Trial record 6 of 1389 for:    Parkinson's Disease

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 Pharma ( 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 Pharma:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Pharma ( 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 Pharma:
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 September 30, 2014