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

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. Identifier: NCT02782481
Recruitment Status : Unknown
Verified May 2016 by NeuroDerm Ltd..
Recruitment status was:  Recruiting
First Posted : May 25, 2016
Last Update Posted : September 22, 2016
Information provided by (Responsible Party):
NeuroDerm Ltd.

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: ND0612 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 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
Study Start Date : August 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ND0612 (Levodopa/Carbidopa solution)
ND0612 SC infusion over 24 h
Drug: ND0612
Other Name: Levodopa/Carbidopa solution

Placebo Comparator: ND0612 Placebo
ND0612 Placebo SC infusion over 24 h
Drug: ND0612 Placebo
Other Name: Levodopa/Carbidopa Placebo solution

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 ]

Information from the National Library of Medicine

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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

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.

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 identifier (NCT number): NCT02782481

Contact: Edith Dekel +972-8-9462729
Contact: Yael Cohen +972-8-9462729

Haddasah Ein Kerem Medical center Recruiting
Jerusalem, Israel
Contact: David Arkadir, Dr.    972-2-6776943   
Contact: Sara Marciano, Mrs.    972-2-6776943   
Sponsors and Collaborators
NeuroDerm Ltd.

Responsible Party: NeuroDerm Ltd. Identifier: NCT02782481     History of Changes
Other Study ID Numbers: ND0612L-007
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: May 2016

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
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