Trial to Assess Parkinson's Disease (PD) Symptom Control to Four Doses of Rotigotine in a Transdermal Patch

UCB

Status and phase: Completed; Phase 3

Conditions: Parkinson's Disease

Treatments: Drug: Rotigotine; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00522379

SP0921

Details and patient eligibility

About

The purpose of this study is to show Rotigotine dose response at four doses of Rotigotine used with L-dopa in treating advanced stage Parkinson's disease.

Full description

To maintain treatment blind, two different active patch sizes were used (10 cm^2 & 20 cm^2). Placebo patches matched according to size and appearance. During the trial subjects applied up to three patches, active and placebo, to achieve their assigned daily dose.

Enrollment: 514 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• PD greater than 3 years
• Stable dose L-dopa but symptoms not adequately controlled and have "off" time
• Able and willing to complete diary on specific days

Exclusion criteria

• Previous use of rotigotine or Neupro
• Atypical Parkinson's syndrome
• Pallidotomy
• Thalamotomy
• Deep brain stimulation
• Fetal tissue transplant
• Dementia
• Psychosis
• Hallucinations
• Epilepsy
• Renal or hepatic dysfunction
• Clinically relevant cardiac dysfunction
• Symptomatic orthostatic hypotension
• Skin sensitivity to adhesives or unresolved contact dermatitis
• History of chronic alcohol or drug abuse
• Pregnant or of child-bearing potential
• Impulse control disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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514 participants in 5 patient groups, including a placebo group

Rotigotine 2 mg/24 hr

Experimental group

Treatment:

Drug: Rotigotine

Drug: Rotigotine

Drug: Rotigotine

Drug: Rotigotine

Rotigotine 4 mg/24 hr

Experimental group

Treatment:

Drug: Rotigotine

Drug: Rotigotine

Drug: Rotigotine

Drug: Rotigotine

Rotigotine 6 mg/24 hr

Experimental group

Treatment:

Drug: Rotigotine

Drug: Rotigotine

Drug: Rotigotine

Drug: Rotigotine

Rotigotine 8 mg/24 hr

Experimental group

Treatment:

Drug: Rotigotine

Drug: Rotigotine

Drug: Rotigotine

Drug: Rotigotine

Placebo

Placebo Comparator group

Treatment:

Other: Placebo