Trial to Evaluate The Efficacy Of Rotigotine on Parkinson's Disease-Associated Motor Symptoms And Apathy - Full Text View

Purpose

This trial is being conducted to assess the effects of Rotigotine over Placebo on improvement of Apathy and motor symptoms in subjects with early-stage and advanced stage idiopathic Parkinson´s Disease.

Condition	Intervention	Phase
Idiopathic Parkinson's Disease	Drug: Rotigotine Other: Placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Multicenter, Multinational, Double-Blind, Placebo-Controlled, 3-Arm, Phase 4 Study To Evaluate The Efficacy Of Rotigotine On Parkinson's Disease-Associated Apathy, Motor Symptoms, And Mood

Resource links provided by NLM:

Genetics Home Reference related topics: Parkinson disease Perry syndrome

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Rotigotine

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Change from Baseline to the End of the Maintenance Period in the score of the Apathy Evaluation Scale (AS) rated by the patient [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline) ] [ Designated as safety issue: No ]
Change from Baseline to the End of the Maintenance Period in the total score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II (activities of daily living) + III (motor symptoms) [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from Baseline to the End of the Maintenance Period in the score of the Apathy Evaluation Scale (AS) rated by the caregiver (where available) [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline) ] [ Designated as safety issue: No ]
Change from Baseline to the End of the Maintenance Period in the sum score of the 8-item Parkinson's Disease Questionnaire (PDQ-8) [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline) ] [ Designated as safety issue: No ]
Change from Baseline to the End of the Maintenance Period in the sum score of the mood / cognition domain of the Nonmotor Symptom Assessment Scale (NMSS) [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline) ] [ Designated as safety issue: No ]
Change from Baseline to the End of the Maintenance Period in the sum score of the Snaith Hamilton Pleasure Scale (SHAPS) [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline) ] [ Designated as safety issue: No ]
Change from Baseline to the End of the Maintenance Period in the sum score of the Beck Depression Inventory Second Edition (BDI-II) [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline) ] [ Designated as safety issue: No ]
Change from Baseline to the End of the Maintenance Period in the sum score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part III (motor subscale) in "on" state [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline) ] [ Designated as safety issue: No ]
Change from Baseline to the End of the Maintenance Period in the score of the Clinical Global Impression Scale (CGI) Item I (Severity of Illness) [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period/Early Withdrawal (up to 19 weeks after Baseline) ] [ Designated as safety issue: No ]

Estimated Enrollment:	504
Study Start Date:	February 2013
Estimated Study Completion Date:	April 2015
Estimated Primary Completion Date:	February 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Rotigotine, high dose Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease	Drug: Rotigotine Rotigotine, transdermal patches: 10 cm2 (2 mg / 24 hours); 20 cm2 (4 mg / 24 hours); 30 cm2 (6 mg / 24 hours); 40 cm2 (8 mg / 24 hours) Optimal dosage: The maximum Rotigotine dose allowed is 8 mg / 24 hours or 16 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours or 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation) Other Name: (6S)-6-propyl-[2 (2 thienyl)ethyl]amino-5,6,7,8-tetrahydro-1-naphthalenol
Experimental: Rotigotine, low dose Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease	Drug: Rotigotine Rotigotine, transdermal patches: 10 cm2 (2 mg / 24 hours); 20 cm2 (4 mg / 24 hours); 30 cm2 (6 mg / 24 hours); 40 cm2 (8 mg / 24 hours) Optimal dosage: The maximum Rotigotine dose allowed is 8 mg / 24 hours or 16 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours or 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation) Other Name: (6S)-6-propyl-[2 (2 thienyl)ethyl]amino-5,6,7,8-tetrahydro-1-naphthalenol
Placebo Comparator: Placebo Placebo transdermal patches	Other: Placebo Placebo, matching transdermal patches Duration: up to 21 weeks (including de-escalation)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with early or advanced idiopathic Parkinson's Disease
Patients with advanced idiopathic Parkinson's Disease: intake of Levodopa on a stable dose
Unsatisfactory control of Parkinson's Disease motor symptoms under current treatment
Patients experiencing Apathy associated with Parkinson's Disease
Hoehn and Yahr stage score of I to IV
Mini-Mental State Examination score ≥ 25
If an antidepressant drug is taken, the dose must be stable

Exclusion Criteria:

Therapy with a Dopamine agonist
Any medical or psychiatric condition that jeopardizes / compromises patient's ability for participation
Patient has received Neuroleptics, Dopamine releasing substances, Dopamine modulating substances, Alpha-Methyldopa, Metoclopramide, MAO-A inhibitors, Budipine, or Tolcapone
Electroconvulsive therapy
Patient has a
- current/anticipated psychotherapy or behavior therapy
- history of deep brain stimulation
- history of suicide attempt or has suicidal ideation
- impulse control disorder
- severe Depression

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782222

Contacts

Contact: UCB Clinical Trial Call Center

+1 877 822 9493

Locations

United States, Alabama
4320	Recruiting
Birmingham, Alabama, United States
United States, California
4308	Withdrawn
La Jolla, California, United States
4309	Recruiting
Oxnard, California, United States
United States, Florida
4306	Recruiting
Ormond Beach, Florida, United States
4311	Recruiting
Palm Beach Gardens, Florida, United States
4313	Recruiting
Tampa, Florida, United States
United States, Georgia
4314	Recruiting
Decatur, Georgia, United States
United States, Iowa
4322	Recruiting
Des Moines, Iowa, United States
United States, Massachusetts
4326	Recruiting
Springfield, Massachusetts, United States
United States, Mississippi
4330	Recruiting
Ocean Springs, Mississippi, United States
United States, New York
4303	Recruiting
Commack, New York, United States
4317	Recruiting
New York, New York, United States
United States, North Carolina
4319	Recruiting
Asheville, North Carolina, United States
4325	Recruiting
Charlotte, North Carolina, United States
United States, South Carolina
4324	Recruiting
Beaufort, South Carolina, United States
United States, Texas
4305	Recruiting
San Antonio, Texas, United States
Austria
3001	Recruiting
Innsbruck, Austria
3003	Recruiting
Linz, Austria
Slovakia
3801	Recruiting
Banska Bystrica, Slovakia
3806	Recruiting
Krompachy, Slovakia
3807	Recruiting
Zilina, Slovakia
Spain
4001	Recruiting
Barcelona, Spain

Sponsors and Collaborators

UCB BIOSCIENCES GmbH

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB, Inc. ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier:	NCT01782222 History of Changes
Other Study ID Numbers:	PD0005, 2012-002840-26
Study First Received:	January 30, 2013
Last Updated:	April 30, 2013
Health Authority:	Austria: Agency for Health and Food Safety Bulgaria: Bulgarian Drug Agency Croatia: Ministry of Health and Social Care Hungary: National Institute of Pharmacy Italy: Ministry of Health Poland: Ministry of Health Romania: National Medicines Agency Serbia and Montenegro: Agency for Drugs and Medicinal Devices Slovakia: State Institute for Drug Control Slovenia: Agency for Medicinal Products - Ministry of Health Spain: Ministry of Health Turkey: Ministry of Health Ukraine: Ministry of Health United States: Food and Drug Administration

Keywords provided by UCB, Inc.:

Parkinson's Disease
Rotigotine
Apathy

Nonmotor
Motor
Neupro

Additional relevant MeSH terms:

Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

N 0437
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013

Trial to Evaluate The Efficacy Of Rotigotine on Parkinson's Disease-Associated Motor Symptoms And Apathy (BRIGHT)