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Completed

NCT Number: NCT01171313

A Efficacy, Safety and Pharmacokinetic Study of XP21279 and Sinemet® in Parkinson's Disease Subjects

The purpose of the study is to assess the efficacy and safety of XP21279/Carbidopa in comparison to Sinemet as well as evaluate the pharmacokinetics (PK) of levodopa after administration of XP21279/Carbidopa and Sinemet and to explore exposure-response relationships in a subset of subjects.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

XenoPort Clinical Site, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must have predictable motor fluctuations of the wearing off type, defined by meeting the following criteria based on the on/off diaries recorded over 3 days in the Screening Period:
  • Wearing-off in at least half (50%) of inter-dose intervals between the first and the last daily doses averaged over the 3 diary days, and
  • An average daily "off" time of 2 hours after the first "on" of the day through awake time up to midnight.
  • Subjects must be on one of the following stable QID or 5 times daily regimens for at least 4 weeks prior to Screening: Sinemet® or carbidopa-levodopa, with a total daily dose ranging from 400 mg to 1000 mg of levodopa

Exclusion criteria

  • History, signs, or symptoms suggesting the diagnosis of secondary or atypical Parkinsonism.
  • Subject has moderately or severely disabling dyskinesias for greater than 25% of the waking day
  • Subjects who have significant neurological symptoms not accounted for by Parkinson's disease
  • Subjects who are taking Sinemet® CR, Parcopa®, concomitant COMT inhibitors (i.e., entacapone or tolcapone), Stalevo®, or benserazide containing levodopa preparations Madopar® or Prolopa®.

Treatment and study plan

XP21279 and carbidopa (experimental)

Drug

Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed XP21279 and Carbidopa

Sinemet (comparator)

Drug

Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed Sinemet.

Placebo for XP21279 and carbidopa

Drug

Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed placebo for XP21279 and carbidopa

Placebo for Sinemet

Drug

Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed placebo for Sinemet

Primary outcomes

  1. Change from Baseline in mean daily "off" time at end of double-blind maintenance treatment periods.

    Time frame: 2 weeks

Secondary outcomes

  1. Proportion of responders ("much improved" or "very much improved") on Investigator-rated and patient-rated CGI-I at end of double-blind Maintenance Treatment periods

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

XenoPort, Inc.

Industry

Registry information

Official study title

A Phase 2 Efficacy, Safety and Pharmacokinetic Study of XP21279 BL2 and Sinemet® in Parkinson's Disease Subjects With Motor Fluctuations

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 28, 2010
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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