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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

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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.

March 29, 2016
April 1, 2016
December 27, 2017
May 2016
February 2018   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT02726386 on ClinicalTrials.gov Archive Site
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Not Provided
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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
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
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.
This phase open-label safety study will be conducted in approximately 100 subjects.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Parkinson's Disease
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 1
    Regimen 1 of ND0612 (LD/CD solution) continuous subcutaneous infusion over 24 hrs
    Intervention: Drug: ND0612
  • Experimental: ND0612 (Levodopa/Carbidopa solution) - Regimen 2
    Regimen 2 of ND0612 (LD/CD solution) continuous subcutaneous for over 14-16 hrs .
    Intervention: Drug: ND0612
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
Same as current
May 2018
February 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
30 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Czechia,   France,   Germany,   Israel,   Italy,   Poland,   Spain,   United States
 
 
NCT02726386
ND0612H-012
Yes
Not Provided
Not Provided
NeuroDerm Ltd.
NeuroDerm Ltd.
Not Provided
Not Provided
NeuroDerm Ltd.
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP