Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain - Full Text View

Purpose

This trial is being conducted to compare the impact of Rotigotine and Placebo on Chronic Pain associated with Parkinson's Disease among patients with advanced stages of the disease.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Multicenter, Multinational, Double-Blind, Placebo-Controlled, 2-Arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain

Resource links provided by NLM:

Genetics Home Reference related topics: Parkinson disease Perry syndrome

MedlinePlus related topics: Anxiety Chronic Pain 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 pain severity assessed using an 11-point Likert Pain Scale [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after an up to 7 weeks Titration Period) ] [ Designated as safety issue: No ]
An 11-Point Likert Scale will be used to assess patients' average daily pain.

Secondary Outcome Measures:

Percentage of Responders at the End of the Maintenance Period [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period) ] [ Designated as safety issue: No ]
Responders are defined as patients experiencing a 2-Point Reduction on an 11-Point Likert Pain Scale from Baseline to the End of the Maintenance Period.
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 (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period) ] [ Designated as safety issue: No ]
Change from Baseline to the End of the Maintenance Period in the combined score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II (Activities of Daily Living [ADL] subscale) and III (motor subscale) [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period) ] [ Designated as safety issue: No ]
Change from Baseline to the End of the Maintenance Period in the Total Score of Classification of Pain in Parkinson's Disease [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period) ] [ Designated as safety issue: No ]
Change from Baseline to the End of the Maintenance Period in the 7-Item Depression subscore of the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period) ] [ Designated as safety issue: No ]
Change from Baseline to the End of the Maintenance Period in the 7-Item Anxiety subscore of the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period) ] [ Designated as safety issue: No ]

Estimated Enrollment:	401
Study Start Date:	November 2012
Estimated Study Completion Date:	March 2015
Estimated Primary Completion Date:	February 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Rotigotine Rotigotine Transdermal Patches	Drug: Rotigotine Patches will contain 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication starts at the Baseline Visit. Rotigotine will be administered once daily starting at 4 mg / 24 h. Doses will then be up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) is reached and the Maintenance Period can be started. The duration of the Titration Period will vary from 1 to 7 weeks ± 3 days. The Maintenance Period will last 12 weeks ± 5 days. Thereafter, during the De-escalation Period, the dose of study medication will be decreased by 2 mg / 24 h every other day. The De-escalation Period may last up to 12 days. Other Name: (6S)-6-propyl-[2 (2 thienyl)ethyl]amino-5,6,7,8-tetrahydro-1-naphthalenol
Placebo Comparator: Placebo Placebo Transdermal Patches	Drug: Placebo Placebo patches match the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and will contain Placebo. Application of Placebo patches starts at the Baseline Visit. Placebo patches will be administered once daily starting with the equivalent of 4 mg / 24 h. Doses will then be up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose is reached. The maximum dose is the equivalent to 16 mg / 24 h. The duration of the Titration Period will vary from 1 to 7 weeks. The Maintenance Period will last 12 weeks ± 5 days. During the De-escalation Period, the dose of Placebo will be decreased by the equivalent to 2 mg / 24 h every other day. The De-escalation Period may last up to 12 days.

Arms

Assigned Interventions

Experimental: Rotigotine

Rotigotine Transdermal Patches

Drug: Rotigotine

Patches will contain 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication starts at the Baseline Visit. Rotigotine will be administered once daily starting at 4 mg / 24 h. Doses will then be up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) is reached and the Maintenance Period can be started. The duration of the Titration Period will vary from 1 to 7 weeks ± 3 days. The Maintenance Period will last 12 weeks ± 5 days. Thereafter, during the De-escalation Period, the dose of study medication will be decreased by 2 mg / 24 h every other day. The De-escalation Period may last up to 12 days.

Other Name: (6S)-6-propyl-[2 (2 thienyl)ethyl]amino-5,6,7,8-tetrahydro-1-naphthalenol

Placebo Comparator: Placebo

Placebo Transdermal Patches

Drug: Placebo

Placebo patches match the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and will contain Placebo. Application of Placebo patches starts at the Baseline Visit. Placebo patches will be administered once daily starting with the equivalent of 4 mg / 24 h. Doses will then be up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose is reached. The maximum dose is the equivalent to 16 mg / 24 h. The duration of the Titration Period will vary from 1 to 7 weeks. The Maintenance Period will last 12 weeks ± 5 days. During the De-escalation Period, the dose of Placebo will be decreased by the equivalent to 2 mg / 24 h every other day. The De-escalation Period may last up to 12 days.

Eligibility

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

Criteria

Inclusion Criteria:

Patient has advanced idiopathic Parkinson's Disease associated chronic pain assessed by a Likert Pain Scale
Patient is taking Levodopa with a stable daily dose of at least 200 mg for at least 21 days prior to start
Hoehn and Yahr stage score of II to IV
Mini-Mental State Examination (MMSE) score ≥ 25
If an antidepressant drug is taken, the dose must be stable for at least 21 days

Exclusion Criteria:

Therapy with a Dopamine Agonist within 21 days prior to start
Discontinuation from previous Dopamine Agonist Therapy due to lack of efficacy
Therapy with Dopamine-modulating substances 21 days prior to start
Therapy with analgesics for the treatment for pain, unless the dose has been stable
Chronic alcohol or drug abuse
Medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the patient's ability to participate in this study
Hypersensitivity to any components of the Investigational Medicinal Product (IMP) or comparative drugs
Atypical Parkinson's Disease Syndrome due to drugs
History of deep brain stimulation
Significant skin disease that would make transdermal drug use inappropriate
Electroconvulsive therapy within 12 weeks prior to start
Evidence of an Impulse Control Disorder
Previous diagnosis of severe Restless Legs Syndrome
Chronic Migraine
Severe Depression
Symptomatic Orthostatic Hypotension

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744496

Contacts

Contact: UCB Clinical Trial Call Center

+ 1 877 822 ext 9493

Show 27 Study Locations

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:	NCT01744496 History of Changes
Other Study ID Numbers:	PD0004, 2012-002608-42
Study First Received:	December 5, 2012
Last Updated:	May 21, 2013
Health Authority:	Argentina: Ministry of Health France: Agence Nationale de Sécurité du Médicament et des produits de santé Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines Hungary: National Institute of Pharmacy Mexico: Federal Commission for Protection Against Health Risks Poland: Ministry of Health Russia: Ministry of Health of the Russian Federation Slovakia: State Institute for Drug Control Ukraine: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration

Keywords provided by UCB, Inc.:

Parkinson's Disease
Rotigotine
Chronic Pain
Nonmotor symptoms

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 June 18, 2013

Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain (DOLORES)