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A Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients

NCT01628926 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2014-05-23

Study results available
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Summary

* To demonstrate the non-inferiority of SPM 962 to ropinirole in terms of efficacy in order to confirm clinical value of SPM 962.
* To demonstrate the superiority of SPM 962 to placebo in terms of efficacy.
* To investigate the tolerability and safety of SPM 962 up to 36.0 mg/day.

Conditions

Interventions

DRUG

SPM 962

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

DRUG

Ropinirole

Ropinirole oral administration TID up to 15.0 mg/day

DRUG

Placebo

SPM962-placebo patch and Ropinirole-placebo tab

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kyoji Imaoka, Mr · Otsuka Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • Japan

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01628926 on ClinicalTrials.gov