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

Phase 1

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: LD/CD SC solution; Drug: Entacapone

• Registration Number: NCT02096601
• Lead Sponsor: NeuroDerm Ltd.

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).

Detailed 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.

Study Timeline

• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-23
• Study First Posted: 2014-03-26
• Study Start: 2014-08-11
• Primary Completion: 2015-03-15
• Study Completion: 2015-03-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ND0612L Low LD Dose	LD/CD SC solution	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
ND0612H High LD Dose	LD/CD SC solution	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
ND0612H High LD Dose	Entacapone	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
ND0612L Low LD Dose	Entacapone	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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Tel Aviv Medical Center; 🇮🇱 Tel Aviv, Israel

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel