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 identification

• EU PAS number:
  EUPAS4714
• Study ID:
  6157
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Korea, Republic of

  Malaysia

  Singapore

  Taiwan
• Study description:
  This study is 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

401, Sydney, Australia
402, Chatswood, New South Wales, Australia
404, Darlinghurst, New South Wales, Australia
403, Melbourne, Victoria, Australia
104, 112, 109, 111, Busan, Busan, Daegu, Gyeonggi-Do; Korea, Republic of
110, 101, 102, 103, 105, 107, 108, 106, Seoul; Korea, Republic of
202, 204, 201, Kuala Terengganu, Kuching Sarawak, Pulau Pinang; Malaysia
501, 502, Singapore; Singapore
302, 303, 306, Taichung, Tainan, Taipei; Taiwan

Study timelines

Date when funding contract was signed

Actual:01/06/2012

Study start date

Actual:19/10/2012

Date of final study report

Planned:30/11/2013

Actual:13/12/2013

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

UCB BIOSCIENCES GmbH, Otsuka Pharmaceutical Co., Ltd.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable