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

NeuroDerm

Status and phase: Completed; Phase 1

Conditions: Parkinson's Disease

Treatments: Drug: LD/CD SC solution; Drug: Entacapone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02096601

ND0612/004

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 16 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

ND0612L Low LD Dose

Experimental group

Description:

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

Treatment:

Drug: Entacapone

Drug: LD/CD SC solution

ND0612H High LD Dose

Experimental group

Description:

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

Treatment:

Drug: Entacapone

Drug: LD/CD SC solution