A Long-Term Extension Trial From of SPM 962 in Advanced Parkinson's Disease Patients

NCT ID: NCT01631825

Last Updated: 2014-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 321 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2012-06-30

Brief Summary

• To investigate the safety of once-daily repeated transdermal administration of SPM 962 within a dose range of 4.5 to 36.0 mg/day (54-week treatment period) in Parkinson's disease (PD) patients treated concomitantly with L-dopa in a multi-center, open-label uncontrolled study.
• To investigate efficacy of SPM 962 in an exploratory manner.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SPM 962

SPM 962 transdermal patch

Group Type: EXPERIMENTAL

SPM 962

Intervention Type: DRUG

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

Interventions

SPM 962

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

Intervention Type: DRUG

Other Intervention Names

rotigotine

Eligibility Criteria

Inclusion Criteria

• Subject completed the preceding trial 243-08-001.

Exclusion Criteria

• Subject discontinued from the preceding trial 243-08-001.
• Subject had a serious adverse event which association with the investigational drug was not ruled out during trial 243-08-001.
• Subject has a persistent serious adverse event at the baseline, which was observed and association with the investigational drug was ruled out during trial 243-08-001.
• Subject had persistent confusion, hallucination, delusion or excitation during trial 243-08-001.
• Subject has abnormal behavior such as obsessive-compulsive disorder and delusion in 243-08-001 study.
• Subject showed serious or extensive application site reactions beyond the application site in the 243-08-001 study.
• 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 243-08-001.
• 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 243-08-001 and has a QTc-interval > 470 msec in female or > 450 msec in male at the baseline.
• Subject had a serum potassium level < 3.5 mEq/L at the end of the taper period in trial 243-08-001.
• 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 243-08-001.
• Subject had BUN >= 30 mg/dL or serum creatinine >= 2.0 mg/dl at the end of the taper period in trial 243-08-001.
• Subject who plans pregnancy during the trial.
• Subject is unable to give consent.
• Subject is judged to be inappropriate for this trial by the investigator for the reasons other than above.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyoji Imaoka, Mr

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Co., Ltd.

Locations

Chubu Region, , Japan

Chugoku Region, , Japan

Hokkaido Region, , Japan

Kanto Region, , Japan

Kinki Region, , Japan

Kyushu Region, , Japan

Shikoku Region, , Japan

Tohoku Region, , Japan

Countries

Japan

Other Identifiers

243-08-002

Identifier Type: -

Identifier Source: org_study_id