Early Parkinson's DiseasePhase 2/3NCT00537485
A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients
A Phase 2/3 study testing SPM 962 in people with Early Parkinson's Disease, run by Otsuka Pharmaceutical Co., Ltd. at 6 sites in Japan.
Trial summary
To investigate superiority of SPM 962 over placebo in early Parkinson's disease patients in a multi-center, placebo-controlled, double-blind study following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg (12-week dose titration/maintenance period) Read more about this study
- Who is it for?
- Ages 30 to 79 years
- Conditions the study is for
- Early Parkinson's Disease
- What is being tested?
- SPM 962
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 6 sitesJapan
- Study dates
- Sep 2007to Dec 2009
- Phase
- Phase 2/3
- 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 years < > 80 years at the time of informed consent
- Hoehn \& Yahr stage 1- 3
- Total of each sum score of UPDRS Part 2 and 3 is over 10 at screening test
Who cannot join
- Subject has previously participated in a trial with SPM 962
- Subject is on L-dopa treatment for total of over 6 months at the time of informed consent
- Subject has psychiatric symptoms, e.g. confusion, hallucination, delusion, excitation, delirium, abnormal behavior at screening test and baseline
- Subject has orthostatic hypotension
- Subject has a history of epilepsy, convulsion and other
- Subject has a complication of serious cardiac disorder/arrhythmia or has the history
Show all 20Show fewer
- Subject has arrhythmia and treated with class 1a anti-arrhythmic drugs (e.g. quinidine, procainamide etc.) or class 3 anti-arrhythmic drugs (e.g. amiodarone, sotalol etc.)
- Subject has serious ECG abnormal at screening i.e.; 1) Subject has more than 450 msec of QTc values both in two measurements at screening test 2) Subject has more than 470 msec for females and more than 450 msec for males of mean QTc values of two measurements at baseline
- Subject has congenital long QT syndrome
- Subject has serum potassium of less than 3.5 mEq/L at screening test.
- Subject has total bilirubin of 3.0 mg/dL and above or AST(GOT), ALT(GPT) greater than 2.5 times (or 100 IU/L and above) of the clinical laboratory's upper limit of the reference range at screening test
- Subject has 30 mg/dL and above of BUN or 2.0 mg/dL and above of serum creatinine at screening test
- Subject has a history of allergy to topical medicine, e.g. transdermal patch
- Subject is pregnant, nursing, or is child bearing potential while 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
- Subject is unable to give consent
- Subject is participating in another trial of an investigational drug or done so within 12 weeks prior to the initial treatment
- Investigator judges that subject is inappropriate as a study subject with other reasons
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
Study site
Chubu Region
Study site
Hokkaido Region
Study site
Kanto Region
Study site
Kinki Region
Study site
Kyushu Region
Study site
Tohoku Region
About this study
Official title: A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients With Non-concomitant Treatment of L-dopa
To investigate superiority of SPM 962 over placebo in early Parkinson's disease patients in a multi-center, placebo-controlled, double-blind study following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg (12-week dose titration/maintenance period)
- Conditions
- Early Parkinson's Disease
- Being tested
- SPM 962, placebo
- Keywords
- SPM 962, rotigotine, Parkinson's disease, monotherapy
- 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
transdermal application, 1 time per day
placeboDrug
transdermal application, 1 time per day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: SPM 962 |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to the End of Maintenance Period in Total of Each Sum Score of UPDRS Part 2 and Part 3
Mean change (LOCF) from baseline to the end of maintenance period in total of each sum score of UPDRS Part 2 and Part 3.
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 2 assesses 13 items and 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, end of maintenance period
Secondary outcomes (9)
Efficacy Rate in Total of Each Sum Score of UPDRS Part 2 and Part 3
Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in total of each sum score of UPDRS Part 2 and Part 3 at the end of maintenance period
Measured: baseline, end of maintenance period
Mean Change in UPDRS Part 2 Sum Score
Mean change (LOCF) from baseline in UPDRS Part 2 sum score at every two weeks after dosing.
UPDRS sub-scale Part 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, every two weeks
Efficacy Rate in UPDRS Part 2 Sum Score
Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score at every two weeks after dosing.
Measured: Baseline, every two weeks
UPDRS Part 3 Sum Score
Mean change (LOCF) from baseline in UPDRS Part 3 sum score at every two weeks after dosing.
UPDRS sub-scale 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, every two weeks
Efficacy Rate in UPDRS Part 3 Sum Score
Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score at every two weeks after dosing.
