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

NCT01536015 | Terminated Phase 3 Results

• 1 other identifier: SP1055
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 26

Brief 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.

Conditions

Advanced Parkinson's Disease

Keywords

Rotigotine; Neupro®; Levodopa; Gastrointestinal Dysfunction

Outcome Measures

Primary Outcomes (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.

  Baseline to 10 weeks

Secondary Outcomes (5)

• 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

  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

  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

  Baseline to 10 weeks

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

  Baseline to 10 weeks

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

  Baseline to 10 weeks

Study Arms (2)

Rotigotine

EXPERIMENTAL

Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.

Drug: Rotigotine

Placebo

PLACEBO COMPARATOR

Placebo patch.

Drug: Placebo

Interventions

Rotigotine DRUG

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

Also known as: Neupro®

Rotigotine

Placebo DRUG

Frequency: One patch applied every 24 hours Duration: 10 weeks

Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (26)

011

Birmingham, Alabama, United States

Location

001

Gilbert, Arizona, United States

Location

022

Fountain Valley, California, United States

Location

017

Irvine, California, United States

Location

028

Pasadena, California, United States

Location

015

Sunnyvale, California, United States

Location

008

Gainesville, Florida, United States

Location

009

Miami, Florida, United States

Location

010

Ormond Beach, Florida, United States

Location

006

Sunrise, Florida, United States

Location

032

Annapolis, Maryland, United States

Location

027

Lincoln, Nebraska, United States

Location

016

Commack, New York, United States

Location

026

Mineola, New York, United States

Location

034

Charlotte, North Carolina, United States

Location

002

Raleigh, North Carolina, United States

Location

007

Salisbury, North Carolina, United States

Location

021

Toledo, Ohio, United States

Location

023

Tulsa, Oklahoma, United States

Location

031

Cordova, Tennessee, United States

Location

018

Memphis, Tennessee, United States

Location

014

Houston, Texas, United States

Location

030

Richmond, Virginia, United States

Location

003

Virginia Beach, Virginia, United States

Location

012

Kirkland, Washington, United States

Location

013

Milwaukee, Wisconsin, United States

Location

Related Links

• FDA safety Alerts and Recalls

MeSH Terms

Interventions

rotigotine

Results Point of Contact

• Title: UCB Clinical Trial Call Center
• Organization: UCB

+1 877 822 9493

Study Officials

• UCB Clinical Trial Call Center

  877-822-9493

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2012
• First Posted: February 20, 2012
• Study Start: January 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: August 1, 2014
• Results First Posted: August 1, 2014

Record last verified: 2014-07

Locations

US (26)