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

NCT ID: NCT01744496

Last Updated: 2015-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-01-31

Brief Summary

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.

Conditions

Advanced Idiopathic Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Rotigotine

Rotigotine Transdermal Patches

Group Type: EXPERIMENTAL

Rotigotine

Intervention Type: DRUG

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.

Placebo

Placebo Transdermal Patches

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

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

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB BIOSCIENCES GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

2113

Gilbert, Arizona, United States

2120

Sunnyvale, California, United States

2109

Tampa, Florida, United States

2107

Chicago, Illinois, United States

2102

Lexington, Kentucky, United States

2118

Advance, North Carolina, United States

2117

Cincinnati, Ohio, United States

2103

Tulsa, Oklahoma, United States

2101

Roanoke, Virginia, United States

2104

Milwaukee, Wisconsin, United States

1204

Gera, , Germany

1607

Gdansk, , Poland

1603

Krakow, , Poland

1609

Olsztyn, , Poland

1804

Bratislava, , Slovakia

1805

Dubnica nad Váhom, , Slovakia

Countries

United States; Germany; Poland; Slovakia

Related Links

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

2012-002608-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PD0004

Identifier Type: -

Identifier Source: org_study_id