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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by NeuroDerm Ltd.
Sponsor:
Information provided by (Responsible Party):
NeuroDerm Ltd.
ClinicalTrials.gov Identifier:
NCT02726386
First received: March 29, 2016
Last updated: April 18, 2017
Last verified: September 2016
  Purpose
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 Intervention Phase
Parkinson's Disease
Drug: ND0612
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by NeuroDerm Ltd.:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: May 2016
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02726386

Contacts
Contact: Yael Ullmann +972-8-9462729 ullmann.y@neuroderm.com
Contact: Yael Cohen +972-8-9462729 yael@neuroderm.com

  Show 35 Study Locations
Sponsors and Collaborators
NeuroDerm Ltd.
  More Information

Responsible Party: NeuroDerm Ltd.
ClinicalTrials.gov Identifier: NCT02726386     History of Changes
Other Study ID Numbers: ND0612H-012
Study First Received: March 29, 2016
Last Updated: April 18, 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

ClinicalTrials.gov processed this record on April 28, 2017