Parkinson's DiseasePhase 3NCT01628926
A Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients
A Phase 3 study testing SPM 962 and Ropinirole in people with Parkinson's Disease, run by Otsuka Pharmaceutical Co., Ltd. at 8 sites in Japan.
Trial summary
To demonstrate the non-inferiority of SPM 962 to ropinirole in terms of efficacy in order to confirm clinical value of SPM 962. To demonstrate the superiority of SPM 962 to placebo in terms of efficacy. To investigate the tolerability and safety of SPM 962 up to 36.0 mg/day. Read more about this study
- Who is it for?
- Ages 30 to 79 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- SPM 962 and Ropinirole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 8 sitesJapan
- Study dates
- Jun 2009to May 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject diagnosed as having Parkinson's disease in accordance with "Diagnostic Criteria established by the Research Committee of MHLW-specified Intractable Neurodegenerative Diseases (1995)".
- Subject is 30 and more and less than 80 years of age at the time of informed consent.
- Hoehn \& Yahr stage 2-4 (on time).
- Total UPDRS Part 3 score is over 10 at screening test (on time).
- Subject is on a stable dose of L-dopa with no change in daily dose or dosing regimen for at least 28 days prior to the initial treatment of SPM 962.
- Subject has any of the following problematic symptoms; 1) Wearing off phenomenon (including frozen gait at off time and dystonia at off time) 2) On and off phenomenon 3) Delayed-on and/or No-on phenomenon 4) Dyskinesia 5) Not well controlled with L-dopa.
Who cannot join
- Subject who has previously participated in a clinical trial of SPM962 and taken the investigational product (IP).
- Subject has psychiatric symptoms, e.g. confusion, hallucination, delusion, excitation, delirium, abnormal behavior at screening test or baseline.
- Subject whose SBP declines by at least 30 mmHg from supine to standing position based on the orthostatic hypotension assessment, or subject who develops orthostatic hypotension at baseline.
- Subject has a history of epilepsy, convulsion and other.
- Subject who has complications or a history of serious cardiac diseases or arrhythmia (eg, congestive heart failure of class 3 or 4 in the NYHA classification, second or third degree atrioventricular block, complete left bundle branch block, sick sinus syndrome, ventricular fibrillation, myocardial infarction within 12 months prior to the screening test, or a complication of angina pectoris).
- Subjects has QTc-interval >450 msec twice at screening. Subject has a the average QTc-interval from two ECGs >450 msec in males and >470 msec in females at baseline.
Show all 21Show fewer
- Subject has congenital long QT syndrome.
- Subject whose serum potassium level is < 3.5mEq/L at the screening test.
- 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 screening test, or suffers complications of active phase of chronic hepatitis or liver cirrhosis.
- Subject has BUN >= 30 mg/dL or serum creatinine >= 2.0 mg/dl at screening test.
- Subject has a history of allergic reaction to topical agents such as transdermal patch.
- Subject has a history of known intolerance/hypersensitivity to ropinirole and/or adverse drug reactions that prevent subject from receiving treatment.
- Subject is pregnant or nursing or woman who plans pregnancy during the trial.
- Subject is receiving therapy with prohibited drug specified in the study protocol.
- Subject has a history of pallidotomy, thalamotomy, deep brain stimulation or fetal tissue transplant.
- Subject has dementia, including DLB and PDD (MMSE score <= 24 at screening).
- Subject who has a complication or history of malignant neoplastic disease, or received treatment for the disease within 12 months prior to the screening test.
- Subject is unable to give consent.
- Subject who is unable to properly record information in a diary.
- Subject is participating in another trial of IPs or received other IPs within 12 weeks prior to commencement of study treatment.
- Investigator judges that subject is inappropriate as a study subject with other reasons.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Study site
Chubu Region
Study site
Chugoku Region
Study site
Hokkaido Region
Study site
Kanto Region
Study site
Kinki Region
Study site
Kyushu Region
Study site
Shikoku Region
Study site
Tohoku Region
About this study
Official title: A Double-Blind, 3-Arm, Parallel Group, Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa
- To demonstrate the non-inferiority of SPM 962 to ropinirole in terms of efficacy in order to confirm clinical value of SPM 962.
- To demonstrate the superiority of SPM 962 to placebo in terms of efficacy.
