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

NCT01229332 | Completed Phase 1

• 1 other identifier: ND0611/002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Motor fluctuations levodopa pharmacokinetics carbidopa solution continuous

Outcome Measures

Primary Outcomes (1)

• Incidence and frequency of adverse events, withdrawal rate

  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

  Up to 2 days

Secondary Outcomes (2)

• Half life (t½ ), Cmax, Tmax and AUC of levodopa and carbidopa in the plasma

  Up to 2 days

• Half life (t½ ), Cmax, Tmax and AUC of levodopa and carbidopa in the plasma

  Up to 2 days

Study Arms (2)

Carbidopa

PLACEBO COMPARATOR

Drug: Carbidopa

Placebo

PLACEBO COMPARATOR

Drug: Saline

Interventions

Saline DRUG

Continuous 24 h administration

Placebo

Carbidopa DRUG

Continuous 24 h administration

Carbidopa

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women with idiopathic Parkinson's disease
• Subjects must experience motor fluctuations associated with LD/CD dosing
• Modified Hoehn and Yahr stage \< 5
• Subjects must be taking optimized and stable levodopa/dopa decarboxylase inhibitor therapy
• 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.
• Subjects must be age 30 or older.
• Subjects must be willing and able to give informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• NeuroDerm Ltd.: lead

Study Sites (1)

Hadassah Medical Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Sodium Chloride; Carbidopa

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Methyldopa; Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Hydrazines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2010
• First Posted: October 27, 2010
• Study Start: January 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 6, 2011

Record last verified: 2011-12

Locations

IL (1)