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8110 Gatehouse Road, Falls Church, VA 22042

A Phase 3, Twelve-week Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to Its Individual Components in Subjects With Early Parkinson's Disease and to a Calibration Arm of Pramipexole ER.

General Information

Age Group

Adults ages 35 to 80

Status

Active

Protocol Number

P2B001/003

Background Information

Brief Summary: A Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects With Early Parkinson's Disease and to a Calibration Arm of Pramipexole ER.

Detailed Description: A total of 525 eligible subjects with early untreated Parkinson's disease (PD), will be randomized to 4 treatment groups. Each subject will participate in the study for approximately 18 weeks including a 30 day screening period, 12 week treatment period, and 2 weeks follow-up period.

Offered At

Inova Medical Group – Neurology I
1500 N Beauregard Street, Suite #300
Alexandria, VA 22311

Principal Investigator

Drew Falconer, MD

Eligibility Information

  • Subject has Parkinson's disease consistent with the UK Brain Bank Criteria and must have bradykinesia with sequence effect. If rest tremor does not exist must have prominent asymmetry of motor function.
  • Subject with disease duration less than 3 years since diagnosis.
  • Subject has a H&Y stage score of < 3.
  • Subject has a MMSE score ≥ 26.

Ineligibility Information

  • Subject has an atypical parkinsonian syndrome or secondary parkinsonism
  • Subject has previous exposure to levodopa or a dopamine agonist for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 2 months prior to the baseline visit.
  • Subject has previous exposure to a MAO-B inhibitor for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 3 months prior to the baseline visit.
  • Subject who has taken anticholinergic drugs for PD or amantadine for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 1 month prior to the baseline visit.
  • Subject has moderate (Child-Pugh categorization B, score 7-9) or severe (Child-Pugh categorization C, score 10-15) hepatic impairment.

For more information, visit clinicaltrials.gov