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Idiopathic Parkinson's DiseasePhase 3NCT01646255

Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease Patients

A Phase 3 study testing Rotigotine and L-dopa in people with Idiopathic Parkinson's Disease, run by UCB Pharma at 24 sites in China.

Completed

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

Official record
Search all trials

Trial summary

The primary objective of this study was to demonstrate that Rotigotine transdermal patch is efficacious in Chinese subjects with advanced-stage Idiopathic Parkinson's Disease as an adjuvant therapy. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Idiopathic Parkinson's Disease
What is being tested?
Rotigotine and L-dopa
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
346 participants
Where
24 sitesChina
Study dates
Jul 2012to Oct 2014
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • An Independent Ethics Committee (IEC)-approved written informed consent is signed and dated by the subject or by the legal representative
  • Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication application according to the judgment of the investigator
  • Subject has Idiopathic Parkinson's Disease of more than 3 years' duration, defined by the cardinal sign, Bradykinesia, plus the presence of at least 1 of the following: resting tremor, rigidity, or impairment of postural reflexes, and without any other known or suspected cause of Parkinsonism
  • The investigator must observe the subject in both the 'on' and 'off' state and determine that the subject is Hoehn \& Yahr stage 2 through 4 in both the 'on' and 'off' state
  • Subject is male or female and aged ≥30 years at Screening (Visit 1)
  • Subject has a Mini Mental State Examination (MMSE) score of ≥25 at Screening (Visit 1)
Show all 13Show fewer
  • Subject must be on a stable dose of L-dopa (either short-acting or sustained release [in combination with Benserazide or Carbidopa]) of at least 200 mg/day, administered in at least 2 intakes, for at least 28 days prior to Baseline (Visit 2)
  • Subject is not adequately controlled on a L-dopa dose (in combination with Benserazide or Carbidopa) which was judged by the treating physician to be optimal
  • Subject must be willing and able to accurately complete a subject diary on designated days (with assistance from caregivers, if required), recording periods when they are 'on without troublesome Dyskinesia', 'on with troublesome Dyskinesia', 'off', and sleeping
  • As part of the Screening (pretreatment) assessments, the subject must complete a diary over a period of 6 days, with 4 of the 6 diaries being 'valid' as determined by the investigator (see Section 9.1.1)
  • It must be clear to the investigator that the subject is able to differentiate between the 'on' and 'off' state and the 'valid' diaries confirm that the subject has an average of ≥2.5 h/day spent in the 'off' state
  • If the subject is receiving an Anticholinergic agent (eg, Benztropine, Trihexyphenidyl, Parsitan, Procyclidine, Biperiden), a monoamine oxidase (MAO)-B inhibitor (eg, Selegiline), and/or an N-methyl-d-aspartate (NMDA) antagonist (eg, Amantadine), he/she must have been on a stable dose for at least 28 days prior to Baseline (Visit 2) and be maintained on that dose for the duration of the study
  • Subject must be on a stable dose of all anti-Parkinsonian medications for at least 20 days prior to completing the 6 Baseline diaries

Who cannot join

  • Subject has previously participated in this study or subject has previously received the study medication under investigation in this study
  • Subject is participating in another study of an investigational drug or has done so within 28 days prior to the Baseline Visit (Visit 2)
  • Subject has a history of significant skin hypersensitivity to adhesive or other transdermal preparations, or recent unresolved contact dermatitis
  • Subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening (Visit 1)
  • Subject has atypical Parkinson's syndrome(s) due to drugs (eg, Metoclopramide, Flunarizine), Metabolic Neurogenetic Disorders (eg, Wilson's Disease), Encephalitis, Cerebrovascular Disease, or Degenerative Disease (eg, Progressive Supranuclear Palsy)
  • Subject has a history of Pallidotomy, Thalamotomy, deep brain stimulation, or fetal tissue transplant
Show all 20Show fewer
  • Subject has dementia, active psychosis or hallucinations, or severe depression
  • Subject is receiving therapy with a Dopamine agonist either concurrently or has done so within 28 days prior to the Baseline Visit (Visit 2)
  • Subject is receiving therapy with 1 of the following drugs either concurrently or within 28 days prior to Baseline (Visit 2): Alpha-methyl dopa, Metoclopramide, Reserpine, Neuroleptics (except specific atypical neuroleptics: Olanzapine, Ziprasidone, Aripiprazole, Clozapine, quetiapine), MAO-A inhibitors, Methylphenidate, or Amphetamine
  • Subject is currently receiving central nervous system (CNS) active therapy (eg, sedatives, hypnotics, antidepressants, anxiolytics), unless the dose has been stable for at least 28 days prior to Baseline (Visit 2) and is likely to remain stable for the duration of the study
  • Subject has a current diagnosis of Epilepsy, has a history of seizures as an adult, has a history of stroke, or has had a transient ischemic attack within 1 year prior to Screening (Visit 1)
  • Subject has clinically relevant hepatic dysfunction (as defined as a total bilirubin >2.0 mg/dL, or Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) >2 times the upper limit of the reference range)
  • Subject has clinically relevant renal dysfunction (serum creatinine >2.0 mg/dL [>178 μmol/L])
  • Subject has clinically relevant cardiac dysfunction (any cardiac disorder which in the opinion of the investigator would put the subject at risk of clinically relevant arrhythmia) and/or myocardial infarction within the last 12 months
  • Subject has a QT interval corrected for heart rate according to Bazett's formula (QTcB) of ≥500 ms at Screening (Visit 1)
  • Subject has a history of only symptomatic (not asymptomatic) orthostatic hypotension, with a decrease of systolic blood pressure (SBP) from supine to standing position of ≥2 0 mmHg or of ≥10 mmHg in DBP after 1 or 3 minutes within 28 days prior to Baseline (Visit 2), or SBP <105 mmHg at study entry 17. Subject has evidence of an impulse control disorder (ICD) at Screening (Visit 1)
  • Subject has a history of known intolerance/hypersensitivity to the following Antiemetics: Domperidone, Trimethobenzamide, Ondansetron, Tropisetron, Granisetron, and Glycopyrrolate
  • Subject has a history of chronic alcohol or drug abuse within the last 5 years
  • Subject is pregnant or nursing, or is of childbearing potential but (i) not surgically sterile or (ii) not using adequate birth control methods (including at least a double barrier method) or (iii) not sexually abstinent or (iv) not at least 2 years post-menopausal
  • Subject has any other clinically relevant medical condition, psychiatric condition, or laboratory abnormality which would, in the judgment of the investigator, interfere with the subject's ability to participate in the study

