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

NCT01631825 | Completed Phase 3 Results

• 1 other identifier: 243-08-002
• Study Type: interventional
• Target: 321
• Locations: 1 country
• Sites: 8

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  The safety of the long-term SPM 962 treatment was examined based on the incidence and severity of AEs, vital signs, and laboratory parameters. AEs of special interest (1-3) are defined as below: 1. sudden onset of sleep 2. obsessive-compulsive disorder or impulse-control disorder 3. hallucination, delusion Application site reaction is scored as -, ±, +, ++, +++, or ++++. More + indicates a greater severity of symptoms. The worst score obtained throughout the evaluation period was to be assessed.

  Up to 55 weeks after dosing

Secondary Outcomes (16)

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

  Baseline, Up to 54 weeks after dosing

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

  Baseline, up to 54 weeks after dosing

• Absolute Time Spent "Off"

  Baseline, up to 54 weeks after dosing

• UPDRS Part 1 Sum Score

  Baseline, up to 54 weeks after dosing

• UPDRS Part 2 Sum Score (On State)

  Baseline, up to 54 weeks after dosing

Study Arms (1)

SPM 962

EXPERIMENTAL

SPM 962 transdermal patch

Drug: SPM 962

Interventions

SPM 962 DRUG

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

Also known as: rotigotine

SPM 962

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (8)

Unknown Facility

Chubu Region, Japan

Location

Unknown Facility

Chugoku 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

Interventions

rotigotine

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.

+81-3-6361-7366

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 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2012
• First Posted: June 29, 2012
• Study Start: October 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 19, 2014
• Results First Posted: March 19, 2014

Record last verified: 2014-02

Locations

JP (8)