A Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients

NCT01628848 | Completed Phase 2 Results

• 2 other identifiers: 243-05-001JapicCTI-060287
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 7

Brief Summary

The primary objective of this study is to investigate efficacy and safety of SPM 962 in advanced Parkinson's Disease (PD) patients in a multi-center, placebo-controlled study following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg (12 weeks of dose titration/maintenance period). Recommended maintenance dose range is also to be investigated with distribution of the maintenance dose and accumulated response rate of efficacy.

Conditions

Parkinson's Disease

Keywords

SPM 962; rotigotine; Parkinson's disease; concomitant use of L-dopa

Outcome Measures

Primary Outcomes (1)

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

  Mean change (LOCF) from baseline in UPDRS Part 3 sum score at 12 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, 12 weeks after dosing

Secondary Outcomes (11)

• UPDRS Part 2 Sum Score (Average Score of on State and Off State)

  baseline, 12 weeks after dosing

• Off Time

  baseline, 12 weeks after dosing

• Effective Rate in UPDRS Part 3 Sum Score

  Baseline, 12 weeks after dosing

• UPDRS Part 1 Sum Score

  Baseline, 12 weeks after dosing

• Effective Rate in Off Time

  Baseline, 12 weeks after dosing.

Study Arms (2)

SPM 962

EXPERIMENTAL

SPM 962 transdermal patch

Drug: SPM 962

Placebo

PLACEBO COMPARATOR

Placebo transdermal patch

Drug: Placebo

Interventions

SPM 962 DRUG

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

SPM 962

Placebo DRUG

Placebo transdermal patch

Placebo

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 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 2) On and off phenomenon 3) Delayed-on and/or No-on phenomenon 4) Not well controlled with L-dopa due to adverse effect 5) Weakening of L-dopa efficacy.

You may not qualify if:

• Subject has previously participated in a trial with SPM 962.
• Subject is on other dopamine agonist treatment within 28 days prior to the initial treatment.
• Subject has psychiatric symptoms, e.g. confusion, hallucination, delusion, excitation, delirium, abnormal behavior at screening test or baseline.
• 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 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 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) at screening test.
• Subject has BUN \>= 25 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 is pregnant or nursing or woman who plans pregnancy during the trial.
• Subject is receiving therapy with prohibited drug specified in the study protocol.

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (7)

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

Shikoku 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

• 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: 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: August 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: March 19, 2014
• Results First Posted: March 19, 2014

Record last verified: 2014-02

Locations

JP (7)