Clinical trial NCT01782222: Trial to Evaluate The Efficacy Of Rotigotine on Parkinson's Disease-Associated Motor Symptoms And Apathy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Idiopathic Parkinson's Disease
Keywords: Parkinson's Disease
Rotigotine
Apathy
Nonmotor
Motor
Neupro
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2013-02-01
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline to the End of the Maintenance Period in the Score of the Apathy Evaluation Scale (AS) Rated by the Patient
timeFrame: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)
measure: 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)
timeFrame: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)
Secondary outcomes:
measure: 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)
timeFrame: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)
measure: Change From Baseline to the End of the Maintenance Period in the Sum Score of the 8-item Parkinson's Disease Questionnaire (PDQ-8)
timeFrame: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)
measure: 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)
timeFrame: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)
measure: Change From Baseline to the End of the Maintenance Period in the Sum Score of the Snaith Hamilton Pleasure Scale (SHAPS)
timeFrame: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)
measure: Change From Baseline to the End of the Maintenance Period in the Sum Score of the Beck Depression Inventory Second Edition (BDI-II)
timeFrame: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)
measure: 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
timeFrame: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)
measure: 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)
timeFrame: Baseline (Visit 2) until End of the Maintenance Period/Early Withdrawal (up to 19 weeks after Baseline)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 4320
state: Alabama
city: Oxnard
country: United States
facility: 4309
state: California
city: Ormond Beach
country: United States
facility: 4306
state: Florida
city: Palm Beach Gardens
country: United States
facility: 4311
state: Florida
city: Tampa
country: United States
facility: 4313
state: Florida
city: Decatur
country: United States
facility: 4314
state: Georgia
city: Chicago
country: United States
facility: 4318
state: Illinois
city: Winfield
country: United States
facility: 4316
state: Illinois
city: Des Moines
country: United States
facility: 4322
state: Iowa
city: Kansas City
country: United States
facility: 4304
state: Kansas
city: Springfield
country: United States
facility: 4326
state: Massachusetts
city: Ocean Springs
country: United States
facility: 4330
state: Mississippi
city: Las Vegas
country: United States
facility: 4302
state: Nevada
city: Commack
country: United States
facility: 4303
state: New York
city: New York
country: United States
facility: 4317
state: New York
city: New York
country: United States
facility: 4323
state: New York
city: Asheville
country: United States
facility: 4319
state: North Carolina
city: Charlotte
country: United States
facility: 4325
state: North Carolina
city: Akron
country: United States
facility: 4329
state: Ohio
city: Cincinnati
country: United States
facility: 4312
state: Ohio
city: Beaufort
country: United States
facility: 4324
state: South Carolina
city: Charleston
country: United States
facility: 4332
state: South Carolina
city: San Antonio
country: United States
facility: 4305
state: Texas
city: Salt Lake City
country: United States
facility: 4307
state: Utah
city: Virginia Beach
country: United States
facility: 4333
state: Virginia
city: Innsbruck
country: Austria
facility: 3001
city: Linz
country: Austria
facility: 3003
city: Budapest
country: Hungary
facility: 3301
city: Debrecen
country: Hungary
facility: 3302
city: Gdansk
country: Poland
facility: 3509
city: Gdynia
country: Poland
facility: 3506
city: Poznan
country: Poland
facility: 3504
city: Banska Bystrica
country: Slovakia
facility: 3801
city: Bratislava
country: Slovakia
facility: 3805
city: Krompachy
country: Slovakia
facility: 3806
city: Zilina
country: Slovakia
facility: 3807
city: Ljubljana
country: Slovenia
facility: 3901
city: Barcelona
country: Spain
facility: 4001
city: Barcelona
country: Spain
facility: 4006
city: Oviedo
country: Spain
facility: 4009
city: Sevilla
country: Spain
facility: 4005
city: Sevilla
country: Spain
facility: 4010
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Hauser RA, Slawek J, Barone P, Dohin E, Surmann E, Asgharnejad M, Bauer L. Evaluation of rotigotine transdermal patch for the treatment of apathy and motor symptoms in Parkinson's disease. BMC Neurol. 2016 Jun 7;16:90. doi: 10.1186/s12883-016-0610-7.