An Open-Label Study to Investigate the Safety and Efficacy of Rotigotine Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease Phase 3B

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Clinical trial
• If ‘other’, further details on the scope of the study:
  Safety/Efficacy

Clinical trials

• Clinical trial regulatory scope:
  Pre-authorisation clinical trial
• Clinical trial phase:
  Therapeutic confirmatory (Phase III)
• Clinical trial types:
  Single-arm trial

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N04BC09) rotigotine

  rotigotine
• Additional medical condition(s):
  Advanced Parkinson’s Disease

Population studied

• Short description of the study population:
  Patients with advanced-stage Advanced Parkinson's Disease who have insufficient response to L-dopa and low doses dopamine receptor agonists
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with advanced-stage Parkinson’s Disease (PD)
• Estimated number of subjects:
  90

Study design details

• Main study objective:
  To investigate the safety and efficacy of rotigotine add-on therapy with low doses of pramipexole or ropinirole in patients with advanced-stage Parkinson’s disease (PD) who have insufficient response to L-dopa and low doses dopamine receptor agonists.
• Outcomes:
  Clinical Global Impression Item 4 at the end of Treatment PeriodChange from Baseline to end of Treatment Period in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III ("on" state) total scoreChange from Baseline to end of Treatment Period in the UPDRS Part II (average of "on" and "off" state) total scoreChange from Baseline to end of Treatment Period in absolute time spent "off", Change from Baseline to end of Treatment Period in time spent "on" without troublesome DyskinesiaChange from Baseline to end of Treatment Period in Parkinson's Disease Sleep Scale 2 (PDSS-2) total scoreChange from Baseline to end of Treatment Period in the Pittsburgh Sleep Quality Index (PSQI) global score
• Data analysis plan:
  Descriptive statistics to evaluate the safety of rotigotine add-on therapy with low doses of pramipexole or ropinirole.