- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02096601
A Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients
January 17, 2024 updated by: NeuroDerm Ltd.
A Phase I/II Pharmacokinetic (PK) Study of ND0612, a Liquid Formulation of Levodopa/Carbidopa (LD/CD), Delivered as a Continuous Subcutaneous in Parkinson's Disease (PD) Patients Treated With LD
An open label phase I/IIa study to evaluate the safety and tolerability of 6 different doses/ infusion rates of subcutaneous (SC) ND0612 solution in PD patients; to determine if continuous delivery of levodopa and carbidopa can provide reduced variability in plasma concentration; to test and compare the PK profile of high and low concentrations of CD; to assess preliminary efficacy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Jerusalem, Israel
- Hadassah Medical Center
-
Tel Aviv, Israel
- Tel Aviv Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male and female PD patients of any race aged 30 to 80 years
- PD diagnosis consistent with the UK PD Society Brain Bank criteria.
- Stable doses of anti PD drugs for at least 30 days
- PD patients with well-defined morning "OFF" and a good response to LD
- MMSE score > 26
- No clinically significant medical, psychiatric or laboratory abnormalities
Exclusion Criteria:
- Atypical or secondary Parkinsonism.
- Acute psychosis or hallucinations.
- Subjects treated with neuroleptics
- History of melanoma or significant skin disorders.
- Prior neurosurgical procedure for PD.
- Patients with a history of drug abuse or alcoholism
- Clinically significant ECG abnormalities.
- Renal or liver dysfunction
- Subjects who have participated in another clinical study within 30 days
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ND0612
Levodopa and carbidopa SC solution
|
Levodopa and carbidopa SC solution
Other Names:
|
Active Comparator: Oral levodopa and carbidopa
|
Oral levodopa and carbidopa
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events frequency
Time Frame: Up to 6 weeks
|
Up to 6 weeks
|
LD, CD and 3-OMD PK analysis from sample taken on Days 3, 4 and 5 will be used to determine the Fluctuation Index, its CV, AUC, Cmin, Cmax, and tmax.
Time Frame: Days 1, 2, 3 and 4
|
Days 1, 2, 3 and 4
|
Tolerability: Number of patients who discontinued due to adverse events
Time Frame: Up to 6 weeks
|
Up to 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 11, 2014
Primary Completion (Actual)
March 15, 2015
Study Completion (Actual)
March 15, 2015
Study Registration Dates
First Submitted
March 18, 2014
First Submitted That Met QC Criteria
March 23, 2014
First Posted (Estimated)
March 26, 2014
Study Record Updates
Last Update Posted (Actual)
January 18, 2024
Last Update Submitted That Met QC Criteria
January 17, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Aromatic Amino Acid Decarboxylase Inhibitors
- Levodopa
- Carbidopa
Other Study ID Numbers
- ND0612/004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson's Disease
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
Assistance Publique - Hôpitaux de ParisFrance Parkinson AssociationUnknownHealthy Controls | Parkinson's Disease With LRRK2 Mutation | Parkinson's Disease Without LRRK2 MutationFrance
-
University Hospital, GrenobleCompletedParkinson's Disease (Disorder)France
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
Universidade Federal de PernambucoCompletedParkinson's Disease.Brazil
-
Shanghai East HospitalShanghai iCELL Biotechnology Co., Ltd, Shanghai, ChinaRecruitingIdiopathic Parkinson's DiseaseChina
-
Beijing Tiantan HospitalRecruitingPD - Parkinson's DiseaseChina
-
AbbVieActive, not recruitingParkinson's Disease (PD)United States, Australia
-
AbbVieCompletedParkinson's Disease (PD)United States, Australia
-
BlueRock TherapeuticsMemorial Sloan Kettering Cancer CenterActive, not recruitingAdvanced Parkinson's DiseaseUnited States, Canada
Clinical Trials on Levodopa and carbidopa SC solution
-
University of MinnesotaNot yet recruitingIdiopathic Parkinson DiseaseUnited States
-
NeuroDerm Ltd.Completed
-
NeuroDerm Ltd.Quotient ClinicalCompletedParkinson's DiseaseUnited Kingdom
-
NeuroDerm Ltd.CompletedParkinson's DiseaseUnited States, Israel, Italy, Austria
-
AbbVie (prior sponsor, Abbott)Completed
-
Centre for Addiction and Mental HealthCompleted
-
Snyder, Robert W., M.D., Ph.D., P.C.WithdrawnAge-related Macular DegenerationUnited States
-
Academisch Medisch Centrum - Universiteit van Amsterdam...ZonMw: The Netherlands Organisation for Health Research and DevelopmentCompleted
-
Novartis PharmaceuticalsOrion Corporation, Orion PharmaCompletedParkinson's DiseaseUnited States, Switzerland, Germany, Finland, Greece, Italy, Spain, United Kingdom, Canada, France, Turkey, Belgium, Sweden, Austria