A Safety, Tolerability, and Plasma Concentration Study of Levodopa/Carbidopa Subcutaneous Solution (ND0612) in Parkinson's Disease (PD) Patients

NCT01725802 | Completed Phase 1

• 1 other identifier: ND0612/002
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

In this Phase I/IIa study, the effect of continuous subcutaneous administration of LD/CD solution (ND0612) on the safety and PK profile of LD will be examined.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (2)

• Incidence and frequency of adverse events

  1. Incidence and frequency of adverse events 2. Adverse events reporting related to the ND0612 application, local safety score

  up to 8 weeks

• Withdrawal rate

  Withdrawal rates and discontinuations due to adverse events

  2 days

Secondary Outcomes (1)

• LD Half life (t½ ), time of LD plasma concentrations maintained above 1000 ng/ml, trough levels, Cmax, Tmax and AUC

  Up to 2 days

Study Arms (2)

Treatment sequence A

EXPERIMENTAL

Period 1. ND0612; Period 2. Placebo

Drug: Levodopa/carbidopa solution for SC administration; Drug: Placebo

Treatment sequence B

EXPERIMENTAL

Period 1. Placebo; Period 2. ND0612

Drug: Levodopa/carbidopa solution for SC administration; Drug: Placebo

Interventions

Levodopa/carbidopa solution for SC administration DRUG

Also known as: ND0612

Treatment sequence A; Treatment sequence B

Placebo DRUG

Also known as: Saline

Treatment sequence A; Treatment sequence B

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
• 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 with a clinically significant or unstable medical or surgical condition
• Subjects with clinically significant psychiatric illness.
• Pre-menopausal women, not using birth control method.
• 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).

Sponsors & Collaborators

• NeuroDerm Ltd.: lead

Study Sites (1)

Hadassah Medical Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Levodopa; 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; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2012
• First Posted: November 14, 2012
• Study Start: December 16, 2012
• Primary Completion: February 26, 2013
• Study Completion: February 26, 2013
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

IL (1)