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

Primary Purpose

Parkinson's Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Sinemet 25-100 Oral Tablet

XP21279

Carbidopa Pill

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).
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.
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:

History, signs, or symptoms suggesting the diagnosis of secondary or atypical Parkinsonism.
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.
Subjects who are dosing with Sinemet® or carbidopa/levodopa during the night time.
Subjects who have significant neurological symptoms not accounted for by Parkinson's disease.
Subjects who are taking concomitantly COMT inhibitors (i.e., entacapone or tolcapone) or treated with Stalevo®, Sinemet® CR, or Madopar®/Prolopa® (levodopa/benserazide).

Sites / Locations

XenoPort Investigational Site
XenoPort Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Treatment Period A

Treatment Period B

Arm Description

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.

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®).

Outcomes

Primary Outcome Measures

to assess the pharmacokinetics of XP21279 sustained release formulation [administered with Lodosyn® (carbidopa)] and Sinemet® tablets in subjects with Parkinson's disease.

To establish a pharmacokinetic profile for XP21279

to assess the Pharmacodynamics of XP21279 sustained release formulation [administered with Lodosyn® (carbidopa)] and Sinemet® tablets in subjects with Parkinson's disease.

Changes in The Brief Parkinsonism Rating Scale during treatment

to assess the safety of XP21279 sustained release formulation [administered with Lodosyn® (carbidopa)] and Sinemet® tablets in subjects with Parkinson's disease.

Observe values and changes in clinical laboratory and vital sign parameters describe by time of collection for each treatment period.

Secondary Outcome Measures

the dose correspondence between XP21279 and Sinemet® will be explored to guide dose selection for future studies in the target population

comparison of PK levels and doses.

Full Information

NCT ID

NCT00914602

First Posted

June 3, 2009

Last Updated

April 30, 2021

Sponsor

XenoPort, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00914602

Brief Title

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

Official Title

An Exploratory Pharmacokinetic, Pharmacodynamic and Safety Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease Subjects With Motor Fluctuations

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

May 2009 (Actual)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

XenoPort, Inc.

4. Oversight

5. Study Description

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®).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Period A

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Treatment Period B

Arm Type

Experimental

Arm Description

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®).

Intervention Type

Drug

Intervention Name(s)

Sinemet 25-100 Oral Tablet

Other Intervention Name(s)

Carbidopa / Levodopa

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

XP21279

Other Intervention Name(s)

XP21279 sustained related

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Carbidopa Pill

Other Intervention Name(s)

Lodosyn

Primary Outcome Measure Information:

Title

to assess the pharmacokinetics of XP21279 sustained release formulation [administered with Lodosyn® (carbidopa)] and Sinemet® tablets in subjects with Parkinson's disease.

Description

To establish a pharmacokinetic profile for XP21279

Time Frame

4 weeks

Title

to assess the Pharmacodynamics of XP21279 sustained release formulation [administered with Lodosyn® (carbidopa)] and Sinemet® tablets in subjects with Parkinson's disease.

Description

Changes in The Brief Parkinsonism Rating Scale during treatment

Time Frame

4 weeks

Title

to assess the safety of XP21279 sustained release formulation [administered with Lodosyn® (carbidopa)] and Sinemet® tablets in subjects with Parkinson's disease.

Description

Observe values and changes in clinical laboratory and vital sign parameters describe by time of collection for each treatment period.

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

the dose correspondence between XP21279 and Sinemet® will be explored to guide dose selection for future studies in the target population

Description

comparison of PK levels and doses.

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). 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. 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: History, signs, or symptoms suggesting the diagnosis of secondary or atypical Parkinsonism. 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. Subjects who are dosing with Sinemet® or carbidopa/levodopa during the night time. Subjects who have significant neurological symptoms not accounted for by Parkinson's disease. Subjects who are taking concomitantly COMT inhibitors (i.e., entacapone or tolcapone) or treated with Stalevo®, Sinemet® CR, or Madopar®/Prolopa® (levodopa/benserazide).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steve D Caras, MD

Organizational Affiliation

Arbor Pharma

Official's Role

Study Chair

Facility Information:

Facility Name

XenoPort Investigational Site

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

Facility Name

XenoPort Investigational Site

City

Bingham Farms

State/Province

Michigan

ZIP/Postal Code

48025

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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