: October 3, 2010
Last Updated: December 4, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by NeuroDerm Ltd.:
Motor fluctuations levodopa pharmacokinetics carbidopa solution continuous

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 June 13, 2013