A Long-Term Extension Trial From Phase II/III of SPM 962 in Early Parkinson's Disease Patients

NCT01628965 | Completed Phase 2 Results

• 1 other identifier: 243-07-002
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 7

Brief Summary

Safety of SPM 962 in a once-daily repeated long-term treatment in Parkinson's disease patients who are not concomitantly treated with L-dopa will be investigated with a doses.

Conditions

Parkinson's Disease

Keywords

SPM 962; rotigotine; Parkinson's disease; monotherapy

Outcome Measures

Primary Outcomes (2)

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

  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

  Up to 55 weeks after dosing

• Skin Irritation Score of the Application Site

  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

  Up to 55 weeks after dosing

Secondary Outcomes (1)

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

  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 243-07-001 (NCT00537485)

You may not qualify if:

• 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.

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

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 2
• 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 27, 2012
• Study Start: January 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 19, 2014
• Results First Posted: March 19, 2014

Record last verified: 2014-02

Locations

JP (7)