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Phase 4 N=122 Randomized Quadruple-blind Treatment

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

Idiopathic Parkinson's Disease

Bottom Line

View on ClinicalTrials.gov: NCT01782222 ↗
Enrolled (actual)
122
Serious AEs
5.7%
Results posted
Jan 2015
Primary outcome: Primary: Change From Baseline to the End of the Maintenance Period in the Score of the Apathy Evaluation Scale (AS) Rated by the Patient — -4.4; -4.6; -4.9 scores on a scale — p=0.977

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Rotigotine (Drug); Placebo (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
UCB BIOSCIENCES GmbH
Primary completion
Jan 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline to the End of the Maintenance Period in the Score of the Apathy Evaluation Scale (AS) Rated by the Patient		 -4.4; -4.6; -4.9 0.977
PRIMARY
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)		 -4.8; -12.4; -10.7 0.005 sig
SECONDARY
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)		 -1.5; -4.8; -5.5 0.200
SECONDARY
Change From Baseline to the End of the Maintenance Period in the Sum Score of the 8-item Parkinson's Disease Questionnaire (PDQ-8)		 -3.8; -5.1; -10.0 0.519
SECONDARY
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)		 -4.6; -9.8; -9.8 0.060
SECONDARY
Change From Baseline to the End of the Maintenance Period in the Sum Score of the Snaith Hamilton Pleasure Scale (SHAPS)		 -0.5; -1.3; -0.9 0.334
SECONDARY
Change From Baseline to the End of the Maintenance Period in the Sum Score of the Beck Depression Inventory Second Edition (BDI-II)		 -3.3; -2.9; -3.7 0.899
SECONDARY
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		 -3.4; -8.9; -8.1 0.014 sig
SECONDARY
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)		 1; 1; 2; 6; 2; 3 —

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01782222). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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