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

China24 sites

  • Sp1037 001

    Beijing

  • Sp1037 002

    Beijing

  • Sp1037 019

    Beijing

  • Sp1037 025

    Beijing

  • Sp1037 017

    Changchun

  • Sp1037 007

    Chengdu

  • Sp1037 027

    Chengdu

  • Sp1037 021

    Fuzhou

  • Sp1037 010

    Guangzhou

  • Sp1037 011

    Guangzhou

  • Sp1037 014

    Guangzhou

  • Sp1037 015

    Guangzhou

  • Sp1037 005

    Hangzhou

  • Sp1037 013

    Hangzhou

  • Sp1037 018

    Hangzhou

  • Sp1037 023

    Jinan

  • Sp1037 003

    Shanghai

  • Sp1037 004

    Shanghai

  • Sp1037 009

    Shanghai

  • Sp1037 008

    Suzhou

  • Sp1037 016

    Tianjin

  • Sp1037 006

    Wuhan

  • Sp1037 022

    Wuhan

  • Sp1037 024

    Wuhan

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of The Efficacy And Safety of Rotigotine Transdermal Patch In Chinese Subjects With Advanced-stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled On Levodopa

The primary objective of this study was to demonstrate that Rotigotine transdermal patch is efficacious in Chinese subjects with advanced-stage Idiopathic Parkinson's Disease as an adjuvant therapy.

Read the detailed description

The study included a maximum 4-week Screening Period, a maximum 7-week Titration Period for advanced-stage Parkinson's disease, 12-week Maintenance Period, a maximum 12-day De-escalation Period for advanced-stage Parkinson's Disease and 30-day Safety Follow-Up Period. The maximum study duration for an individual subject with advanced-stage Parkinson's disease was 27 weeks.

Being tested
Rotigotine, Placebo Patch, L-dopa
Keywords
Rotigotine, Neupro phase 3, Advanced-stage, Idiopathic Parkinson's Disease
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RotigotineDrug

    Transdermal Patch

    Content:

    4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)

    For advanced-stage Parkinson's Disease, subjects received Rotigotine patches in escalating weekly dose (starting with daily doses 4 mg/24 h to 16 mg/24 h) for a maximum 7-week Titration Period, then 12 week maintenance period

  • Placebo PatchDrug

    Transdermal Patch

    Size:

    20 cm^2, 30 cm^2, 40 cm^2

    Subjects randomized to placebo received matching placebo patches

  • L-dopaDrug

    Also called Levodopa

    Subject must be on a stable dose of L-dopa (either short-acting or sustained release [in combination with benserazide or carbidopa]) of at least 200 mg/day, administered in at least 2 intakes, for at least 28 days prior to Baseline.

Study groups in NCT01646255
Study groupRoleWhat they receive
RotigotineExperimentalRotigotine, daily doses, treatment group
Receives: Drug: Rotigotine; Drug: L-dopa
PlaceboPlacebo comparatorPlacebo, daily doses, placebo group
Receives: Drug: Placebo Patch; Drug: L-dopa

What is being measured

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

  1. Absolute Change in Absolute Time Spent 'Off' From Baseline to the End of Double-blind Maintenance Period

    A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication. A negative mean indicates a reduction of the time off during the conduct of the study

    Measured: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Secondary outcomes (12)

  1. Percentage of Responders From Baseline to the End of the Doubleblind Maintenance Period

    A Responder is defined as a subject with an ≥ 30 % decrease in absolute time spent 'off'

    Measured: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

  2. Percent Change in Absolute Time Spent "Off" From Baseline to the End of Double-blind Maintenance Period

    A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication.

