NCT01628926

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 27, 2012

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

May 23, 2014

Completed
Last Updated

May 23, 2014

Status Verified

April 1, 2014

Enrollment Period

1.9 years

First QC Date

June 24, 2012

Results QC Date

February 3, 2014

Last Update Submit

April 23, 2014

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Unified Parkinson's Disease Rating Score (UPDRS) Part 3 Sum Score

    Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) at 16 weeks after dosing. UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.

    baseline, 16 weeks after dosing

Secondary Outcomes (13)

  • UPDRS Part 3 Sum Score

    baseline, 8 and 10 weeks after dosing

  • UPDRS Part 2 Sum Score

    Baseline, 16 weeks after dosing

  • Off Time

    Baseline, 16 weeks after dosing

  • Parkinson's Disease Sleep Scale-2 (PDSS-2)

    Baseline, 16 weeks after dosing

  • On Time

    Baseline, 16 weeks after dosing

  • +8 more secondary outcomes

Study Arms (3)

SPM 962

EXPERIMENTAL

SPM 962 transdermal patch

Drug: SPM 962

Ropinirole

ACTIVE COMPARATOR

Ropinirole tablet

Drug: Ropinirole

Placebo

PLACEBO COMPARATOR

SPM962 placebo patch and Ropinirole placebo tab

Drug: Placebo

Interventions

SPM 962DRUG

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

SPM 962
RopiniroleDRUG

Ropinirole oral administration TID up to 15.0 mg/day

Ropinirole
PlaceboDRUG

SPM962-placebo patch and Ropinirole-placebo tab

Placebo

Eligibility Criteria

Age30 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject diagnosed as having Parkinson's disease in accordance with "Diagnostic Criteria established by the Research Committee of MHLW-specified Intractable Neurodegenerative Diseases (1995)".
  • Subject is 30 and more and less than 80 years of age at the time of informed consent.
  • Hoehn \& Yahr stage 2-4 (on time).
  • Total UPDRS Part 3 score is over 10 at screening test (on time).
  • Subject is on a stable dose of L-dopa with no change in daily dose or dosing regimen for at least 28 days prior to the initial treatment of SPM 962.
  • Subject has any of the following problematic symptoms; 1) Wearing off phenomenon (including frozen gait at off time and dystonia at off time) 2) On and off phenomenon 3) Delayed-on and/or No-on phenomenon 4) Dyskinesia 5) Not well controlled with L-dopa.

You may not qualify if:

  • Subject who has previously participated in a clinical trial of SPM962 and taken the investigational product (IP).
  • Subject has psychiatric symptoms, e.g. confusion, hallucination, delusion, excitation, delirium, abnormal behavior at screening test or baseline.
  • Subject whose SBP declines by at least 30 mmHg from supine to standing position based on the orthostatic hypotension assessment, or subject who develops orthostatic hypotension at baseline.
  • Subject has a history of epilepsy, convulsion and other.
  • Subject who has complications or a history of serious cardiac diseases or arrhythmia (eg, congestive heart failure of class 3 or 4 in the NYHA classification, second or third degree atrioventricular block, complete left bundle branch block, sick sinus syndrome, ventricular fibrillation, myocardial infarction within 12 months prior to the screening test, or a complication of angina pectoris).
  • Subjects has QTc-interval \>450 msec twice at screening. Subject has a the average QTc-interval from two ECGs \>450 msec in males and \>470 msec in females at baseline.
  • Subject has congenital long QT syndrome.
  • Subject whose serum potassium level is \< 3.5mEq/L at the screening test.
  • Subject has a total bilirubin \>= 3.0 mg/dL or AST(GOT) or ALT(GPT) greater than 2.5 times of the upper limit of the reference range (or \>= 100 IU/L) at screening test, or suffers complications of active phase of chronic hepatitis or liver cirrhosis.
  • Subject has BUN \>= 30 mg/dL or serum creatinine \>= 2.0 mg/dl at screening test.
  • Subject has a history of allergic reaction to topical agents such as transdermal patch.
  • Subject has a history of known intolerance/hypersensitivity to ropinirole and/or adverse drug reactions that prevent subject from receiving treatment.
  • Subject is pregnant or nursing or woman who plans pregnancy during the trial.
  • Subject is receiving therapy with prohibited drug specified in the study protocol.
  • Subject has a history of pallidotomy, thalamotomy, deep brain stimulation or fetal tissue transplant.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Chubu Region, Japan

Location

Unknown Facility

Chugoku Region, Japan

Location

Unknown Facility

Hokkaido Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kinki Region, Japan

Location

Unknown Facility

Kyushu Region, Japan

Location

Unknown Facility

Shikoku Region, Japan

Location

Unknown Facility

Tohoku Region, Japan

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

ropinirole

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Results Point of Contact

Title
Director of Clinical Research and Development
Organization
Otsuka Pharmaceutical Co, Lts.
+81-3-6361-7366

Study Officials

  • Kyoji Imaoka, Mr

    Otsuka Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2012

First Posted

June 27, 2012

Study Start

June 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 23, 2014

Results First Posted

May 23, 2014

Record last verified: 2014-04

Locations

JP(8)