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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01631825
• Date of registration: 25/06/2012
• Prospective Registration: No
• Primary sponsor: Otsuka Pharmaceutical Co., Ltd.
• Public title: A Long-Term Extension Trial From of SPM 962 in Advanced Parkinson's Disease Patients
• Scientific title: An Open-label Long-term Extension Trial From Phase III of SPM962 (243-08-002) in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa
• Date of first enrolment: October 2009
• Target sample size: 321
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01631825
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Japan

Contacts

• Name: Kyoji Imaoka, Mr
• Affiliation: Otsuka Pharmaceutical Co., Ltd.

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: SPM 962

Primary Outcome(s)

Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters [Time Frame: Up to 55 weeks after dosing]

Secondary Outcome(s)

Each Item of UPDRS Part 3 (on State) [Time Frame: Baseline, up to 54 weeks after dosing.]

The Modified Hoehn & Yahr Severity of Illness [Time Frame: Baseline, up to 54 weeks after dosing.]

Total of UPDRS Part 2 Sum Score (Average of on State and Off State) and UPDRS Part 3 Sum Score (on State) [Time Frame: Baseline, up to 54 weeks after dosing]

UPDRS Part 1 Sum Score [Time Frame: Baseline, up to 54 weeks after dosing]

Each Item of UPDRS Part 1 [Time Frame: Baseline, up to 54 weeks after dosing.]

Total of UPDRS Part 1 Sum Score, UPDRS Part 2 Sum Score (Average of on State and Off State), UPDRS Part 3 Sum Score (on State), and UPDRS Part 4 Sum Score [Time Frame: Baseline, up to 54 weeks after dosing]

UPDRS Part 2 Sum Score (Average of on State and Off State) [Time Frame: Baseline, up to 54 weeks after dosing]

UPDRS Part 4 Sum Score [Time Frame: Baseline, up to 54 weeks after dosing]

Each Item of UPDRS Part 2 (Average of on State and Off State) [Time Frame: Baseline, up to 54 weeks after dosing.]

Each Item of UPDRS Part 4 [Time Frame: Baseline, up to 54 weeks after dosing.]

Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score [Time Frame: Baseline, Up to 54 weeks after dosing]

Each Item of UPDRS Part 2 (on State) [Time Frame: Baseline, up to 54 weeks after dosing.]

UPDRS Part 2 Sum Score (Off State) [Time Frame: Baseline, up to 54 weeks after dosing]

UPDRS Part 2 Sum Score (On State) [Time Frame: Baseline, up to 54 weeks after dosing]

Absolute Time Spent "Off" [Time Frame: Baseline, up to 54 weeks after dosing]

Each Item of UPDRS Part 2 (Off State) [Time Frame: Baseline, up to 54 weeks after dosing.]

Secondary ID(s)

243-08-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/03/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01631825