An Exploratory Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease Subjects

NCT ID: NCT00914602

Last Updated: 2021-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2010-01-31

Brief Summary

The purpose of the study is to assess the pharmacokinetics, pharmacodynamics, and safety of XP21279 sustained release formulation [administered with Lodosyn® (carbidopa)] and Sinemet® tablets in subjects with Parkinson's disease with Motor Fluctuations.

Detailed Description

This is a Phase 1/Phase 2 multiple-dose, multi-center, open-label, two period sequential-treatment study in subjects with Parkinson's disease to assess the pharmacokinetics, pharmacodynamics, and safety of XP21279 sustained release formulation [administered with Lodosyn® (carbidopa)] and Sinemet® tablets in subjects with Parkinson's disease and to explore dose correspondence between XP21279 and Sinemet® to guide dose selection for future studies in the target population (subjects with Parkinson's disease with motor fluctuations on Sinemet®).

Conditions

Parkinson's Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Period A

Treatment Period A: Sinemet® 25-100 treatment After screening all subjects will be placed on a fixed dosing Sinemet® time regimen for approximately 14 days.

Group Type: ACTIVE_COMPARATOR

Sinemet 25-100 Oral Tablet

Intervention Type: DRUG

After screening all subjects will be placed on a fixed dosing Sinemet® time regimen for approximately 14 days.

Treatment Period B

Multiple-Dose XP21279 (with Lodosyn®) treatment. Upon completion of Sinemet® treatment eligible subjects will be placed on a fixed dosing time regimen of XP21279 (with Lodosyn®).

Group Type: EXPERIMENTAL

XP21279

Intervention Type: DRUG

Upon completion of Sinemet® treatment eligible subjects will be placed on a fixed dosing time regimen of XP21279 (with Lodosyn®).

Carbidopa Pill

Intervention Type: DRUG

Interventions

Sinemet 25-100 Oral Tablet

After screening all subjects will be placed on a fixed dosing Sinemet® time regimen for approximately 14 days.

Intervention Type: DRUG

XP21279

Upon completion of Sinemet® treatment eligible subjects will be placed on a fixed dosing time regimen of XP21279 (with Lodosyn®).

Intervention Type: DRUG

Carbidopa Pill

Intervention Type: DRUG

Other Intervention Names

Carbidopa / Levodopa; XP21279 sustained related; Lodosyn

Eligibility Criteria

Inclusion Criteria

1. Subjects with a clinical diagnosis of idiopathic Parkinson's disease, confirmed by the presence of at least two cardinal signs of the disease (resting tremor, bradykinesia, rigidity).

2. Subjects must have predictable motor fluctuations of the wearing off type, defined by wearing off in at least 50% of inter-dose intervals between the first and the last daily doses as recorded on the on/off diary over 3 days (Days -4 to -2) in the Screening Period.

3. Subjects must be on stable TID or QID Sinemet® or carbidopa/levodopa regimens from morning through early evening, with a total daily dose ranging from 400 mg to 1000 mg of levodopa, for at least 1 week prior to Screening.

Exclusion Criteria

1. History, signs, or symptoms suggesting the diagnosis of secondary or atypical Parkinsonism.

2. Subject has greater than or equal to moderately disabling dyskinesias for greater than 25% of the waking day as assessed by a score of 2 or more on item 32 and a score of 2 or more on item 33 on the UPDRS at Screening.

3. Subjects who are dosing with Sinemet® or carbidopa/levodopa during the night time.

4. Subjects who have significant neurological symptoms not accounted for by Parkinson's disease.

5. Subjects who are taking concomitantly COMT inhibitors (i.e., entacapone or tolcapone) or treated with Stalevo®, Sinemet® CR, or Madopar®/Prolopa® (levodopa/benserazide).

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

XenoPort, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steve D Caras, MD

Role: STUDY_CHAIR

Arbor Pharma

Locations

XenoPort Investigational Site

Peoria, Arizona, United States

XenoPort Investigational Site

Bingham Farms, Michigan, United States

Countries

United States

Other Identifiers

XP-C-058

Identifier Type: -

Identifier Source: org_study_id