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Parkinson's DiseasePhase 2NCT01631812

A Long-Term Extension Trial From Late Phase II of 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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study is to investigate safety of SPM 962 in advanced PD patients in a multi-center, open-label, non-controlled study following once-daily multiple transdermal doses of SPM962 within a range of 4.5 to 36.0 mg (maximum treatment period: 54 weeks). 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
130 participants
Where
7 sitesJapan
Study dates
Dec 2006to Feb 2010
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Subject completed the preceding trial 243-05-001.

Who cannot join

  • Subject discontinued from the preceding trial 243-05-001.
  • Subject had a serious adverse event which association with the investigational drug was not ruled out during trial 243-05-001.
  • Subject has a persistent serious adverse event at the baseline, which was observed and association with the investigational drug was ruled out during trial 243-05-001.
  • Subject had persistent hallucination or delusion during trial 243-05-001.
  • Subject has psychiatric conditions such as confusion, excitation, delirium, abnormal behaviour at the baseline.
  • Subject has orthostatic hypotension at baseline.
Show all 19Show fewer
  • Subject has a history of epilepsy, convulsion etc. during trial 243-05-001.
  • Subject has a complication of serious cardiac disorder.
  • Subject has arrhythmia and need to be treated with class 1a antiarrhythmic drugs (e.g. quinidine, procainamide etc.) or class 3 antiarrhythmic drugs (e.g. amiodarone, sotalol etc.).
  • 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 243-05-001 and has a QTc-interval > 470 msec in female or > 450 msec in male at the baseline.
  • Subject had hypokalaemia in 243-05-001 study and not yet recovered.
  • 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 243-05-001.
  • Subject has BUN >= 25 mg/dL or serum creatinine >= 2.0 mg/dl at the end of the taper period in trial 243-05-001.
  • Subject has a history of allergic reaction to topical agents such as transdermal patch. Subject showed serious or extensive application site reactions beyond the application site in the 243-05-001 study.
  • Subject who plans pregnancy during the trial.
  • Subject has dementia.
  • 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

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

Other trials in Japan

About this study

Official title: An Open-label Long-term Extension Trial From Late Phase II of SPM962 (243-05-001) in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa

The primary objective of this study is to investigate safety of SPM 962 in advanced PD patients in a multi-center, open-label, non-controlled study following once-daily multiple transdermal doses of SPM962 within a range of 4.5 to 36.0 mg (maximum treatment period: 54 weeks). Efficacy is also to be exploratory investigated.

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

    SPM 962 transdermal patch once a daily up to 36.0 mg/day

Study groups in NCT01631812
Study groupRoleWhat they receive
SPM 962ExperimentalNot described
Receives: Drug: SPM 962

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters.

    Incidence and severity of adverse events, vital signs, and laboratory parameters after dosing.

    *decrease in difference between supine and standing systolic blood pressure

    Measured: Up to 55 weeks after dosing

  2. Skin Irritation Score of the Application Site

    Skin irritation score of the application site were evaluated according to the criteria below. The worst score throughout the treatment period was used in the analysis.

    -: no reaction, ±: mild erythema, +: erythema, ++: erythema and Oedema, +++: erythema and oedema and rash papular, or serous papule, or vesicles, ++++: bullosum

    Measured: Up to 55 weeks after dosing

Secondary outcomes (3)

  1. Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score

    Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) up to 54 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, Up to 54 weeks after dosing

  2. UPDRS Part 2 Sum Score

    Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average scores of on state and off state) up to 54 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, Up to 54 weeks after dosing

  3. Absolute Time Spent "Off"

    Mean number of hours in "off state" during a 24-hour period.

    Measured: 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.

  1. First posted29 Jun 2012 (estimated)
  2. Study startDec 2006
  3. Primary completionFeb 2010
  4. Study completionFeb 2010

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01631812
Sponsor's protocol ID
243-06-001
Status last verified
Feb 2014
First submitted
25 Jun 2012
Last updated
19 Mar 2014
Data monitoring committee
No

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 1 inclusion and 19 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. 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?

Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters. (time frame: Up to 55 weeks after dosing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01631812.

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.

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