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

Phase 1CompletedNCT02096601

NeuroDerm Ltd.16 enrolled

Overview

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).

PD subjects were randomized in Low or High LD dose study group in 1:1 ratio. Each patient received singe doses ND0612 over 3 days: Day 1. LD/CD 60/7.5 mg/mL, Day 2. LD/CD 60/14 mg, and Day 3. LD/CD 60/14 mg/mL with Entacapone.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson's Disease

Interventions

LD/CD SC solutionDRUG

Levodopa/carbidopa SC solution

EntacaponeDRUG

Entacapone 200 mg oral tablet

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male and female PD patients of any race aged 30 to 80 years 2. PD diagnosis consistent with the UK PD Society Brain Bank criteria. 3. Stable doses of anti PD drugs for at least 30 days 4. PD patients with well-defined morning "OFF" and a good response to LD 5. MMSE score \> 26 6. No clinically significant medical, psychiatric or laboratory abnormalities Exclusion Criteria: 1. Atypical or secondary Parkinsonism. 2. Acute psychosis or hallucinations. 3. Subjects treated with neuroleptics 4. History of melanoma or significant skin disorders. 5. Prior neurosurgical procedure for PD. 6. Patients with a history of drug abuse or alcoholism 7. Clinically significant ECG abnormalities. 8. Renal or liver dysfunction 9. Subjects who have participated in another clinical study within 30 days

Locations (2)

Hadassah Medical Center

Jerusalem, Israel

Tel Aviv Medical Center

Tel Aviv, Israel

Outcomes

Primary Outcomes

Adverse events frequency

Time frame: 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

Tolerability: Number of patients who discontinued due to adverse events

Time frame: Up to 6 weeks

Data from ClinicalTrials.gov

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