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

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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

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

Trial contacts and locations

42

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Data sourced from clinicaltrials.gov

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