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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01171313
• Other study ID #: XP-C-069
• Secondary ID: XenoPort
• Status: Completed
• Phase: Phase 2
• Start date: July 2010
• Est. completion date: December 2011

Study information

• Verified date: February 2021
• Source: XenoPort, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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®.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• XP21279 and carbidopa (experimental)
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed XP21279 and Carbidopa
• Sinemet (comparator)
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed Sinemet.
• Placebo for XP21279 and carbidopa
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
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed placebo for Sinemet

Locations

Country	Name	City	State
United States	XenoPort Clinical Site	Bingham Farms	Michigan
United States	XenoPort Clinical Site	Houston	Texas
United States	XenoPort Clinical Site	Kansas City	Kansas
United States	XenoPort Clinical Site	Little Rock	Arkansas
United States	XenoPort Clinical Site	Long Beach	California
United States	XenoPort Clinical Site	Naples	Florida
United States	XenoPort Clinical Site	New Brunswick	New Jersey
United States	XenoPort Clinical Site	Phoenix	Arizona
United States	XenoPort Clinical Site	Sunnyvale	California
United States	XenoPort Clinical Site	Tampa	Florida
United States	XenoPort Clinical Site	Tulsa	Oklahoma
United States	XenoPort Clinical Site	West Bloomfield	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
XenoPort, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in mean daily "off" time at end of double-blind maintenance treatment periods.		2 weeks
Secondary	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