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

PHASE4CompletedINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

December 31, 2013

Study Completion Date

January 31, 2014

Conditions
Advanced Idiopathic Parkinson's Disease
Interventions
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.

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.

Trial Locations (16)

Unknown

2113, Gilbert

2120, Sunnyvale

2109, Tampa

2107, Chicago

2102, Lexington

2118, Advance

2117, Cincinnati

2103, Tulsa

2101, Roanoke

2104, Milwaukee

1204, Gera

1607, Gdansk

1603, Krakow

1609, Olsztyn

1804, Bratislava

1805, Dubnica nad Váhom

All Listed Sponsors
lead

UCB BIOSCIENCES GmbH

INDUSTRY

NCT01744496 - Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain | Biotech Hunter | Biotech Hunter