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

Phase 1

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: Saline; Drug: Carbidopa

• Registration Number: NCT01229332
• Lead Sponsor: NeuroDerm Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-03
• Study First Submitted QC: 2010-10-26
• Study First Posted: 2010-10-27
• Study Start: 2011-01
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-04
• Last Update Posted: 2011-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Saline	-
Carbidopa	Carbidopa	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Half life (t½ ), Cmax, Tmax and AUC of levodopa and carbidopa in the plasma	Up to 2 days	Pharmacokinetics profile of plasma LD and CD: Half life (t½ ), Cmax, Tmax and AUC

Trial Locations

Locations (1)

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel