A Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients Receiving ND0612

NCT01883505 | Completed Phase 2

• 1 other identifier: ND0612/003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

This phase 2a randomized double blind placebo controlled, in 30 Parkinson's disease (PD) subjects who are treated with oral levodopa/carbidopa (LD/CD) and suffer from motor fluctuations. The aim of the study is to determine the safety, tolerability, the levodopa pharmacokinetics, the need for oral LD dose adjustment and the usability of the ambulatory drug delivery pump following repeated dosing of ND0612 in a conventional home setting in Parkinson's disease patients. Safety and tolerability, pharmacokinetic profile of levodopa and carbidopa, pump usability and the potential clinical effect of ND0612 will be explored in subjects with PD and motor fluctuations.

Conditions

Parkinson's Disease

Keywords

Motor fluctuations; levodopa pharmacokinetics; levodopa and carbidopa solution; continuous subcutaneous delivery; Patch-pump

Outcome Measures

Primary Outcomes (3)

• Safety

  1\. Incidence and frequency of adverse events, of dopaminergic adverse events 2. Adverse events reporting related to the ND0612 subcutaneous administration, Draize score 3. Vital signs, physical exam, Laboratory measurements

  14 days

• Levodopa pharmacokinetics (LD PK)

  LD PK parameters: Cmax, Area under the Curve (AUC), T\>1000ng/ml, through levels at baseline and during treatment at 14 days.

  1hr and 2hr predose, 0h, 0.5 hr, 1hr, 1.5hr, 2hr, 3hr, 4hr, 5hr, 6hr, 7hr, 8hr, 9hr and 10hr hours post oral LD dose

• Tolerability

  Withdrawal rates and discontinuations due to adverse events

  14 days

Secondary Outcomes (2)

• LD dose adjustment

  14 days

• Pump Usability

  14 days

Study Arms (2)

ND0612

EXPERIMENTAL

levodopa and carbidopa solution

Drug: Levodopa and carbidopa

Placebo

PLACEBO COMPARATOR

Saline

Drug: Placebo

Interventions

Levodopa and carbidopa DRUG

Subcutaneous continuous administration

Also known as: Levodopa and carbidopa or saline

ND0612

Placebo DRUG

Subcutaneous continuous administration

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women with idiopathic Parkinson's disease
• Subjects must experience motor fluctuations associated with LD/CD dosing
• Modified Hoehn and Yahr stage \< 5
• Subjects must be taking optimized and stable levodopa/dopa decarboxylase inhibitor therapy
• Subjects who are treated with dopaminergic agonists and other anti-PD drugs should be on stable doses
• Women must be postmenopausal, surgically sterilized, or using adequate birth control. Women of childbearing potential must have a negative pregnancy test (serum beta-HCG) at screening.
• Subjects must be age 30 or older.
• Subjects must be willing and able to give informed consent

You may not qualify if:

• Subjects treated with entacapone, tolcapone, stalevo or controlled release formulation of levodopa/carbidopa.
• Subjects with a clinically significant or unstable medical or surgical condition
• History of melanoma or significant skin disorders
• Subjects with significant cognitive impairment
• Subjects treated with unstable doses of dopaminergic agonists, anticholinergics, Monoamine oxidase (MAO)-B inhibitors, or antipsychotics
• Subjects with clinically significant psychiatric illness
• Subjects with a history of alcohol or substance abuse
• Subjects who have taken experimental medications within 60 days prior to baseline.
• Subject who have undergone a neurosurgical intervention for Parkinson's disease (e.g., pallidotomy, thalamotomy, transplantation and deep brain stimulation).
• Subjects with severe disabling dyskinesias.
• Subjects with hearing, visual or motor impairments that prevent them from using the pump or reacting effectively to errors

Sponsors & Collaborators

• NeuroDerm Ltd.: lead

Study Sites (3)

Hadassah Medical Center

Jerusalem, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Tel Aviv Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

carbidopa, levodopa drug combination; Levodopa; Carbidopa; Sodium Chloride

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine; Methyldopa; Hydrazines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2013
• First Posted: June 21, 2013
• Study Start: January 6, 2014
• Primary Completion: April 26, 2015
• Study Completion: April 26, 2015
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

IL (3)