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Parkinson's DiseasePhase 3NCT00522379

Trial to Assess Parkinson's Disease (PD) Symptom Control to Four Doses of Rotigotine in a Transdermal Patch

A Phase 3 study testing Rotigotine in people with Parkinson's Disease, run by UCB Pharma at 77 sites in 5 countries.

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 purpose of this study is to show Rotigotine dose response at four doses of Rotigotine used with L-dopa in treating advanced stage Parkinson's disease. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Parkinson's Disease
What is being tested?
Rotigotine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
514 participants
Where
77 sitesin 5 countries
Study dates
Jul 2007to Jul 2011
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

  • PD greater than 3 years
  • Stable dose L-dopa but symptoms not adequately controlled and have "off" time
  • Able and willing to complete diary on specific days

Who cannot join

  • Previous use of rotigotine or Neupro
  • Atypical Parkinson's syndrome
  • Pallidotomy
  • Thalamotomy
  • Deep brain stimulation
  • Fetal tissue transplant
Show all 17Show fewer
  • Dementia
  • Psychosis
  • Hallucinations
  • Epilepsy
  • Renal or hepatic dysfunction
  • Clinically relevant cardiac dysfunction
  • Symptomatic orthostatic hypotension
  • Skin sensitivity to adhesives or unresolved contact dermatitis
  • History of chronic alcohol or drug abuse
  • Pregnant or of child-bearing potential
  • Impulse control disorder

Trial locations and contacts

77 sites in 5 countries.

77 sites in 5 countries

United States62 sites

  • Study site

    Alexandria, Virginia

  • Study site

    Anderson, Indiana

  • Study site

    Atlanta, Georgia

  • Study site

    Aurora, Colorado

  • Study site

    Birmingham, Alabama

  • Study site

    Boca Raton, Florida

  • Study site

    Bradenton, Florida

  • Study site

    Chicago, Illinois

  • Study site

    Columbus, Ohio

  • Study site

    Commack, New York

  • Study site

    Decatur, Georgia

  • Study site

    Des Moines, Iowa

  • Study site

    Fountain Valley, California

  • Study site

    Fresno, California

  • Study site

    Gilbert, Arizona

  • Study site

    Golden Valley, Minnesota

  • Study site

    Greensburg, Pennsylvania

  • Study site

    Irvine, California

  • Study site

    Jacksonville, Florida

  • Study site

    Kansas City, Kansas

  • Study site

    Kirkland, Washington

  • Study site

    La Jolla, California

  • Study site

    Las Vegas, Nevada

  • Study site

    Little Rock, Arkansas

  • Study site

    Loma Linda, California

  • Study site

    Louisville, Kentucky

  • Study site

    Lubbock, Texas

  • Study site

    Macon, Georgia

  • Study site

    Memphis, Tennessee

  • Study site

    Miami, Florida

  • Study site

    Midvale, Utah

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Missoula, Montana

  • Study site

    Naples, Florida

  • Study site

    New Haven, Connecticut

  • Study site

    New York, New York

  • Study site

    Ocala, Florida

  • Study site

    Omaha, Nebraska

  • Study site

    Ormond Beach, Florida

  • Study site

    Oxnard, California

  • Study site

    Peoria, Arizona

  • Study site

    Phoenix, Arizona

  • Study site

    Pompano Beach, Florida

  • Study site

    Raleigh, North Carolina

  • Study site

    Richmond, Virginia

  • Study site

    Roanoke, Virginia

  • Study site

    Rochester, New York

  • Study site

    Salisbury, North Carolina

  • Study site

    San Antonio, Texas

  • Study site

    Scottsdale, Arizona

  • Study site

    Souderton, Pennsylvania

  • Study site

    South Ogden, Utah

  • Study site

    Southfield, Michigan

  • Study site

    Spokane, Washington

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    Sunrise, Florida

  • Study site

    Suwanee, Georgia

  • Study site

    Toledo, Ohio

  • Study site

    Tuscaloosa, Alabama

  • Study site

    Upland, Pennsylvania

  • Study site

    Virginia Beach, Virginia

Other trials in United States

India10 sites

  • Study site

    Bangalore, Kamataka

  • Study site

    Calicut, Kerala

  • Study site

    Chennai, Tamil Nadu

  • Study site

    Hyderbad, Andhra Pradesh

  • Study site

    Indore, Madhya Pradesh

  • Study site

    Mangalore, Kamataka

  • Study site

    Mumbai, Maharashtra

  • Study site

    Mysore, Karnataka

  • Study site

    Pune, Maharashtra

  • Study site

    Thiruvananthapuram, Kerala

Other trials in India

Mexico2 sites

  • Study site

    Aguascalientes, Aguascalientes

  • Study site

    Monterrey, Nuevo León

Other trials in Mexico

Peru2 sites

  • Study site

    San Isidro, Lima region

  • Study site

    Santiago de Surco, Lima region

Other trials in Peru

Chile1 site

  • Study site

    Santiago, Chile

Other trials in Chile

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, 5-arm, Parallel-group Trial to Assess Rotigotine Transdermal System Dose Response in Subjects With Advanced-stage Parkinson's Disease

The purpose of this study is to show Rotigotine dose response at four doses of Rotigotine used with L-dopa in treating advanced stage Parkinson's disease.

Read the detailed description

To maintain treatment blind, two different active patch sizes were used (10 cm^2 \& 20 cm^2). Placebo patches matched according to size and appearance. During the trial subjects applied up to three patches, active and placebo, to achieve their assigned daily dose.

