A Safety, Tolerability, and Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients

NCT02096601 | Completed Phase 1

• 1 other identifier: ND0612/004
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

An open-label randomized study to evaluate the Safety, Tolerability, and PK of Low and High single doses of ND0612 (i.e. LD/CD ratio 60/7.5 mg/mL and 60/14 mg/mL), as well as the combination with oral Entacapone (concomitant catechol-O-methyl transferase \[COMT\] inhibitor) in PD subjects with well-defined morning "OFF" and a good response to LD. Exploratory efficacy parameters were collected (early evidence of effectiveness as part of Phase 1).

Conditions

Parkinson's Disease

Keywords

Motor fluctuations; levodopa pharmacokinetics; levodopa and carbidopa solution; continuous subcutaneous delivery

Outcome Measures

Primary Outcomes (3)

• Adverse events frequency

  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.

  Days 1, 2, 3 and 4

• Tolerability: Number of patients who discontinued due to adverse events

  Up to 6 weeks

Study Arms (2)

ND0612L Low LD Dose

EXPERIMENTAL

LD daily dose equals to 115 mg administered over 8 hours SC infusion: * LD/CD 60/7.5 mg/mL on Study Day 3 * LD/CD 60/14 mg/mL on Study Day 4 * LD/CD 60/14 mg/mL and Entacapone 200 mg every 4 hours on Study Day 5

Drug: LD/CD SC solution; Drug: Entacapone

ND0612H High LD Dose

EXPERIMENTAL

LD daily dose equals to 307 mg administered over 8 hours SC infusion: * LD/CD 60/7.5 mg/mL on Study Day 3 * LD/CD 60/14 mg/mL on Study Day 4 * LD/CD 60/14 mg/mL and Entacapone 200 mg every 4 hours on Study Day 5

Drug: LD/CD SC solution; Drug: Entacapone

Interventions

LD/CD SC solution DRUG

Levodopa/carbidopa SC solution

Also known as: ND0612

ND0612H High LD Dose; ND0612L Low LD Dose

Entacapone DRUG

Entacapone 200 mg oral tablet

ND0612H High LD Dose; ND0612L Low LD Dose

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NeuroDerm Ltd.: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (2)

Hadassah Medical Center

Jerusalem, Israel

Location

Tel Aviv Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

entacapone

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 26, 2014
• Study Start: August 11, 2014
• Primary Completion: March 15, 2015
• Study Completion: March 15, 2015
• Last Updated: April 29, 2024

Record last verified: 2024-04

Locations

IL (2)