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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-11

Study Completion Date

2015-03-15

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ND0612L Low LD Dose

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

Group Type EXPERIMENTAL

LD/CD SC solution

Intervention Type DRUG

Levodopa/carbidopa SC solution

Entacapone

Intervention Type DRUG

Entacapone 200 mg oral tablet

ND0612H High LD Dose

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

Group Type EXPERIMENTAL

LD/CD SC solution

Intervention Type DRUG

Levodopa/carbidopa SC solution

Entacapone

Intervention Type DRUG

Entacapone 200 mg oral tablet

Interventions

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LD/CD SC solution

Levodopa/carbidopa SC solution

Intervention Type DRUG

Entacapone

Entacapone 200 mg oral tablet

Intervention Type DRUG

Other Intervention Names

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ND0612

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No