Trial to Evaluate The Efficacy Of Rotigotine on Parkinson's Disease-Associated Motor Symptoms And Apathy (BRIGHT)

UCB

Status and phase: Completed; Phase 4

Conditions: Idiopathic Parkinson's Disease

Treatments: Other: Placebo; Drug: Rotigotine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01782222

2012-002840-26 (EudraCT Number)

PD0005

Details and patient eligibility

About

This trial is being conducted to assess the effects of Rotigotine over Placebo on improvement of Apathy and motor symptoms in subjects with early-stage and advanced stage idiopathic Parkinson´s Disease.

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with early or advanced idiopathic Parkinson's Disease
• Patients with advanced idiopathic Parkinson's Disease: intake of Levodopa on a stable dose of at least 200 mg/day
• Unsatisfactory control of Parkinson's Disease motor symptoms under current treatment
• Patients experiencing Apathy associated with Parkinson's Disease
• Hoehn and Yahr stage score of I to IV
• Mini-Mental State Examination score ≥ 25
• If an antidepressant drug is taken, the dose must be stable

Exclusion criteria

• Therapy with a Dopamine agonist

• Discontinuation from pervious therapy with a dopamine agonist after an adequate length of treatment, at adequate dose, due to lack of efficacy

• Any medical or psychiatric condition that jeopardizes / compromises patient's ability for participation

• Patient has received Neuroleptics, Dopamine releasing substances, Dopamine modulating substances, Alpha-Methyldopa, Metoclopramide, MAO-A inhibitors, Budipine, or Tolcapone

• Electroconvulsive therapy

• Patient has a

  • current/anticipated psychotherapy or behavior therapy
  • history of deep brain stimulation
  • history of suicide attempt or has suicidal ideation
  • impulse control disorder
  • severe Depression

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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122 participants in 3 patient groups, including a placebo group

Rotigotine, high dose

Experimental group

Description:

Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease

Treatment:

Drug: Rotigotine

Rotigotine, low dose

Experimental group

Description:

Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease

Treatment:

Drug: Rotigotine

Placebo

Placebo Comparator group

Description:

Placebo transdermal patches

Treatment:

Other: Placebo