Measured: Baseline, every two weeks
UPDRS Part 1 Sum Score
MMean change (LOCF) from baseline in UPDRS Part 1 sum score at every two weeks after dosing.
UPDRS sub-scale Part 1 assesses 4 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, every two weeks
UPDRS Part 4 Sum Score
Mean change (LOCF) from baseline in UPDRS Part 4 sum score at every two weeks after dosing.
UPDRS sub-scale Part 4 assesses 11 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, every two weeks
Total of Each Sum Score of UPDRS Part 1, 2, 3, and 4
Mean change (LOCF) from baseline to the end of maintenance period in total of each sum score of UPDRS Part 1, 2, 3 and 4.
UPDRS sub-scale Part 1, 2, 3, and 4 assess 4, 13, 14, and 11 items respectively. 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, every two weeks
The Modified Hoehn and Yahr Stage
Mean change (LOCF) from baseline in the Modified Hoehn and Yahr Severity of Illness at the end of maintenance period. The Modified Hoehn and Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease without impairment of balance; 2.5, Mild bilateral disease with recovery on pull test; 3, Mild to moderate bilateral disease, some postural instability, physically independent 4, Severe disability, still able to walk or stand unassisted; and 5, Wheelchair bound or bedridden unless aided.
Measured: Baseline, end of maintenance period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2009
- Study completionDec 2009
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 Early 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katsuhisa Saito, Study director, New Product Evaluation and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537485
- Sponsor's protocol ID
- 243-07-001
- Status last verified
- Feb 2014
- First submitted
- 27 Sep 2007
- Last updated
- 19 Mar 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 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients With Non-concomitant Treatment of L-dopa
- ClinicalTrials.gov ID
- NCT00537485
- Acronym / sponsor ID
- 243-07-001
- Conditions
- Early Parkinson's Disease
- Keywords
- SPM 962, rotigotine, Parkinson's disease, monotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 1 Oct 2007 (estimated)
- Results
- Posted 19 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate superiority of SPM 962 over placebo in early Parkinson's disease patients in a multi-center, placebo-controlled, double-blind study following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg (12-week dose titration/maintenance period)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SPM 962 |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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 years < > 80 years at the time of informed consent
- Hoehn \& Yahr stage 1- 3
- Total of each sum score of UPDRS Part 2 and 3 is over 10 at screening test
Key exclusion criteria (20 listed)
- Subject has previously participated in a trial with SPM 962
- Subject is on L-dopa treatment for total of over 6 months at the time of informed consent
- Subject has psychiatric symptoms, e.g. confusion, hallucination, delusion, excitation, delirium, abnormal behavior at screening test and baseline
- Subject has orthostatic hypotension
- Subject has a history of epilepsy, convulsion and other
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 962transdermal application, 1 time per day | Drug | 1 |
| placebotransdermal application, 1 time per day | Drug | 2 |
Primary outcome
Change From Baseline to the End of Maintenance Period in Total of Each Sum Score of UPDRS Part 2 and Part 3
Time frame: baseline, end of maintenance period
Mean change (LOCF) from baseline to the end of maintenance period in total of each sum score of UPDRS Part 2 and Part 3. 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 2 assesses 13 items and 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.
9 secondary outcomes
Efficacy Rate in Total of Each Sum Score of UPDRS Part 2 and Part 3
Time frame: baseline, end of maintenance period
Mean Change in UPDRS Part 2 Sum Score
Time frame: Baseline, every two weeks
Efficacy Rate in UPDRS Part 2 Sum Score
Time frame: Baseline, every two weeks
UPDRS Part 3 Sum Score
Time frame: Baseline, every two weeks
Efficacy Rate in UPDRS Part 3 Sum Score
Time frame: Baseline, every two weeks
UPDRS Part 1 Sum Score
Time frame: Baseline, every two weeks
UPDRS Part 4 Sum Score
Time frame: Baseline, every two weeks
Total of Each Sum Score of UPDRS Part 1, 2, 3, and 4
Time frame: Baseline, every two weeks
The Modified Hoehn and Yahr Stage
Time frame: Baseline, end of maintenance period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 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.
Katsuhisa Saito study director
New Product Evaluation and Development
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SPM 962 in people with Early Parkinson's Disease, run by Otsuka Pharmaceutical Co., Ltd. at 6 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 4 inclusion and 20 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 19 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 19 Mar 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?
Change From Baseline to the End of Maintenance Period in Total of Each Sum Score of UPDRS Part 2 and Part 3 (time frame: baseline, end of maintenance period). 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 19 Mar 2014.