A Safety, Tolerability and Pharmacokinetic Study of ND0611 on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Parkinson's Disease Patients

A Phase I/II, Single-center, Randomized, Cross-over, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Pharmacokinetic Profile of Levodopa Following Administration of Subcutaneous Continuously-delivered Carbidopa Solution (ND0611) on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01229332

Enrollment

Registered

2010-10-27

Start date

2011-01-31

Completion date

2011-11-30

Last updated

2011-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Motor fluctuations levodopa pharmacokinetics carbidopa solution continuous

Brief summary

A cross-over study, where ND0611 or placebo will be tested on top of 3 different LD/CD dosage forms. Safety and tolerability, pharmacokinetic profile of levodopa and carbidopa and the potential clinical effect of ND0611 will be explored in subjects with PD and motor fluctuations.

Interventions

DRUGSaline

Continuous 24 h administration

DRUGCarbidopa

Continuous 24 h administration

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Men and women with idiopathic Parkinson's disease 2. Subjects must experience motor fluctuations associated with LD/CD dosing 3. Modified Hoehn and Yahr stage \< 5 4. Subjects must be taking optimized and stable levodopa/dopa decarboxylase inhibitor therapy 5. Women must be postmenopausal, surgically sterilized, or using adequate birth control. Women of childbearing potential must have a negative pregnancy test (serum beta-HCG) at screening. 6. Subjects must be age 30 or older. 7. Subjects must be willing and able to give informed consent.

Exclusion criteria

1. Subjects with a clinically significant or unstable medical or surgical condition 2. Subjects with clinically significant psychiatric illness. 3. Pre-menopausal women, not using birth control method. 4. Subjects who have taken experimental medications within 60 days prior to baseline. 5. Subject who have undergone a neurosurgical intervention for Parkinson's disease (e.g., pallidotomy, thalamotomy, transplantation and deep brain stimulation).

Design outcomes

Primary

Measure	Time frame	Description
Incidence and frequency of adverse events, withdrawal rate	Up to 2 days	1\. Incidence and frequency of adverse events, of dopaminergic adverse events 2. Adverse events reporting related to the ND0611 Omnipod® application, Draize score 2. Withdrawal rates and discontinuations due to adverse events

Secondary

Measure	Time frame	Description
Half life (t½ ), Cmax, Tmax and AUC of levodopa and carbidopa in the plasma	Up to 2 days	Pharmacokinetic profile of plasma LD and CD: Half life (t½ ), Cmax, Tmax and AUC

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026