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

NCT01744496 | Completed Phase 4 Results

• 2 other identifiers: PD00042012-002608-42
• Study Type: interventional
• Target: 68
• Locations: 4 countries
• Sites: 16

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

Keywords

Parkinson's Disease; Rotigotine; Chronic Pain; Nonmotor symptoms

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to the End of the Maintenance Period in Pain Severity Assessed Using an 11-point Likert Pain Scale

  An 11-Point Likert Scale was used to assess patients' average daily pain. The subject rated his/her average pain from 0 (no pain) to 10 (worst pain ever experienced). The average pain experienced in the last 7 days was calculated by the mean of the daily Likert Pain Scores within the 7 days prior to the respective visit (ie, Likert Pain Scores with a date of assessment before the date of visit and on or after the date of visit - 7 days). A negative value indicates an improvement.

  Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after an up to 7 weeks Titration Period)

Secondary Outcomes (6)

• Percentage of Responders at the End of the Maintenance Period

  Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration 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)

  Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)

• Change From Baseline to the End of the Maintenance Period in the 7-Item Depression Subscore of the Hospital Anxiety and Depression Scale (HADS)

  Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)

• Change From Baseline to the End of the Maintenance Period in the 7-Item Anxiety Subscore of the Hospital Anxiety and Depression Scale (HADS)

  Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)

• 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)

  Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)

Study Arms (2)

Rotigotine

EXPERIMENTAL

Rotigotine Transdermal Patches

Drug: Rotigotine

Placebo

PLACEBO COMPARATOR

Placebo Transdermal Patches

Drug: Placebo

Interventions

Rotigotine 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.

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

Rotigotine

Placebo 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.

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB BIOSCIENCES GmbH: lead

Study Sites (16)

2113

Gilbert, Arizona, United States

Location

2120

Sunnyvale, California, United States

Location

2109

Tampa, Florida, United States

Location

2107

Chicago, Illinois, United States

Location

2102

Lexington, Kentucky, United States

Location

2118

Advance, North Carolina, United States

Location

2117

Cincinnati, Ohio, United States

Location

2103

Tulsa, Oklahoma, United States

Location

2101

Roanoke, Virginia, United States

Location

2104

Milwaukee, Wisconsin, United States

Location

1204

Gera, Germany

Location

1607

Gdansk, Poland

Location

1603

Krakow, Poland

Location

1609

Olsztyn, Poland

Location

1804

Bratislava, Slovakia

Location

1805

Dubnica nad Váhom, Slovakia

Location

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Parkinson Disease; Chronic Pain

Interventions

rotigotine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

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

+1 877 822 9493

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2012
• First Posted: December 6, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: May 1, 2015
• Results First Posted: December 2, 2014

Record last verified: 2015-04

Locations

DE (1); PL (3); SL (2); US (10)