CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 64 enrolled
Drug / intervention
SPM 962drug
Likely dose
SPM 962 36.0 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01634243
NCT01634243Phase 2Completed
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A Open-label Dose-ranging Study for SPM 962 in Parkinson's Disease Patients

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Jul 6, 2012·Updated Mar 19, 2014

In Brief

A Phase 2 clinical trial evaluating SPM 962 for Parkinson's Disease. Completed, enrolled 64 participants across 5 sites.

Detailed Summary

The primary objective of this trial is to establish the maximum maintenance dose of SPM 962 in patients with Parkinson's disease in a multi-center, uncontrolled, open-label study by conducting safety evaluation of each patient following once-daily transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg. (The administration period will consist of a standard 8-week dose-titration period, 4-week dose-maintenance period, and a dose de-escalation period) Exploratory evaluation of each patient's maintenance dose will also be conducted with attention to patient safety. The relationship of pharmacokinetics, safety, and efficacy will also be examined.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 6, 2012
Enrollment StartJan 1, 2005
Primary CompletionMay 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.0 years ago

Interventions

SPM 962drug

SPM 962 transdermal patch once a daily up to 36.0 mg/day