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A Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor Fluctuations

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ClinicalTrials.gov Identifier: NCT02782481
Recruitment Status : Terminated (Decision to change the study design)
First Posted : May 25, 2016
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
NeuroDerm Ltd.

Study Description
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Brief Summary:
This is a multicenter, randomized, double blind, placebo controlled parallel group clinical study. Following a screening period of up to 28 days, eligible subjects will be randomized to receive adjunct treatment to oral LD/DDI (Dopa Decarboxylase Inhibitor) with continuous subcutaneous infusion of ND0612 or matching placebo for 16 weeks.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: ND0612 Drug: Placebo Phase 3

Detailed Description:

This phase III randomized, double-blind, placebo controlled, parallel group clinical study will be conducted in 150 subjects with idiopathic PD who are experiencing motor complications despite optimized anti-PD therapy.

The study will investigate the efficacy, safety and tolerability of continuous SC infusion (16 weeks) of ND0612 compared with placebo infusion. The treatment period will be comprised of a 4-week adjustment period during which time the ND0612 infusion dose will remain constant and the oral LD/DDI dose can be decreased or increased back up to the Baseline levels. All other anti-PD treatments must remain constant. During the maintenance period (Weeks 5 to 16) all anti-PD medication including the ND0612/placebo should remain constant.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Group Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor Fluctuations
Actual Study Start Date : August 2016
Actual Primary Completion Date : October 15, 2018
Actual Study Completion Date : October 15, 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: ND0612 High dose (Levodopa/Carbidopa solution)
High dose ND0612 SC infusion over 24 h
 Drug: ND0612
Other Name: Levodopa/Carbidopa solution
Experimental: ND0612 Low dose (Levodopa/Carbidopa solution)
Low dose ND0612 SC infusion over 24 h
 Drug: ND0612
Other Name: Levodopa/Carbidopa solution
Placebo Comparator: Placebo
Placebo SC infusion over 24 h
 Drug: Placebo
Other Name: Placebo solution


Outcome Measures
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Primary Outcome Measures :
  1. The change from Baseline to Week 16 in the mean percentage of "OFF" time during waking hours, based on patient's home diary assessments [ Time Frame: baseline to week 16 ]

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

Key Inclusion Criteria:

  1. Male and female PD subjects of any race aged 30-80 years
  2. PD diagnosis consistent with the UK Brain Bank Criteria.
  3. Modified Hoehn & Yahr scale in "ON" state ≤3
  4. Subjects must experience motor fluctuations and experience an average of at least 2 hours daily in the "OFF" state
  5. Taking at least 4 doses/day of IR LD/DDI (or at least 3 doses/day of Rytary) and taking, or having taken therapeutic doses of at least 2 other classes of anti-PD medications.
  6. Subjects must be on stable doses of all their anti-PD medications for at least 28 days before Baseline (Day 1).
  7. Subject and/or study partner must demonstrate ability to keep accurate diary entries of PD symptoms ("ON-OFF" diaries) with at least 75% concordance with the study rater by the end of the diary training session at the end of the screening period.
  8. Mini Mental State Examination (MMSE) score >26.
  9. 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.

Key Exclusion Criteria:

  1. Atypical or secondary parkinsonism.
  2. Psychosis or hallucinations in past 6 months.
  3. Subjects with a clinically significant or unstable medical, surgical, psychiatric condition or laboratory abnormalities which, in the opinion of the Investigator or the EAC, represents a safety risk, makes the subject unsuitable for study entry or potentially unable to complete all aspects of the study.
  4. Clinically significant ECG abnormalities.
  5. Renal or liver dysfunction that may alter drug metabolism including Screening visit serum levels of creatinine >1.3 mg/dL, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2x upper limit of normal (ULN), total bilirubin >2.5 mg/dL.
  6. Positive serum serology for Hepatitits B Virus (HBV), Hepatitits C Virus (HCV) or Human Immunodeficiency Virus (HIV) at the Screening visit
  7. 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
  8. Use of prohibited medications as per protocol
  9. Subjects who have previously undergone treatment for PD with a neurosurgical intervention (e.g., pallidotomy, thalamotomy, transplantation, deep brain stimulation procedures), Duodopa/Duopa, or continuous dopaminergic or apomorphine infusion.
Contacts and Locations
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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): NCT02782481


Locations
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Israel
Haddasah Ein Kerem Medical center
Jerusalem, Israel
Sponsors and Collaborators
NeuroDerm Ltd.
More Information
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Responsible Party: NeuroDerm Ltd.
ClinicalTrials.gov Identifier: NCT02782481     History of Changes
Other Study ID Numbers: ND0612L-007
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
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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