    Absolute time "off" is defined as the mean number of hours marked "off" during a 24-hour period from all valid daily diary cards.

    Measured: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

  3. Percent Change in Relative Time Spent "Off" From Baseline to the End of Double-blind Maintenance Period

    A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication.

    Relative time spent "off" will be calculated in two stages. Each valid daily diary will have an associated relative time "off" calculated as relative time "off" for day = 100*[total absolute time "off" for day/ absolute time awake for day]. Relative time spent "off" is then calculated by averaging the daily relative time "off" for the valid days of that visit.

    Measured: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

  4. Change in Absolute Time Spent "on" From Baseline to the End of Double-blind Maintenance Period

    A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'.

    Absolute time "on" is defined as the mean number of hours marked "on" during a 24-hour period from all valid daily diary cards.

    Measured: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

  5. Change in Relative Time Spent "on" From Baseline to the End of Double-blind Maintenance Period

    A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was "off" when taking his/her L-dopa, he/she recorded the exact time their status changed to "on".

    Relative time spent "on" will be calculated in two stages. Each valid daily diary will have an associated relative time "on" calculated as relative time "on" for day = 100*[total absolute time "on" for day/ absolute time awake for day]. Relative time spent "on" is then calculated by averaging the daily relative time "on" for the valid days of that visit.

    Measured: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

  6. Percent Change in Absolute Time Spent "on" From Baseline to the End of Double-blind Maintenance Period

    A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'.

    Note for percent change calculations: when absolute time at Baseline was 0 hours, the absolute Baseline value was assumed to be 1 minute for calculation purposes.

    Measured: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

  7. Percent Change in Relative Time Spent "on" From Baseline to the End of Double-blind Maintenance Period

    A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was "off" when taking his/her L-dopa, he/she recorded the exact time their status changed to "on".

    Note for percent change calculations: when relative time at Baseline was 0%, the relative Baseline value was assumed to be 0.1 for calculation purposes.

    Relative time spent "on" will be calculated in two stages. Each valid daily diary will have an associated relative time "on" calculated as relative time "on" for day = 100*[total absolute time "on" for day/ absolute time awake for day]. Relative time spent "on" is then calculated by averaging the daily relative time "on" for the valid days of that visit.

    Measured: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

  8. Change in the Number of "Off" Periods From Baseline to the End of Double-blind Maintenance Period

    A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication.

    Measured: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

  9. Change in Status of the Subject (on) After Wake-up With Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period

    A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'.

    The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the "on with troublesome dyskinesia" state is presented below.

    Measured: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

  10. Change in Status of the Subject (on) After Wake-up Without Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period

    A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'.

    The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the "on without troublesome dyskinesia" state is presented below.

    Measured: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

  11. Change in Status of the Subject (Off) After Wake-up From Baseline to the End of Double-blind Maintenance Period

    A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication.

    The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the "off" state is presented below.

    Measured: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

  12. Change in Unified Parkinson's Disease Rating Scale (UPDRS Part III Motor Examination) During "on" Periods From Baseline to the End of Double-blind Maintenance Period

    The UPDRS Part III (motor subscale) assessment consists of 27 questions, measured on a 5-Point scale (0 to 4). The sum score is calculated as sum of these 27 individual questions. This score ranges from 0 to 108, higher scores denote greater disability.

    A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'.

    Measured: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionOct 2014
  4. Study completionOct 2014

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
346 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01646255
Sponsor's protocol ID
SP1037
Status last verified
Mar 2018
First submitted
18 Jul 2012
Last updated
4 Apr 2018
Data monitoring committee
No

Publications

  • Zhang ZX, Liu CF, Tao EX, Shao M, Liu YM, Wang J, Asgharnejad M, Xue HB, Surmann E, Bauer L. Rotigotine transdermal patch in Chinese patients with advanced Parkinson's disease: A randomized, double-blind, placebo-controlled pivotal study. Parkinsonism Relat Disord. 2017 Nov;44:6-12. doi: 10.1016/j.parkreldis.2017.08.015. Epub 2017 Aug 10.

    PubMed 28827011

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rotigotine and L-dopa in people with Idiopathic Parkinson's Disease, run by UCB Pharma at 24 sites in China.

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 13 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 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in China. 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 22 Jan 2016). 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?

Absolute Change in Absolute Time Spent 'Off' From Baseline to the End of Double-blind Maintenance Period (time frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)). 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 NCT01646255, which also lists 1 linked publication.

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 4 Apr 2018.

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