Parkinson's DiseasePhase 2NCT01628848
A Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients
A Phase 2 study testing SPM 962 in people with Parkinson's Disease, run by Otsuka Pharmaceutical Co., Ltd. at 7 sites in Japan.
Trial summary
The primary objective of this study is to investigate efficacy and safety of SPM 962 in advanced Parkinson's Disease (PD) patients in a multi-center, placebo-controlled study following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg (12 weeks of dose titration/maintenance period). 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 7 sitesJapan
- Study dates
- Aug 2006to Apr 2008
- Phase
- Phase 2
- 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 2) On and off phenomenon 3) Delayed-on and/or No-on phenomenon 4) Not well controlled with L-dopa due to adverse effect 5) Weakening of L-dopa efficacy.
Who cannot join
- Subject has previously participated in a trial with SPM 962.
- Subject is on other dopamine agonist treatment within 28 days prior to the initial treatment.
- Subject has psychiatric symptoms, e.g. confusion, hallucination, delusion, excitation, delirium, abnormal behavior at screening test or baseline.
- Subject has orthostatic hypotension.
- Subject has a history of epilepsy, convulsion and other.
- Subject has a complication of serious cardiac disorder or has the history.
Show all 20Show fewer
- Subject has arrhythmia and treated with class 1a antiarrhythmic drugs (e.g. quinidine, procainamide etc.) or class 3 antiarrhythmic drugs (e.g. amiodarone, sotalol etc.).
- At screening and baseline, subject develops serious ECG abnormality. 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.
- Subject has congenital long QT syndrome.
- Subject has hypokalaemia.
- 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.
- Subject has BUN >= 25 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 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.
- Subject is unable to give consent.
- Subject is participating in another trial of an investigational drug or done so within 24 weeks prior to the initial treatment.
- Investigator judges that subject is inappropriate as a study subject with other reasons.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Study site
Chubu 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 Placebo-controlled Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa
The primary objective of this study is to investigate efficacy and safety of SPM 962 in advanced Parkinson's Disease (PD) patients in a multi-center, placebo-controlled study following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg (12 weeks of dose titration/maintenance period). Recommended maintenance dose range is also to be investigated with distribution of the maintenance dose and accumulated response rate of efficacy.
- Conditions
- Parkinson's Disease
- Being tested
- SPM 962, Placebo
- Keywords
- SPM 962, rotigotine, Parkinson's disease, concomitant use of L-dopa
- 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
PlaceboDrug
Placebo transdermal patch
| Study group | Role | What they receive |
|---|---|---|
| SPM 962 | Experimental | SPM 962 transdermal patch Receives: Drug: SPM 962 |
| Placebo | Placebo comparator | Placebo transdermal patch 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 Scale (UPDRS) Part 3 Sum Score
Mean change (LOCF) from baseline in UPDRS Part 3 sum score at 12 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, 12 weeks after dosing
Secondary outcomes (11)
UPDRS Part 2 Sum Score (Average Score of on State and Off State)
Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average scores of on state and off state) at 12 weeks after dosing.
Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average score of on state and off state) at 12 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, 12 weeks after dosing
Off Time
Mean change (LOCF) from baseline in off time at 12 weeks after dosing.
Measured: baseline, 12 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 at 12 weeks after dosing.
Measured: Baseline, 12 weeks after dosing
UPDRS Part 1 Sum Score
Mean change (LOCF) from baseline in UPDRS Part 1 sum score at 12 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, 12 weeks after dosing
Effective Rate in Off Time
Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in off time at 12 weeks after dosing.
Measured: Baseline, 12 weeks after dosing.
UPDRS Part 2 Sum Score (on State)
Mean change (LOCF) from baseline in UPDRS Part 2 sum score (on state) at 12 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, 12 weeks after dosing
UPDRS Part 2 Sum Score (Off State)
Mean change (LOCF) from baseline in UPDRS Part 2 sum score (off state) at 12 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, 12 weeks after dosing
UPDRS Part 4 Sum Score
Mean change (LOCF) from baseline in UPDRS Part 4 sum score at 12 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, 12 weeks after dosing
Total of UPDRS Part 2 Sum Score (Average Score of on State and Off State) and UPDRS Part 3 Sum Score
Mean change (LOCF) from baseline in total of UPDRS Part 2 sum score (average score of on state and off state), and UPDRS Part 3 sum score at 12 weeks after dosing.
