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A Clinical Study in Advanced Parkinson's Disease Investigating the Long Term Safety of ND0612 Administered as a Continuous SC Infusion

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 : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
NeuroDerm Ltd.

Tracking Information
First Submitted Date  ICMJE March 29, 2016
First Posted Date  ICMJE April 1, 2016
Last Update Posted Date November 21, 2018
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02726386 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study in Advanced Parkinson's Disease Investigating the Long Term Safety of ND0612 Administered as a Continuous SC Infusion
Official Title  ICMJE 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
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.
Detailed Description This phase open-label safety study will be conducted in approximately 100 subjects.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE Drug: ND0612
ND0612, a solution of levodopa/carbidopa (LD/CD) delivered continuously subcutaneously (SC) via an infusion pump system
Study Arms  ICMJE
  • Experimental: ND0612 (Levodopa/Carbidopa solution) - Regimen 1
    Regimen 1 of ND0612 continuous SC infusion over 24 hrs
    Intervention: Drug: ND0612
  • Experimental: ND0612 (Levodopa/Carbidopa solution) - Regimen 3
    Regimen 3 of ND0612 continuous SC for over 16 hrs
    Intervention: Drug: ND0612
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 22, 2018)
210
Original Estimated Enrollment  ICMJE
 (submitted: March 31, 2016)
100
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female PD subjects of any race aged at least 30 years who have signed an IRB/EC-approved ICF.
  • 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 LD/DDI (or at least 3 doses/day of Rytary) and taking, or have attempted to take, at least 1 other PD treatment for at least 30 days.
  • 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 SC apomorphine injections/infusion but must have stopped continuous apomorphine 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 (e.g., oral contraceptives, 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. Alternatively, true abstinence is acceptable when it is in line with the subject's preferred and usual lifestyle. If a subject is usually not sexually active but becomes active, the subject and sexual partner must comply with the contraceptive requirements detailed above.
  • Willing and able to administer the SC infusion alone or with the assistance of a study partner after a screening period of up to 40 days and willing and able to comply with study requirements.
  • Subjects should have a named study partner.

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.
  • Any malignancy in the 5 years prior to randomization (excluding basal cell carcinoma of the skin or cervical carcinoma in situ that have been successfully treated).
  • Positive serum serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) at the Screening visit.
  • 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.
  • Current participation in a clinical trial with an investigational product or past participation within the last 30 days before Day 1.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Czechia,   France,   Germany,   Israel,   Italy,   Poland,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02726386
Other Study ID Numbers  ICMJE ND0612H-012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NeuroDerm Ltd.
Study Sponsor  ICMJE NeuroDerm Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account NeuroDerm Ltd.
Verification Date November 2018

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