A Dose Finding Study of Preladenant (SCH 420814) for the Treatment of Parkinson's Disease (PD) in Japanese Patients (P06402)
Source: ClinicalTrials.gov NCT01294800 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean "Off" Time (Hours Per Day) at Week 12 |
-1.2; -1.0; -0.9; -0.5 | 0.0564 |
| PRIMARY Number of Participants Who Experienced an Adverse Event (AE) |
53; 60; 69; 55 | — |
| PRIMARY Number of Participants Who Discontinued Study Treatment Due to an AE |
6; 6; 12; 5 | — |
| SECONDARY Percentage of Participants With ≥30% Reduction in "Off" Time at Week 12 |
34.5; 34.6; 24.6; 28.9 | 0.404 |
| SECONDARY Change From Baseline in Mean "On" Time Without Troublesome Dyskinesias (Hours Per Day) at Week 12 |
1.3; 1.0; 1.0; 0.5 | 0.0509 |
Eligibility Criteria
Inclusion Criteria
- Must have a diagnosis of idiopathic PD based on the United Kingdom Parkinson's Disease Society Brain Bank Criteria, judged to be moderate to severe
- Must have received prior therapy with L-dopa for more than 1 year before Screening
- Must have been on a stable, optimal dopaminergic treatment regimen, defined as maximum
therapeutic effect achieved with available anti-Parkinsonian treatment, for at least the 4 weeks immediately before randomization
- If receiving one or more of the following adjunctive treatments: amantadine, anticholinergics, catechol-O-methyltransferase inhibitors, dopa decarboxylase inhibitors, dopamine agonists, entacapone, L-dopa, must have been on a stable regimen of treatment for at least the 4 weeks immediately before randomization
- Hoehn and Yahr stage must be ≥ 2.5 and ≤ 4 following optimum titration of treatment medications at Screening
- Must be experiencing motor fluctuations with or without dyskinesias following optimum titration of
treatment medications and within the 4 weeks immediately before Screening
- Must be experiencing a minimum of 2 hours/day of "off" time as estimated by the investigator
and supported by the symptom diary (Daily Diary) at the Diary Training Visit
- With or without the help of a caregiver, must be capable of maintaining an accurate and
complete symptom diary (Daily Diary) as assessed at the Diary Training Visit
- Must have results of Screening clinical laboratory tests (complete blood count [CBC], blood
chemistries, and urinalysis) within normal limits or clinically acceptable to the investigator at Screening
- Must have results of a physical examination within normal limits or clinically acceptable limits
to the investigator
- Must be able to adhere to dose and visit schedules
- Females of child-bearing potential must have a negative serum pregnancy test (human chorionic
gonadotropin [hCG]) at Screening and must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for 2 weeks after stopping the medication
Exclusion Criteria
- Must not have a form of drug-induced or atypical parkinsonism, cognitive impairment, bipolar disorder, schizophrenia, or other psychotic disorder
- Must not have had surgery for PD
- Must not have an untreated major depressive disorder meeting Diagnostic and Statistical Manual
of Mental Disorders IV Text Revision (DSM-IV-TR) criteria
- Must not be at imminent risk of self-harm or harm to others, in the investigator's opinion based on
clinical interview
- Must not have participated in any studies using preladenant
- Must not have allergy/sensitivity to preladenant or any of its excipients
- Must not have used any investigational drugs or participated in any other clinical trial within 90 days of Screening
Data sourced from ClinicalTrials.gov (NCT01294800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.