Parkinson's DiseasePhase 3NCT01631825
A Long-Term Extension Trial From of SPM 962 in Advanced Parkinson's Disease Patients
A Phase 3 study testing SPM 962 in people with Parkinson's Disease, run by Otsuka Pharmaceutical Co., Ltd. at 8 sites in Japan.
Trial summary
To investigate the safety of once-daily repeated transdermal administration of SPM 962 within a dose range of 4.5 to 36.0 mg/day (54-week treatment period) in Parkinson's disease (PD) patients treated concomitantly with L-dopa in a multi-center, open-label uncontrolled study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- SPM 962
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 321 participants
- Where
- 8 sitesJapan
- Study dates
- Oct 2009to Jun 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject completed the preceding trial 243-08-001.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
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: 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
- To investigate the safety of once-daily repeated transdermal administration of SPM 962 within a dose range of 4.5 to 36.0 mg/day (54-week treatment period) in Parkinson's disease (PD) patients treated concomitantly with L-dopa in a multi-center, open-label uncontrolled study.
- To investigate efficacy of SPM 962 in an exploratory manner.
- Conditions
- Parkinson's Disease
- Being tested
- SPM 962
- 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
Also called rotigotine
SPM 962 transdermal patch once a daily up to 36.0 mg/day
| Study group | Role | What they receive |
|---|---|---|
| SPM 962 | Experimental | SPM 962 transdermal patch Receives: Drug: SPM 962 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
The safety of the long-term SPM 962 treatment was examined based on the incidence and severity of AEs, vital signs, and laboratory parameters.
AEs of special interest (1-3) are defined as below:
- sudden onset of sleep
- obsessive-compulsive disorder or impulse-control disorder
- hallucination, delusion
Application site reaction is scored as -, ±, +, ++, +++, or ++++. More + indicates a greater severity of symptoms. The worst score obtained throughout the evaluation period was to be assessed.
Measured: Up to 55 weeks after dosing
Secondary outcomes (16)
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score
Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state).
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, Up to 54 weeks after dosing
UPDRS Part 2 Sum Score (Average of on State and Off State)
Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average of on state and off state).
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, up to 54 weeks after dosing
Absolute Time Spent "Off"
Mean number of hours in "off state" during a 24-hour period.
Measured: Baseline, up to 54 weeks after dosing
UPDRS Part 1 Sum Score
Mean change (LOCF) from baseline in UPDRS Part 1 sum score.
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, up to 54 weeks after dosing
UPDRS Part 2 Sum Score (On State)
Mean change (LOCF) from baseline in UPDRS Part 2 sum score (on state). A decrease in the scores means improvement.
Measured: Baseline, up to 54 weeks after dosing
UPDRS Part 2 Sum Score (Off State)
Mean change (LOCF) from baseline in UPDRS Part 2 sum score (off state). A decrease in the scores means improvement.
Measured: Baseline, up to 54 weeks after dosing
UPDRS Part 4 Sum Score
Mean change (LOCF) from baseline in UPDRS Part 4 sum score.
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, 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
Mean change (LOCF) from baseline in 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.
A decrease in the scores means improvement.
Measured: Baseline, up to 54 weeks after dosing
The Modified Hoehn & Yahr Severity of Illness
Change (LOCF) from baseline in the Modified Hoehn \& Yahr Severity of Illness. 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.
The data at week 52 is shown.
Measured: Baseline, up to 54 weeks after dosing.
Each Item of UPDRS Part 1
The percentage of subjects with elevated scores for each item of UPDRS Part 1. The data at week 52 is shown.
Measured: Baseline, up to 54 weeks after dosing.
Each Item of UPDRS Part 2 (on State)
The percentage of subjects with elevated scores for each item of UPDRS Part 2 (on state). The data at week 52 is shown.
Measured: Baseline, up to 54 weeks after dosing.
Each Item of UPDRS Part 2 (Off State)
The percentage of subjects with elevated scores for each item of UPDRS Part 2 (off state). The data at week 52 is shown.
Measured: Baseline, up to 54 weeks after dosing.
Each Item of UPDRS Part 2 (Average of on State and Off State)
The percentage of subjects with elevated scores for each item of UPDRS Part 2 (average of on state and off state). The data at week 52 is shown.
Measured: 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)
Mean change (LOCF) from baseline in total of UPDRS Part 2 sum score (average of on state and off state) and UPDRS Part 3 sum score (on state).
A decrease in the scores means improvement.
Measured: Baseline, up to 54 weeks after dosing
Each Item of UPDRS Part 3 (on State)
The percentage of subjects with elevated scores for each item of UPDRS Part 3 (on state). The data at week 52 is shown.
Measured: Baseline, up to 54 weeks after dosing.
Each Item of UPDRS Part 4
The percentage of subjects with elevated scores for each item of UPDRS Part 4. The data at week 52 is shown.
Measured: Baseline, up to 54 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 posted29 Jun 2012 (estimated)
- Study startOct 2009
- Primary completionJun 2012
- Study completionJun 2012
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 321 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
- NCT01631825
- Sponsor's protocol ID
- 243-08-002
- Status last verified
- Feb 2014
- First submitted
- 25 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
- 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
- ClinicalTrials.gov ID
- NCT01631825
- Acronym / sponsor ID
- 243-08-002
- Conditions
- Parkinson's Disease
- Keywords
- SPM 962, rotigotine, Parkinson's disease, concomitant use of L-dopa
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 29 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.
- To investigate the safety of once-daily repeated transdermal administration of SPM 962 within a dose range of 4.5 to 36.0 mg/day (54-week treatment period) in Parkinson's disease (PD) patients treated concomitantly with L-dopa in a multi-center, open-label uncontrolled study.
- To investigate efficacy of SPM 962 in an exploratory manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPM 962 | Experimental | Drug: SPM 962SPM 962 transdermal patch |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subject completed the preceding trial 243-08-001.
Key exclusion criteria (16 listed)
- 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.
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 962Also: rotigotineSPM 962 transdermal patch once a daily up to 36.0 mg/day | Drug | SPM 962 |
Primary outcome
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
Time frame: Up to 55 weeks after dosing
The safety of the long-term SPM 962 treatment was examined based on the incidence and severity of AEs, vital signs, and laboratory parameters. AEs of special interest (1-3) are defined as below: 1. sudden onset of sleep 2. obsessive-compulsive disorder or impulse-control disorder 3. hallucination, delusion Application site reaction is scored as -, ±, +, ++, +++, or ++++. More + indicates a greater severity of symptoms. The worst score obtained throughout the evaluation period was to be assessed.
16 secondary outcomes
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 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
Absolute Time Spent "Off"
Time frame: Baseline, up to 54 weeks after dosing
UPDRS Part 1 Sum Score
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
UPDRS Part 2 Sum Score (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
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
The Modified Hoehn & Yahr Severity of Illness
Time frame: Baseline, up to 54 weeks after dosing.
Each Item of UPDRS Part 1
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.
Each Item of UPDRS Part 2 (Off State)
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.
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
Each Item of UPDRS Part 3 (on 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.
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.
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 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 1 inclusion and 16 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 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. 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 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?
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters (time frame: Up to 55 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.