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Advanced Parkinson's DiseasePhase 3ROADMAPNCT01536015

Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease (PD) With Motor Fluctuations and Symptoms of Gastrointestinal Dysfunction

A Phase 3 study testing Rotigotine in people with Advanced Parkinson's Disease, run by UCB Pharma at 26 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary purpose is to demonstrate superiority of Rotigotine over Placebo on motor symptoms when used in subjects with symptoms of Gastrointestinal Dysfunction. Hypothesis: Rotigotine will decrease OFF time compared to Placebo. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Advanced Parkinson's Disease
What is being tested?
Rotigotine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
26 sitesUnited States
Study dates
Jan 2012to Oct 2013
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

  • Subject is informed and given ample time and opportunity to think about his/her participation in this study and has given his/her written informed consent on an Institutional Review Board approved consent form
  • Subject is willing and able to comply with all study requirements (protocol, visit schedule, procedures, and medication application)
  • Subject is male or female and ≥ 30 years of age
  • Subject has Idiopathic Parkinson's Disease of more than 3 years duration, as defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: resting tremor, rigidity, impairment of postural reflexes; and is without any other known or suspected cause of Parkinsonism
  • Subject has a Hoehn \& Yahr stage score II through IV
  • 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 21 days prior to starting Parkinson's diaries
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  • Subject must be able to differentiate between the "on" and "off" state (and thereby be able to recognize the Time To "On" (TTON)), and be willing and able to accurately complete a Parkinson's Disease subject diary on designated days (with assistance from caregivers, if required)
  • Subject must complete 6 Parkinson's diaries over a period of 6 days, with 4 of the 6 Parkinson's diaries being "valid" as determined by the investigator. The "valid" Parkinson's diaries confirm that the subject has an average of at least 2.5 h/day spent in the "off" state
  • Subject receiving a Monoamine Oxidase (MAO)-B Inhibitor (eg, Selegiline or Rasagiline), an n-Methyl-d-Aspartate Antagonist (eg, Amantadine), or allowed anti-Parkinson medications and has been on a stable dose for at least 21 days prior to starting Parkinson's diaries and is anticipated to be maintained on that dose for the duration of the study
  • Subject has clinical symptoms of Gastrointestinal Dysfunction (GID) confirmed by at least 1 of the following
  • •Parkinson's disease-related GI symptoms as per the Gastrointestinal Degenerative Scale (GIND) Scale: defecatory dysfunction, constipation, excessive gas, abdominal pain, bloating, nausea, vomiting, anorexia, early satiety, or weight loss (except sialorrhea and dysphagia)
  • Female subjects of childbearing potential must agree to use 1 of the following contraceptive methods: oral contraceptive, intrauterine device, or double-barrier method, throughout the study and for 2 weeks after the removal of study medication

Who cannot join

  • Subject has previously participated in this study
  • Subject has participated in another study of an investigational medicinal product (IMP) or a medical device within the last 30 days or is currently participating in another study of an IMP or a medical device
  • Subject has an Atypical Parkinsonian Syndrome 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
  • Subject has Dementia, Active Psychosis, or Hallucinations
  • Subject exhibits Dopaminergic Dysregulation Syndrome
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  • Subject is receiving therapy with certain medications in a specific timeframe as specified in the protocol
  • Subject has history of chronic Gastrointestinal (GI) Disease not related to Parkinson's disease which in the judgement of the investigator may affect the ability of the subject to participate in the study (ie, Irritable Bowel Syndrome, Diverticulitis, Crohn's Disease, etc) or GI/abdominal surgery (except for Appendectomy, Hysterectomy, or Cholecystectomy)
  • Subject has had any GI surgery in the 3 months prior to the Screening Visit
  • Subject has a current diagnosis of Epilepsy, has a history of seizures as an adult, or has a history of stroke or Transient Ischemic Attack within 1 year prior to the Screening Visit
  • Subject has clinically relevant Hepatic or Renal Dysfunction
  • Subject has clinically relevant Cardiac Dysfunction (any cardiac disorder that in the opinion of the investigator would put the subject at risk of clinically relevant arrhythmia)
  • Subject has had a Myocardial Infarction within the last 1 year prior to the Screening Visit
  • Subject has a history of Symptomatic (not Asymptomatic) Orthostatic Hypotension
  • Subject has a Systolic Blood Pressure (BP) < 105 mmHg at the Screening Visit
  • Subject has a history of chronic alcohol or drug abuse within the prior 6 months
  • Female subject is pregnant or lactating
  • Subject (male or female) is of child bearing potential but not surgically sterile or not using adequate birth control methods
  • Subject has evidence of an Impulse Control Disorder according to the Modified Minnesota Impulsive Disorders Interview (mMIDI) at the Screening Visit
  • Subject has a lifetime history of suicide attempt (including an active 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 the Screening Visit
  • Subject has a significant skin disease/condition that would make transdermal drug use inappropriate, including a history of skin sensitivity to adhesives or other transdermal medications
  • Subject has a known hypersensitivity to any components of the Rotigotine patch, including Sodium Metabisulfite
  • Subject has any medical, psychiatric, or cognitive condition, or laboratory abnormality that would, in the opinion of the investigator, jeopardize or compromise the subject's well-being or ability to participate in the study