- To investigate the tolerability and safety of SPM 962 up to 36.0 mg/day.
- Conditions
- Parkinson's Disease
- Being tested
- SPM 962, Ropinirole, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPM 962Drug
SPM 962 transdermal patch once a daily up to 36.0 mg/day
RopiniroleDrug
Ropinirole oral administration TID up to 15.0 mg/day
PlaceboDrug
SPM962-placebo patch and Ropinirole-placebo tab
| Study group | Role | What they receive |
|---|---|---|
| SPM 962 | Experimental | SPM 962 transdermal patch Receives: Drug: SPM 962 |
| Ropinirole | Active comparator | Ropinirole tablet Receives: Drug: Ropinirole |
| Placebo | Placebo comparator | SPM962 placebo patch and Ropinirole placebo tab Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson's Disease Rating Score (UPDRS) Part 3 Sum Score
Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) at 16 weeks after dosing.
UPDRS 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 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.
Measured: baseline, 16 weeks after dosing
Secondary outcomes (13)
UPDRS Part 3 Sum Score
Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) at 8 and 10 weeks after dosing.
UPDRS 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.
Measured: baseline, 8 and 10 weeks after dosing
UPDRS Part 2 Sum Score
Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average scores of on state and off state) at 16 weeks after dosing.
UPDRS 2 assesses 13 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.
Measured: Baseline, 16 weeks after dosing
Off Time
Mean change (LOCF) from baseline in off time at 16 weeks after dosing. Off-time is a state where L-Dopa becomes ineffective. Off-time was measured by patient diary in hours/day.
Measured: Baseline, 16 weeks after dosing
Parkinson's Disease Sleep Scale-2 (PDSS-2)
Mean change (LOCF) from baseline in PDSS-2 sum score at 16 weeks after dosing. PDSS-2 is a scale for assessing sleep disorders in Parkinson's disease. PDSS consists of 15 questions about sleep and nocturnal disturbances. The score of each question ranges from 0 (never) to 4 (very frequent). The sum of each question serves as the scale score. Thus a decrease in the scores means improvement.
Measured: Baseline, 16 weeks after dosing
On Time
Mean change (LOCF) from baseline in on time at 16 weeks after dosing. On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day.
Measured: Baseline, 16 weeks after dosing
On Time Without Dyskinesia Disturbing Daily Activities
Mean change (LOCF) from baseline in on time without dyskinesia disturbing daily activities at 16 weeks after dosing.
On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day.
Measured: Baseline, 16 weeks after dosing
On Time With Dyskinesia Disturbing Daily Activities
Mean change (LOCF) from baseline in on time with dyskinesia disturbing daily activities at 16 weeks after dosing (rate against on time).
Measured: Baseline, 16 weeks after dosing
Effective Rate in UPDRS Part 3 Sum Score
Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 3 sum score (on state) at 16 weeks after dosing.
Measured: Baseline, 16 weeks after dosing
Effective Rate in UPDRS Part 2 Sum Score
Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score (average scores of on state and off state) at 16 weeks after dosing.
Measured: Baseline, 16 weeks after dosing
Effective Rate in Off Time
Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in off time at 16 weeks after dosing.
On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day.
Measured: Baseline, 16 weeks after dosing
Clinical Global Impression (CGI)
Change (LOCF) from baseline in CGI score. CGI improvement is a clinician-reported scale for assessing how much the patient's illness has improved or worsened from baseline.
The scale scoring criteria are 1: very much improved, 2: much improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: much worse, 7: very much worse. A decrease in the scores means improvement.
Measured: Baseline, 16 weeks after dosing
Dystonia (at an Early Hour)
Change (LOCF) from baseline in occurrence of Dystonia (at an early hour).
Measured: Baseline, 16 weeks after dosing
Dystonia (in the Daytime)
Change (LOCF) from baseline in occurrence of Dystonia (in the daytime).
Measured: Baseline, 16 weeks after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startJun 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyoji Imaoka, Mr, Study director, Otsuka Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628926
- Sponsor's protocol ID
- 243-08-001
- Other IDs
- JapicCTI-090888
- Status last verified
- Apr 2014
- First submitted
- 24 Jun 2012
- Last updated
- 23 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, 3-Arm, Parallel Group, Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa
- ClinicalTrials.gov ID
- NCT01628926
- Acronym / sponsor ID
- 243-08-001
- Conditions
- Parkinson's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 27 Jun 2012 (estimated)
- Results
- Posted 23 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To demonstrate the non-inferiority of SPM 962 to ropinirole in terms of efficacy in order to confirm clinical value of SPM 962.