Being tested
Rotigotine, Placebo
Keywords
Parkinson's disease, rotigotine, patch, transdermal, dopamine agonist, off time, Neupro
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

    Also called Neupro

    2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks

  • RotigotineDrug

    Also called Neupro

    4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks

  • PlaceboOther

    Placebo transdermal patch applied daily

  • RotigotineDrug

    Also called Neupro

    6 mg/24 hr (one 10 cm^2 \& one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks

  • RotigotineDrug

    Also called Neupro

    8 mg/24 hr (two 10 cm^2 \& one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks

Study groups in NCT00522379
Study groupRoleWhat they receive
Rotigotine 2 mg/24 hrExperimentalNot described
Receives: Drug: Rotigotine
Rotigotine 4 mg/24 hrExperimentalNot described
Receives: Drug: Rotigotine
Rotigotine 6 mg/24 hrExperimentalNot described
Receives: Drug: Rotigotine
Rotigotine 8 mg/24 hrExperimentalNot described
Receives: Drug: Rotigotine
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

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

  1. The Change in the Absolute Time Spent "Off" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary

    Time "Off" is defined as when the patient does not have the effect of anti-Parkinson's medication.

    Measured: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].

Secondary outcomes (18)

  1. The Change in Relative Time Spent "Off" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary

    Time "Off" is defined as when the patient does not have the effect of anti-Parkinson's medication.

    Measured: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].

  2. The Change in the Absolute Time Spent "on" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary

    Time "On" is defined as when the patient has the effect of anti-Parkinson's medication.

    Measured: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].

  3. The Change in the Relative Time Spent "on" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary

    Time "On" is defined as when the patient has the effect of anti-Parkinson's medication.

    Measured: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].

  4. The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary

    Measured: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].

  5. The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II From Baseline to the End of the Maintenance Period

    The Unified Parkinson's Disease Rating Scale (UPDRS) Part II is a scale for the assessment of function in Parkinson's disease. UPDRS Part II measures Activities of Daily Living. It consists of 13 questions, each ranging from 0 to 4. The sum score of the UPDRS Part II ranges from 0 to 52. A higher score indicates greater disability. A negative change score indicates improvement.

    Measured: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].

  6. The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III From Baseline to the End of the Maintenance Period

    The Unified Parkinson's Disease Rating Scale (UPDRS) Part III is a scale for the assessment of function in Parkinson's disease. UPDRS Part III measures Motor Function. It consists of 14 items with 27 questions, each ranging from 0 to 4. The sum score for the UPDRS Part III ranges from 0 to 108. A higher score indicates greater disability. A negative change score indicates improvement.

    Measured: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].

  7. The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present?

    Item = Duration (question #32) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - What proportion of the waking day are dyskinesias present? Has a possible score of 0 - 4 points (4 = maximum). A higher score indicates more severe symptoms.

    Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.

    Measured: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].

  8. The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias?

    Item = Disability (question #33) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - How disabling are the dyskinesias? Has a possible score of 0 - 4 points (4 = maximum). A higher score indicates more severe symptoms.

    Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.

    Measured: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].

  9. The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias?

    Item = Painful Dyskinesia (question #34) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - How painful are the dyskinesias? Has a possible score of 0 - 4 points (4 = maximum). A higher score indicates more severe symptoms.

    Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.

    Measured: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].

  10. The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia

    Item = Presence of Early Morning Dystonia (question #35) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates early morning dystonia.

    Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.

    Measured: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].

  11. The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are "Off" Periods Predictable?

    Item = Are "off" periods predictable (question #36) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates "off" periods are predictable.

    Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.

    Measured: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].

  12. The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are "Off" Periods Unpredictable?

    Item = Are "off" periods unpredictable (question #37) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates "off" periods are unpredictable.

    Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.

    Measured: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].

  13. The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do "Off" Periods Come on Suddenly?

    Item = Do "off" periods come on suddenly, within a few seconds (question #38) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates "off" periods come on suddenly, within a few seconds.

    Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.

    Measured: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].

  14. The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject "Off", on Average?

    Item = What proportion of the waking day is the subject "off", on average (question #39) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 - 4 points (4 = maximum). A higher score indicates the subject is "off" a larger portion of the waking day.

    Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.

    Measured: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].

  15. The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting?

    Item = Does the patient have anorexia, nausea, or vomiting (question #40) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has anorexia, nausea, or vomiting.

    Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.

    Measured: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].

  16. The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence?

    Item = Does the patient have any sleep disturbances such as insomnia or hypersomnolence (question #41) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has sleep disturbances such as insomnia or hypersomnolence.

    Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.

    Measured: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].

  17. The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis?

    Item = Does the patient have symptomatic orthostasis (question #42) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has symptomatic orthostasis.

    Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.

    Measured: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].

  18. The Change in Number of "Off" Periods From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary

    Time "Off" is defined as when the patient does not have the effect of anti-Parkinson's medication.

    Measured: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].

Timeline

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

  1. First posted29 Aug 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionJul 2011
  4. Study completionJul 2011

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
514 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00522379
Sponsor's protocol ID
SP0921
Status last verified
Dec 2012
First submitted
28 Aug 2007
Last updated
27 Oct 2014
Data monitoring committee
No

Publications

  • LeWitt PA, Poewe W, Elmer LW, Asgharnejad M, Boroojerdi B, Grieger F, Bauer L. The Efficacy Profile of Rotigotine During the Waking Hours in Patients With Advanced Parkinson's Disease: A Post Hoc Analysis. Clin Neuropharmacol. 2016 Mar-Apr;39(2):88-93. doi: 10.1097/WNF.0000000000000133.

    PubMed 26882318

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rotigotine in people with Parkinson's Disease, run by UCB Pharma at 77 sites in 5 countries.

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 3 inclusion and 17 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 27 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States, India, Mexico, Peru, Chile. 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 10 Dec 2012). 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?

The Change in the Absolute Time Spent "Off" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary (time frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].). 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 NCT00522379, 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 27 Oct 2014.

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