Clinical trial

A Multicenter, Open-Label, Randomized, Dose-Finding Study Testing the Safety, Tolerability, and Pharmacokinetics (PK) of ND0612, a Liquid Formulation of Levodopa/Carbidopa (LD/CD) Delivered as a Continuous Subcutaneous Infusion (SC) in Parkinson's Disease (PD) Patients Treated With LD

NCT02096601

Name

ND0612/004

Description

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).

Trial arms

Trial start

2014-08-11

Estimated PCD

2015-03-15

Trial end

2015-03-15

Status

Completed

Phase

Early phase I

Treatment

LD/CD SC solution

Levodopa/carbidopa SC solution

Arms:

ND0612H High LD Dose, ND0612L Low LD Dose

Other names:

ND0612

Entacapone

Entacapone 200 mg oral tablet

Arms:

ND0612H High LD Dose, ND0612L Low LD Dose

Size

Primary endpoint

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

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 16, 'type': 'ACTUAL'}}

Updated at

2024-04-29

1 organization

2 products

1 indication

Organization

Product

Indication

Product