Early Stage Parkinson's Disease Clinical Trial
Official title:
A Phase II, Dose Ranging, Randomized, Double Blind, Placebo-controlled, Multi-center, Pilot Study to Assess the Safety, Tolerability, Efficacy and Pharmacokinetics of Aplindore in Patients With Early Stage Parkinson's Disease
The purpose of this study is to demonstrate the safety, tolerability, efficacy and
pharmacokinetics of aplindore in patients with early stage Parkinson's Disease (PD) who are
not currently taking any dopamine agonists or who are able to wash off dopamine agonists for
14 days prior to baseline. Efficacy will be assessed using the UPDRS questionnaire including
part 3 of the UPDRS (Motor). their level of sleepiness on a standardized rating scale
(Epworth Sleepiness Scale) and their level of nausea daily.
Safety endpoints will include adverse events (AEs), clinical laboratory data, vital signs
(blood pressure, orthostatic blood pressure and heart rate), ECGs, physical examinations and
self rated scales.
The purpose of this study is to demonstrate the safety, tolerability, efficacy and
pharmacokinetics of aplindore in 5 groups of 8 patients each with early stage Parkinson's
Disease (PD) based on Modified Hoehn and Yahr 1-3, who are not currently taking any dopamine
agonists or who are able to wash off dopamine agonists for 14 days prior to baseline. Of the
8 patients in each cohort, 6 will be randomized to receive aplindore and two will receive
placebo. The initial cohort of patients will be in the study unit from day -1 through day 15
(~2 weeks). After a review of safety labs and ECGs for Day -1, patients will begin twice a
day dosing of investigational product on Day 1 with dosing to be given at within 30 minutes
of completing breakfast and dinner, approximately 0700 and 1900.
A full UPDRS evaluation will be conducted at screen and on days -1, 7 and 14. In addition
part 3 of the UPDRS (Motor) will be collected daily 2 hours after the morning dose of
aplindore/placebo. At screening through discharge patients will be asked to self rate their
level of sleepiness on a standardized rating scale (Epworth Sleepiness Scale) and their
level of nausea daily 2 hours after the time of the morning dose of aplindore/placebo.
Safety endpoints will include adverse events (AEs), clinical laboratory data, vital signs
(blood pressure, orthostatic blood pressure and heart rate), ECGs, physical examinations and
self rated scales.
This study is a Phase II, dose-ranging, multi-center, placebo-controlled, double-blind,
titration study to determine the safety, tolerability, efficacy and pharmacokinetics of
aplindore in 5 groups of 8 patients each with early stage Parkinson's Disease (PD) based on
Modified Hoehn and Yahr 1-3, who are not currently taking any dopamine agonists or who are
able to wash off dopamine agonists for 14 days prior to baseline. Of the 8 patients in each
cohort, 6 will be randomized to receive aplindore and two will receive placebo. The minimum
number of patients required to initiate a cohort is 6 patients (4 randomized to aplindore
and 2 to placebo). The patients in each cohort will be randomized in blocks of 4. Each site
will recruit a full cohort of 6-8 patients per dose-titration regimen. There will be no
sharing of cohorts/dose regimens across sites.
Early PD patients will be screened and 6-8 eligible patients will be housed in the study
unit from day -1 through day 15 or until dismissed by the investigator. After a repeat of
safety labs and ECG, patients will begin q12h dosing of investigational product (IP) with
dosing to be given at within 30 minutes of completing breakfast and dinner, approximately
0700 and 1900 starting on Day 1. Doses will be escalated according to a predefined schedule.
Two hours after each morning dose, a UPDRS part III will be performed. Safety will be
ascertained by adverse events, ECGs, orthostatic vitals, physical and neurological exams,
safety labs, Epworth Sleepiness Scale and Non Motor Symptoms Questionnaires. One blood
sample for PK will be taken on each escalation day, 11 samples at steady state. ECGs and
vital signs (semi-reclined and standing) will be collected each day at 2 hours post morning
dosing. Adverse events will be collected throughout the inpatient stay. Patients will be
down titrated upon reaching an intolerable dose. Patients on prior dopaminergic medications
will resume their prior therapies on Day 15. Those patients not on prior dopaminergic
medications will be down titrated over 5-7 days in the research clinic. Outpatient safety
follow up will be 7-21 days after the last dose of study medication.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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