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

NCT00914602 | Completed Phase 1

• 1 other identifier: XP-C-058
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (3)

• 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

  4 weeks

• 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

  4 weeks

• 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.

  4 weeks

Secondary Outcomes (1)

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

  4 weeks

Study Arms (2)

Treatment Period A

ACTIVE COMPARATOR

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.

Drug: Sinemet 25-100 Oral Tablet

Treatment Period B

EXPERIMENTAL

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®).

Drug: XP21279; Drug: Carbidopa Pill

Interventions

Sinemet 25-100 Oral Tablet DRUG

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

Also known as: Carbidopa / Levodopa

Treatment Period A

XP21279 DRUG

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

Also known as: XP21279 sustained related

Treatment Period B

Carbidopa Pill DRUG

Also known as: Lodosyn

Treatment Period B

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• XenoPort, Inc.: lead

Study Sites (2)

XenoPort Investigational Site

Peoria, Arizona, 85381, United States

Location

XenoPort Investigational Site

Bingham Farms, Michigan, 48025, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

carbidopa, levodopa drug combination; 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)

Methyldopa; Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Hydrazines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Steve D Caras, MD

  Arbor Pharma

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2009
• First Posted: June 5, 2009
• Study Start: May 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: May 5, 2021

Record last verified: 2021-04

Locations

US (2)