- To demonstrate the superiority of SPM 962 to placebo in terms of efficacy.
- To investigate the tolerability and safety of SPM 962 up to 36.0 mg/day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SPM 962 | Experimental | Drug: SPM 962SPM 962 transdermal patch |
| Ropinirole | Active comparator | Drug: RopiniroleRopinirole tablet |
| Placebo | Placebo comparator | Drug: PlaceboSPM962 placebo patch and Ropinirole placebo tab |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject diagnosed as having Parkinson's disease in accordance with "Diagnostic Criteria established by the Research Committee of MHLW-specified Intractable Neurodegenerative Diseases (1995)".
- Subject is 30 and more and less than 80 years of age at the time of informed consent.
- Hoehn \& Yahr stage 2-4 (on time).
- Total UPDRS Part 3 score is over 10 at screening test (on time).
- Subject is on a stable dose of L-dopa with no change in daily dose or dosing regimen for at least 28 days prior to the initial treatment of SPM 962.
Key exclusion criteria (21 listed)
- Subject who has previously participated in a clinical trial of SPM962 and taken the investigational product (IP).
- Subject has psychiatric symptoms, e.g. confusion, hallucination, delusion, excitation, delirium, abnormal behavior at screening test or baseline.
- Subject whose SBP declines by at least 30 mmHg from supine to standing position based on the orthostatic hypotension assessment, or subject who develops orthostatic hypotension at baseline.
- Subject has a history of epilepsy, convulsion and other.
- Subject who has complications or a history of serious cardiac diseases or arrhythmia (eg, congestive heart failure of class 3 or 4 in the NYHA classification, second or third degree atrioventricular block, complete left bundle branch block, sick sinus syndrome, ventricular fibrillation, myocardial infarction within 12 months prior to the screening test, or a complication of angina pectoris).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPM 962SPM 962 transdermal patch once a daily up to 36.0 mg/day | Drug | SPM 962 |
| RopiniroleRopinirole oral administration TID up to 15.0 mg/day | Drug | Ropinirole |
| PlaceboSPM962-placebo patch and Ropinirole-placebo tab | Drug | Placebo |
Primary outcome
Unified Parkinson's Disease Rating Score (UPDRS) Part 3 Sum Score
Time frame: baseline, 16 weeks after dosing
Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) at 16 weeks after dosing. UPDRS 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 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.
13 secondary outcomes
UPDRS Part 3 Sum Score
Time frame: baseline, 8 and 10 weeks after dosing
UPDRS Part 2 Sum Score
Time frame: Baseline, 16 weeks after dosing
Off Time
Time frame: Baseline, 16 weeks after dosing
Parkinson's Disease Sleep Scale-2 (PDSS-2)
Time frame: Baseline, 16 weeks after dosing
On Time
Time frame: Baseline, 16 weeks after dosing
On Time Without Dyskinesia Disturbing Daily Activities
Time frame: Baseline, 16 weeks after dosing
On Time With Dyskinesia Disturbing Daily Activities
Time frame: Baseline, 16 weeks after dosing
Effective Rate in UPDRS Part 3 Sum Score
Time frame: Baseline, 16 weeks after dosing
Effective Rate in UPDRS Part 2 Sum Score
Time frame: Baseline, 16 weeks after dosing
Effective Rate in Off Time
Time frame: Baseline, 16 weeks after dosing
Clinical Global Impression (CGI)
Time frame: Baseline, 16 weeks after dosing
Dystonia (at an Early Hour)
Time frame: Baseline, 16 weeks after dosing
Dystonia (in the Daytime)
Time frame: Baseline, 16 weeks after dosing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyoji Imaoka, Mr study director
Otsuka Pharmaceutical Co., Ltd.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SPM 962 and Ropinirole in people with Parkinson's Disease, run by Otsuka Pharmaceutical Co., Ltd. at 8 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unified Parkinson's Disease Rating Score (UPDRS) Part 3 Sum Score (time frame: baseline, 16 weeks after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2014.