A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients

NCT00537485 | Completed Phase 2 Results

• 1 other identifier: 243-07-001
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 6

Brief Summary

To investigate superiority of SPM 962 over placebo in early Parkinson's disease patients in a multi-center, placebo-controlled, double-blind study following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg (12-week dose titration/maintenance period)

Conditions

Early Parkinson's Disease

Keywords

SPM 962; rotigotine; Parkinson's disease; monotherapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to the End of Maintenance Period in Total of Each Sum Score of UPDRS Part 2 and Part 3

  Mean change (LOCF) from baseline to the end of maintenance period in total of each sum score of UPDRS Part 2 and Part 3. 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 2 assesses 13 items and 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, end of maintenance period

Secondary Outcomes (9)

• Efficacy Rate in Total of Each Sum Score of UPDRS Part 2 and Part 3

  baseline, end of maintenance period

• Mean Change in UPDRS Part 2 Sum Score

  Baseline, every two weeks

• Efficacy Rate in UPDRS Part 2 Sum Score

  Baseline, every two weeks

• UPDRS Part 3 Sum Score

  Baseline, every two weeks

• Efficacy Rate in UPDRS Part 3 Sum Score

  Baseline, every two weeks

Study Arms (2)

1

EXPERIMENTAL

Drug: SPM 962

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

SPM 962 DRUG

transdermal application, 1 time per day

1

placebo DRUG

transdermal application, 1 time per day

2

Eligibility Criteria

• Age: 30 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 years \< \> 80 years at the time of informed consent
• Hoehn \& Yahr stage 1- 3
• Total of each sum score of UPDRS Part 2 and 3 is over 10 at screening test

You may not qualify if:

• Subject has previously participated in a trial with SPM 962
• Subject is on L-dopa treatment for total of over 6 months at the time of informed consent
• Subject has psychiatric symptoms, e.g. confusion, hallucination, delusion, excitation, delirium, abnormal behavior at screening test and baseline
• Subject has orthostatic hypotension
• Subject has a history of epilepsy, convulsion and other
• Subject has a complication of serious cardiac disorder/arrhythmia or has the history
• Subject has arrhythmia and treated with class 1a anti-arrhythmic drugs (e.g. quinidine, procainamide etc.) or class 3 anti-arrhythmic drugs (e.g. amiodarone, sotalol etc.)
• Subject has serious ECG abnormal at screening i.e.; 1) Subject has more than 450 msec of QTc values both in two measurements at screening test 2) Subject has more than 470 msec for females and more than 450 msec for males of mean QTc values of two measurements at baseline
• Subject has congenital long QT syndrome
• Subject has serum potassium of less than 3.5 mEq/L at screening test.
• Subject has total bilirubin of 3.0 mg/dL and above or AST(GOT), ALT(GPT) greater than 2.5 times (or 100 IU/L and above) of the clinical laboratory's upper limit of the reference range at screening test
• Subject has 30 mg/dL and above of BUN or 2.0 mg/dL and above of serum creatinine at screening test
• Subject has a history of allergy to topical medicine, e.g. transdermal patch
• Subject is pregnant, nursing, or is child bearing potential while the trial
• Subject is receiving therapy with prohibited drug specified in the study protocol

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (6)

Unknown Facility

Chubu 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

Tohoku Region, Japan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Director of Clinical Research and Development
• Organization: Otsuka Pharmaceutical Co., Ltd.

+81-3-6131-7366

Study Officials

• Katsuhisa Saito

  New Product Evaluation and Development

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: September 27, 2007
• First Posted: October 1, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 19, 2014
• Results First Posted: March 19, 2014

Record last verified: 2014-02

Locations

JP (6)