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

Advanced Parkinson's Disease Clinical Trial

— ROADMAP  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01536015
• Other study ID #: SP1055
• Status: Terminated
• Phase: Phase 3
• First received: February 15, 2012
• Last updated: July 7, 2014
• Start date: January 2012
• Est. completion date: October 2013

Study information

• Verified date: July 2014
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Parkinson's Disease
• Parkinson Disease

Intervention

Drug:
• Rotigotine
Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours Dosage and Frequency: One patch every 24 hours Duration: 10 weeks
• Placebo
Frequency: One patch applied every 24 hours Duration: 10 weeks

Locations

Country	Name	City	State
United States	032	Annapolis	Maryland
United States	011	Birmingham	Alabama
United States	034	Charlotte	North Carolina
United States	016	Commack	New York
United States	031	Cordova	Tennessee
United States	022	Fountain Valley	California
United States	008	Gainesville	Florida
United States	001	Gilbert	Arizona
United States	014	Houston	Texas
United States	017	Irvine	California
United States	012	Kirkland	Washington
United States	027	Lincoln	Nebraska
United States	018	Memphis	Tennessee
United States	009	Miami	Florida
United States	013	Milwaukee	Wisconsin
United States	026	Mineola	New York
United States	010	Ormond Beach	Florida
United States	028	Pasadena	California
United States	002	Raleigh	North Carolina
United States	030	Richmond	Virginia
United States	007	Salisbury	North Carolina
United States	015	Sunnyvale	California
United States	006	Sunrise	Florida
United States	021	Toledo	Ohio
United States	023	Tulsa	Oklahoma
United States	003	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 10 weeks	No
Secondary	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).	Baseline to 10 weeks	No
Secondary	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).	Baseline to 10 weeks	No
Secondary	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).	Baseline to 10 weeks	No
Secondary	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).	Baseline to 10 weeks	No
Secondary	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).	Baseline to 10 weeks	No

External Links

•   FDA safety Alerts and Recalls
•   Product information