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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01536015
• Date of registration: 15/02/2012
• Prospective Registration: No
• Primary sponsor: UCB Pharma
• Public title: Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease (PD) With Motor Fluctuations and Symptoms of Gastrointestinal Dysfunction ROADMAP
• Scientific 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
• Date of first enrolment: January 2012
• Target sample size: 25
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01536015
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: UCB Clinical Trial Call Center
• Affiliation: 877-822-9493

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

- 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

Exclusion Criteria:

- 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

- 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



Age minimum: 30 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Advanced Parkinson's Disease

Intervention(s)

Drug: Rotigotine

Drug: Placebo

Primary Outcome(s)

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]

Secondary Outcome(s)

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 [Time Frame: Baseline to 10 weeks]

Change in Score on Fatigue Severity Scale (FSS) From Baseline to the End of 7-week Maintenance Period [Time Frame: Baseline to 10 weeks]

Change in Predictability of "Off" Time (Using MDS UPDRS Part IV Item 4.5) From Baseline to End of the 7-week Maintenance Period [Time Frame: Baseline to 10 weeks]

Change in Score on Gastrointestinal Neurodegenerative Scale (GIND) From Baseline to the End of the of the 7-week Maintenance Period [Time Frame: Baseline to 10 weeks]

Change in Score on Parkinson's Disease Questionnaire (PDQ8) From Baseline to the End of 7-week Maintenance Period [Time Frame: Baseline to 10 weeks]

Secondary ID(s)

SP1055

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 01/08/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01536015