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Trial record 1 of 1 for:    ND0612H-012
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A Clinical Study Investigating Long Term Safety of ND0612, a Solution of Levodopa/Carbidopa Administered as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02726386
Recruitment Status : Active, not recruiting
First Posted : April 1, 2016
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):
NeuroDerm Ltd.

Brief Summary:
This is a multi-center, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa (LD/CD) delivered via a pump system as a continuous SC infusion in subjects with advanced Parkinson's Disease.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: ND0612 Phase 2

Detailed Description:
This phase open-label safety study will be conducted in approximately 100 subjects.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, International, Open-label, Safety Study of ND0612, a Solution of Levodopa/Carbidopa Delivered Via a Pump System as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson's Disease
Study Start Date : May 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: ND0612 (Levodopa/Carbidopa solution) - Regimen 1
Regimen 1 of ND0612 (LD/CD solution) continuous subcutaneous infusion over 24 hrs
Drug: ND0612
ND0612, a solution of levodopa/carbidopa (LD/CD) delivered continuously subcutaneously (SC) via an infusion pump system
Experimental: ND0612 (Levodopa/Carbidopa solution) - Regimen 2
Regimen 2 of ND0612 (LD/CD solution) continuous subcutaneous for over 14-16 hrs .
Drug: ND0612
ND0612, a solution of levodopa/carbidopa (LD/CD) delivered continuously subcutaneously (SC) via an infusion pump system



Primary Outcome Measures :
  1. Assess the long term safety (systemic and local) and tolerability of continuous subcutaneous infusion of ND0612 by adverse events, vital signs, local tolerability [ Time Frame: 12 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female ,Parkinson's disease subjects of any race aged 30 to 85 years .
  • PD diagnosis consistent with the UK Brain Bank Criteria.
  • Modified Hoehn & Yahr scale in "ON" state of stage ≤3.
  • Taking at least 4 doses/day of Levodopa (or at least 3 doses/day of Rytary) and taking, or have attempted to take, at least 1 other Parkinson's disease treatment for at least 30 days in the previous year.
  • Subjects must be stable on their anti-Parkinson's disease medications for at least 30 days before Day 1.
  • Subjects may have had prior exposure to Sub Cutaneous apomorphine injections/infusion but must have stopped administration at least 4 weeks before the screening visit. Treatment with apomorphine is prohibited during the entire ND0612 treatment period.
  • Must have a minimum of 2 hours of "OFF" time per day with predictable early morning "OFF" periods as estimated by the subject.
  • Must have predictable and well defined early morning "OFF" periods with a good response to Levodopa for treatment of the early morning "OFF" in the judgement of the investigator.
  • Mini Mental State Examination (MMSE) score >26.
  • No clinically significant medical, psychiatric or laboratory abnormalities which the investigator judges would be unsafe or non-compliant in the study.
  • Female subjects must be surgically sterile (hysterectomy, bilateral oophorectomy, or tubal ligation), postmenopausal (defined as cessation of menses for at least 1 year), or willing to practice a highly effective method of contraception. All female participants must be non-lactating and non-pregnant and have a negative urine pregnancy test at Screening and at Baseline. Female subjects of childbearing potential must practice a highly effective method of contraception ( oral contraceptives plus a barrier method of birth control [condoms with contraceptive foams, diaphragms with contraceptive jelly], intrauterine devices, partner with vasectomy), 1 month before enrollment, for the duration of the study, and 3 months after the last dose of study drug.
  • Willing and able to administer the subcutaneous infusion alone or with the assistance of a study partner after a screening period of 28 days and willing and able to comply with study requirements.

Exclusion Criteria:

For Cohort 1 and Cohort 2, the following exclusion criterion applies:

  • Previously unable to tolerate ND0612 and/or have experienced intolerable adverse drug reactions associated with its use, regardless of the dosing regimen administered.

For Cohort 2, the following exclusion criteria apply:

  • Atypical or secondary parkinsonism.
  • Acute psychosis or hallucinations in past 6 months.
  • Any relevant medical, surgical, or psychiatric condition, laboratory value, or concomitant medication which, in the opinion of the Investigator makes the subject unsuitable for study entry or potentially unable to complete all aspects of the study.
  • Prior neurosurgical procedure for Parkinson's disease, or duodopa treatment.
  • Subjects with a history of drug abuse or alcoholism within the past 12 months.
  • Clinically significant ECG rhythm abnormalities.
  • Renal or liver dysfunction that may alter drug metabolism including: serum creatinine >1.3 mg/dL, serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 x upper limit of normal (ULN), total serum bilirubin >2.5 mg/dL.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02726386


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Sponsors and Collaborators
NeuroDerm Ltd.

Responsible Party: NeuroDerm Ltd.
ClinicalTrials.gov Identifier: NCT02726386     History of Changes
Other Study ID Numbers: ND0612H-012
First Posted: April 1, 2016    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pharmaceutical Solutions
Levodopa
Carbidopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors