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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc. ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier:
NCT01782222
First received: January 30, 2013
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Idiopathic Parkinson's Disease
Drug: Rotigotine
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Multinational, Double-Blind, Placebo-Controlled, 3-Arm, Phase 4 Study To Evaluate The Efficacy Of Rotigotine On Parkinson's Disease-Associated Apathy, Motor Symptoms, And Mood

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Change from Baseline to the End of the Maintenance Period in the score of the Apathy Evaluation Scale (AS) rated by the patient [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline) ] [ Designated as safety issue: No ]
  • Change from Baseline to the End of the Maintenance Period in the total score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II (activities of daily living) + III (motor symptoms) [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline to the End of the Maintenance Period in the score of the Apathy Evaluation Scale (AS) rated by the caregiver (where available) [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline) ] [ Designated as safety issue: No ]
  • Change from Baseline to the End of the Maintenance Period in the sum score of the 8-item Parkinson's Disease Questionnaire (PDQ-8) [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline) ] [ Designated as safety issue: No ]
  • Change from Baseline to the End of the Maintenance Period in the sum score of the mood / cognition domain of the Nonmotor Symptom Assessment Scale (NMSS) [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline) ] [ Designated as safety issue: No ]
  • Change from Baseline to the End of the Maintenance Period in the sum score of the Snaith Hamilton Pleasure Scale (SHAPS) [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline) ] [ Designated as safety issue: No ]
  • Change from Baseline to the End of the Maintenance Period in the sum score of the Beck Depression Inventory Second Edition (BDI-II) [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline) ] [ Designated as safety issue: No ]
  • Change from Baseline to the End of the Maintenance Period in the sum score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part III (motor subscale) in "on" state [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline) ] [ Designated as safety issue: No ]
  • Change from Baseline to the End of the Maintenance Period in the score of the Clinical Global Impression Scale (CGI) Item I (Severity of Illness) [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period/Early Withdrawal (up to 19 weeks after Baseline) ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: February 2013
Study Completion Date: March 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rotigotine, high dose
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
Drug: Rotigotine

Rotigotine, transdermal patches:

10 cm2 (2 mg / 24 hours); 20 cm2 (4 mg / 24 hours); 30 cm2 (6 mg / 24 hours); 40 cm2 (8 mg / 24 hours)

Optimal dosage:

The maximum Rotigotine dose allowed is 8 mg / 24 hours or 16 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours or 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)

Other Name: (6S)-6-propyl-[2 (2 thienyl)ethyl]amino-5,6,7,8-tetrahydro-1-naphthalenol
Experimental: Rotigotine, low dose
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
Drug: Rotigotine

Rotigotine, transdermal patches:

10 cm2 (2 mg / 24 hours); 20 cm2 (4 mg / 24 hours); 30 cm2 (6 mg / 24 hours); 40 cm2 (8 mg / 24 hours)

Optimal dosage:

The maximum Rotigotine dose allowed is 8 mg / 24 hours or 16 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours or 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)

Other Name: (6S)-6-propyl-[2 (2 thienyl)ethyl]amino-5,6,7,8-tetrahydro-1-naphthalenol
Placebo Comparator: Placebo
Placebo transdermal patches
Other: Placebo

Placebo, matching transdermal patches

Duration: up to 21 weeks (including de-escalation)


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01782222

  Show 42 Study Locations
Sponsors and Collaborators
UCB BIOSCIENCES GmbH
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc. ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier: NCT01782222     History of Changes
Other Study ID Numbers: PD0005, 2012-002840-26
Study First Received: January 30, 2013
Last Updated: March 5, 2014
Health Authority: Austria: Agency for Health and Food Safety
Bulgaria: Bulgarian Drug Agency
Croatia: Ministry of Health and Social Care
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Poland: Ministry of Health
Romania: National Medicines Agency
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health
Spain: Ministry of Health
Turkey: Ministry of Health
Ukraine: Ministry of Health
United States: Food and Drug Administration

Keywords provided by UCB, Inc.:
Parkinson's Disease
Rotigotine
Apathy
Nonmotor
Motor
Neupro

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
N 0437
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014