UPDRS sub-scale 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, 12 weeks after dosing
Total of UPDRS Part 1 Sum Score, UPDRS Part 2 Sum Score (Average Score of on State and Off State), UPDRS Part 3 Sum Score, and UPDRS Part 4 Sum Score.
Mean change (LOCF) from baseline in total of UPDRS Part 1 sum score, UPDRS Part 2 sum score (average score of on state and off state), UPDRS Part 3 sum score, and UPDRS Part 4 sum score at 12 weeks after dosing.
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, 12 weeks after dosing
The Modified Hoehn & Yahr Severity of Illness
Mean change (LOCF) from baseline in the Modified Hoehn \& Yahr Severity of Illness at 12 weeks after dosing.
The Modified Hoehn \& 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, 12 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 startAug 2006
- Primary completionApr 2008
- Study completionApr 2008
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.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 174 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
- NCT01628848
- Sponsor's protocol ID
- 243-05-001
- Other IDs
- JapicCTI-060287
- Status last verified
- Feb 2014
- First submitted
- 24 Jun 2012
- 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 Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa
- ClinicalTrials.gov ID
- NCT01628848
- Acronym / sponsor ID
- 243-05-001
- Conditions
- Parkinson's Disease
- Keywords
- SPM 962, rotigotine, Parkinson's disease, concomitant use of L-dopa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 27 Jun 2012 (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.
The primary objective of this study is to investigate efficacy and safety of SPM 962 in advanced Parkinson's Disease (PD) patients in a multi-center, placebo-controlled study following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg (12 weeks of dose titration/maintenance period). Recommended maintenance dose range is also to be investigated with distribution of the maintenance dose and accumulated response rate of efficacy.
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 |
|---|---|---|
| SPM 962 | Experimental | Drug: SPM 962SPM 962 transdermal patch |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo transdermal patch |
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 (20 listed)
- Subject has previously participated in a trial with SPM 962.
- Subject is on other dopamine agonist treatment within 28 days prior to the initial treatment.
- Subject has psychiatric symptoms, e.g. confusion, hallucination, delusion, excitation, delirium, abnormal behavior at screening test or 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 962SPM 962 transdermal patch once a daily up to 36.0 mg/day | Drug | SPM 962 |
| PlaceboPlacebo transdermal patch | Drug | Placebo |
Primary outcome
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score
Time frame: baseline, 12 weeks after dosing
Mean change (LOCF) from baseline in UPDRS Part 3 sum score at 12 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.
11 secondary outcomes
UPDRS Part 2 Sum Score (Average Score of on State and Off State)
Time frame: baseline, 12 weeks after dosing
Off Time
Time frame: baseline, 12 weeks after dosing
Effective Rate in UPDRS Part 3 Sum Score
Time frame: Baseline, 12 weeks after dosing
UPDRS Part 1 Sum Score
Time frame: Baseline, 12 weeks after dosing
Effective Rate in Off Time
Time frame: Baseline, 12 weeks after dosing.
UPDRS Part 2 Sum Score (on State)
Time frame: Baseline, 12 weeks after dosing
UPDRS Part 2 Sum Score (Off State)
Time frame: Baseline, 12 weeks after dosing
UPDRS Part 4 Sum Score
Time frame: Baseline, 12 weeks after dosing
Total of UPDRS Part 2 Sum Score (Average Score of on State and Off State) and UPDRS Part 3 Sum Score
Time frame: Baseline, 12 weeks after dosing
Total of UPDRS Part 1 Sum Score, UPDRS Part 2 Sum Score (Average Score of on State and Off State), UPDRS Part 3 Sum Score, and UPDRS Part 4 Sum Score.
Time frame: Baseline, 12 weeks after dosing
The Modified Hoehn & Yahr Severity of Illness
Time frame: Baseline, 12 weeks after dosing
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.
Kyoji Imaoka, Mr study director
Otsuka Pharmaceutical Co., Ltd.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SPM 962 in people with Parkinson's Disease, run by Otsuka Pharmaceutical Co., Ltd. at 7 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 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 7 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score (time frame: baseline, 12 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 19 Mar 2014.