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

XenoPort

Status and phase: Completed; Phase 2

Conditions: Parkinson's Disease

Treatments: Drug: Placebo for XP21279 and carbidopa; Drug: Sinemet (comparator); Drug: Placebo for Sinemet; Drug: XP21279 and carbidopa (experimental)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01171313

XenoPort (Other Identifier)

XP-C-069

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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®.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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35 participants in 4 patient groups

Treatment sequence 1

Experimental group

Description:

Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.

Treatment:

Drug: XP21279 and carbidopa (experimental)

Drug: Sinemet (comparator)

Drug: Placebo for Sinemet

Drug: Placebo for XP21279 and carbidopa

Treatment sequence 2

Experimental group

Description:

Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.

Treatment:

Drug: XP21279 and carbidopa (experimental)

Drug: Sinemet (comparator)

Drug: Placebo for Sinemet

Drug: Placebo for XP21279 and carbidopa

Treatment sequence 3

Experimental group

Description:

Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.

Treatment:

Drug: XP21279 and carbidopa (experimental)

Drug: Sinemet (comparator)

Drug: Placebo for Sinemet

Drug: Placebo for XP21279 and carbidopa

Treatment sequence 4

Experimental group

Description:

Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.

Treatment:

Drug: XP21279 and carbidopa (experimental)

Drug: Sinemet (comparator)

Drug: Placebo for Sinemet

Drug: Placebo for XP21279 and carbidopa