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

Phase 2

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: XP21279 and carbidopa (experimental); Drug: Sinemet (comparator); Drug: Placebo for XP21279 and carbidopa; Drug: Placebo for Sinemet

• Registration Number: NCT01171313
• Lead Sponsor: XenoPort, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-26
• Study First Submitted QC: 2010-07-27
• Study First Posted: 2010-07-28
• Primary Completion: 2011-10
• Study Completion: 2011-12
• Disposition First Submitted: 2013-01-31
• Disposition First Submitted QC: 2013-01-31
• Disposition First Posted: 2013-02-04
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. 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.

2. 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment sequence 2	Sinemet (comparator)	Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Treatment sequence 4	Sinemet (comparator)	Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Treatment sequence 3	Placebo for XP21279 and carbidopa	Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Treatment sequence 3	Placebo for Sinemet	Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Treatment sequence 2	Placebo for Sinemet	Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Treatment sequence 3	XP21279 and carbidopa (experimental)	Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Treatment sequence 1	Sinemet (comparator)	Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Treatment sequence 1	Placebo for Sinemet	Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Treatment sequence 3	Sinemet (comparator)	Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Treatment sequence 4	Placebo for XP21279 and carbidopa	Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Treatment sequence 1	Placebo for XP21279 and carbidopa	Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Treatment sequence 1	XP21279 and carbidopa (experimental)	Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Treatment sequence 2	XP21279 and carbidopa (experimental)	Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Treatment sequence 2	Placebo for XP21279 and carbidopa	Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Treatment sequence 4	Placebo for Sinemet	Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Treatment sequence 4	XP21279 and carbidopa (experimental)	Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in mean daily "off" time at end of double-blind maintenance treatment periods.	2 weeks

Secondary Outcome Measures

Name	Time	Method
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	2 weeks

Trial Locations

Locations (1)

XenoPort Clinical Site; 🇺🇸 Houston, Texas, United States