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

United States26 sites

  • 032

    Annapolis, Maryland

  • 011

    Birmingham, Alabama

  • 034

    Charlotte, North Carolina

  • 016

    Commack, New York

  • 031

    Cordova, Tennessee

  • 022

    Fountain Valley, California

  • 008

    Gainesville, Florida

  • 001

    Gilbert, Arizona

  • 014

    Houston, Texas

  • 017

    Irvine, California

  • 012

    Kirkland, Washington

  • 027

    Lincoln, Nebraska

  • 018

    Memphis, Tennessee

  • 009

    Miami, Florida

  • 013

    Milwaukee, Wisconsin

  • 026

    Mineola, New York

  • 010

    Ormond Beach, Florida

  • 028

    Pasadena, California

  • 002

    Raleigh, North Carolina

  • 030

    Richmond, Virginia

  • 007

    Salisbury, North Carolina

  • 015

    Sunnyvale, California

  • 006

    Sunrise, Florida

  • 021

    Toledo, Ohio

  • 023

    Tulsa, Oklahoma

  • 003

    Virginia Beach, Virginia

Other trials in United States

About this study

Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease With Motor Fluctuations and Symptoms of Gastrointestinal Dysfunction

The primary purpose is to demonstrate superiority of Rotigotine over Placebo on motor symptoms when used in subjects with symptoms of Gastrointestinal Dysfunction. Hypothesis: Rotigotine will decrease OFF time compared to Placebo.

Being tested
Rotigotine, Placebo
Keywords
Rotigotine, Neupro®, Levodopa, Gastrointestinal Dysfunction

What participants receive

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

  • RotigotineDrug

    Also called Neupro®

    Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours

    Dosage and Frequency: One patch every 24 hours

    Duration: 10 weeks

  • PlaceboDrug

    Frequency: One patch applied every 24 hours

    Duration: 10 weeks

Study groups in NCT01536015
Study groupRoleWhat they receive
RotigotineExperimentalRotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.
Receives: Drug: Rotigotine
PlaceboPlacebo comparatorPlacebo patch.
Receives: Drug: Placebo

What is being measured

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

  1. Change in Rotigotine Versus Placebo in the Absolute Time Spent "Off" From Baseline to the End of the 7-week Maintenance Period

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

    Measured: Baseline to 10 weeks

Secondary outcomes (5)

  1. Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part III (Motor Examination) in the "on" State From Baseline to the End of the 7-week Maintenance Period

    The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part III is an 18-item scale with each single item of the scale ranging from 0 (normal) to 4 (severe).

    Measured: Baseline to 10 weeks

  2. Change in Predictability of "Off" Time (Using MDS UPDRS Part IV Item 4.5) From Baseline to End of the 7-week Maintenance Period

    The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part IV is a 6-item scale with each single item of the scale ranging from 0 (normal) to 4 (severe).

    Measured: Baseline to 10 weeks

  3. Change in Score on Gastrointestinal Neurodegenerative Scale (GIND) From Baseline to the End of the of the 7-week Maintenance Period

    Gastrointestinal Neurodegenerative Scale (GIND) is an 18-item scale measuring gastrointestinal dysfunction with each single item of the scale ranging from 0 (never or not at all) to 5 (very severe).

    Measured: Baseline to 10 weeks

  4. Change in Score on Fatigue Severity Scale (FSS) From Baseline to the End of 7-week Maintenance Period

    The Fatigue Severity Scale is a 9-item scale measuring the impact of fatigue on everyday functioning (e.g. "fatigue interferes with my work, each single item of the scale ranging from 1 (disagree) to 7 (agree).

    Measured: Baseline to 10 weeks

  5. Change in Score on Parkinson's Disease Questionnaire (PDQ8) From Baseline to the End of 7-week Maintenance Period

    The Parkinson's Disease Questionnaire (PDQ-8) is a self-administered 8-item questionnaire that assesses issues associated with Parkinson's disease. Each single item of the 8-item questionnaire ranges from 0 (never) to 4 (always).

    Measured: Baseline to 10 weeks

Timeline

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

  1. First posted20 Feb 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionOct 2013
  4. Study completionOct 2013

Why it stopped: The study was stopped due to low enrollment.

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01536015
Sponsor's protocol ID
SP1055
Acronym
ROADMAP
Status last verified
Jul 2014
First submitted
15 Feb 2012
Last updated
1 Aug 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rotigotine in people with Advanced Parkinson's Disease, run by UCB Pharma at 26 sites in United States.

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 12 inclusion and 23 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: stopped early, as of the sponsor's last update on 1 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States. 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 1 Aug 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?

Change in Rotigotine Versus Placebo in the Absolute Time Spent "Off" From Baseline to the End of the 7-week Maintenance Period (time frame: Baseline to 10 weeks). 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 NCT01536015.

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 1 Aug 2014.

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