A Long-Term Extension Trial From Phase… | Clinical Trial

Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Chubu Region, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject completed the preceding trial 243-07-001 (NCT00537485)

Exclusion criteria

Subject discontinued from the preceding trial 243-07-001.
Subject had a serious adverse event which association with the investigational drug was not ruled out during trial 243-07-001.
Subject has a persistent serious adverse event at the baseline, which was observed and association with the investigational drug was ruled out during trial 243-07-001.
Subject had persistent hallucination or delusion during trial 243-07-001.
Subject has psychiatric conditions such as confusion, excitation, delirium, abnormal behaviour at the baseline.
Subject has orthostatic hypotension or a systolic blood pressure (SBP) <= 100 mmHg and has a decrease of SBP from spine to standing position >= 30 mmHg at baseline.
Subject has a history of epilepsy, convulsion etc. during trial 243-07-001.
Subject develops serious ECG abnormality at the baseline.
Subject has QTc-interval >= 500 msec at the baseline or subject has an increase of QTc-interval >= 60 msec from the baseline in the trial 243-07-001 and has a QTc-interval > 470 msec in female or > 450 msec in male at the baseline.
Subject has a serum potassium level < 3.5 mEq/L at the end of the taper period in trial 243-07-001.
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 the end of the period in trial 243-07-001.
Subject has BUN >= 30 mg/dL or serum creatinine >= 2.0 mg/dl at the end of the taper period in trial 243-07-001.
Subject who plans pregnancy during the trial.
Subject has dementia.
Subject is unable to give consent.
Subject is judged to be inappropriate for this trial by the investigator for the reasons other than above.

Treatment and study plan

SPM 962

Drug

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

Other names: rotigotine

Primary outcomes

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

Time frame: Up to 55 weeks after dosing

Incidence and severity of adverse events, vital signs, and laboratory parameters up to 54 weeks after dosing.

*decrease in difference between supine and standing systolic blood pressure
Skin Irritation Score of the Application Site

Time frame: Up to 55 weeks after dosing

Skin irritation score of the application site were evaluated according to the criteria below. The worst score throughout the treatment period was used in the analysis.

-: no reaction, ±: mild erythema, +: erythema, ++: erythema and Oedema, +++: erythema and oedema and rash papular, or serous papule, or vesicles, ++++: bullosum

Secondary outcomes

Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score

Time frame: Baseline, Up to 54 weeks after dosing

Mean change (LOCF) from baseline in Total of UPDRS Part 2 sum score and Part 3 sum up to 54 weeks after dosingUPDRS 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.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

An Open-label Long-term Extension Trial From Phase II/III of SPM962 (243-07-001) in Early Parkinson's Disease Patients With Non-concomitant Treatment of L-dopa

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Jun 27, 2012
Registry last updated: Mar 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed