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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02096601
• Other study ID #: ND0612/004
• Status: Completed
• Phase: Phase 1
• Start date: August 11, 2014
• Est. completion date: March 15, 2015

Study information

• Verified date: April 2024
• Source: NeuroDerm Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 15, 2015
• Est. primary completion date: March 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• LD/CD SC solution
Levodopa/carbidopa SC solution
• Entacapone
Entacapone 200 mg oral tablet

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem
Israel	Tel Aviv Medical Center	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
NeuroDerm Ltd.	Michael J. Fox Foundation for Parkinson's Research

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events frequency		Up to 6 weeks
Primary	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
Primary	Tolerability: Number of patients who discontinued due to adverse events		Up to 6 weeks