NCT01634243

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

5 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

January 1, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 6, 2012

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

March 19, 2014

Completed
Last Updated

March 19, 2014

Status Verified

February 1, 2014

Enrollment Period

1.3 years

First QC Date

June 27, 2012

Results QC Date

February 3, 2014

Last Update Submit

February 3, 2014

Conditions

Parkinson's Disease

Keywords

SPM 962rotigotineParkinson's disease

Outcome Measures

Primary Outcomes (1)

  • Maintenance Dose of the SPM962

    The maintenance dose of the SPM 962 was examined based on the safety and efficacy.

    Up to 12 weeks after dosing

Secondary Outcomes (10)

  • Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters

    Up to 12 weeks after dosing

  • Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy

    baseline, 12 weeks after dosing

  • UPDRS Part 3 Sum Score for Advanced Parkinson's Disease With Concomitant L-dopa Therapy

    baseline, 12 weeks after dosing

  • UPDRS Part 2 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy

    Baseline, 12 weeks after dosing

  • UPDRS Part 3 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy

    Baseline, 12 weeks after dosing

  • +5 more secondary outcomes

Study Arms (1)

SPM 962

EXPERIMENTAL

SPM 962 transdermal patch

Drug: SPM 962

Interventions

SPM 962DRUG

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

Also known as: rotigotine
SPM 962

Eligibility Criteria

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

You may qualify if:

  • For subject with early and advanced Parkinson's disease
  • 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.
  • Gender and inpatient-outpatient status are not specified.
  • For subject with early Parkinson's disease
  • Hoehn \& Yahr stage 3 or less.
  • Subject who has not taken L-dopa within 28 days prior to initial administration of SPM 962.
  • For subject with dvanced Parkinson's disease
  • Hoehn \& Yahr stage 2-4.
  • Subject is on a stable dose of L-dopa with no change in daily dose or dosing regimen for at least 7 days prior to the initial treatment of SPM 962.
  • Subject has any of the following problematic symptoms; 1) Wearing off phenomenon 2) On and off phenomenon 3) Not well controlled with L-dopa due to adverse effect 4) Weakening of L-dopa efficacy.

You may not qualify if:

  • Subject is on other dopamine agonist treatment within 7 days prior to the initial treatment. Subject is on cabergoline treatment within 14 days prior to the initial treatment.
  • Subject has psychiatric symptoms, e.g. confusion, hallucination, delusion, excitation, delirium, abnormal behavior.
  • Subject has orthostatic hypotension.
  • Subject has a history of epilepsy, convulsion and other.
  • Subject has a complication of serious cardiac disorder or has the history.
  • Subject has arrhythmia and treated with class 1a antiarrhythmic drugs (e.g. quinidine, procainamide etc.) or class 3 antiarrhythmic drugs (e.g. amiodarone, sotalol etc.).
  • At screening and baseline, subject develops serious ECG abnormality. Subjects has QTc-interval \>450 msec at screening. Subject has QTc-interval \>450 msec in males and \>470 msec in females at baseline.
  • Subject has congenital long QT syndrome.
  • Subject has hypokalaemia.
  • 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).
  • Subject has BUN \>= 25 mg/dL or serum creatinine \>= 2.0 mg/dl.
  • Subject has a history of allergic reaction to topical agents such as transdermal patch.
  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

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

rotigotine

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., Ltd.
+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 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2012

First Posted

July 6, 2012

Study Start

January 1, 2005

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

March 19, 2014

Results First Posted

March 19, 2014

Record last verified: 2014-02

Locations

JP(5)