Non-interventional, Retrospective, Multi-center Study to Evaluate Non-motor Symptoms in Advanced Parkinson Disease (PD) Patients Already Treated With Rotigotine

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01504529
• Date of registration: 03/01/2012
• Prospective Registration: No
• Primary sponsor: UCB Pharma
• Public title: Non-interventional, Retrospective, Multi-center Study to Evaluate Non-motor Symptoms in Advanced Parkinson Disease (PD) Patients Already Treated With Rotigotine RETO-PD
• Scientific title: Non-Interventional, Retrospective, Multi-center Study to Evaluate Non-Motor Symptoms in Advanced PD Patients Already Treated With Rotigotine
• Date of first enrolment: September 2011
• Target sample size: 391
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01504529
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Retrospective
• Phase: N/A

Countries of recruitment

Spain

Contacts

• Name: UCB Clinical Trial Call Center
• Affiliation: [phone] (UCB)

Key inclusion & exclusion criteria

Inclusion Criteria:

To be eligible to participate in this study, all of the following criteria must be met:

- Male and female ambulatory patients with Parkinson's disease diagnosis (as per the
London Brain Bank diagnosis criteria) =6 months ago

- Patient aged 30 years or older at the time of Parkinson's disease diagnosis

- Patients who were under treatment with Rotigotine following routine clinical
practice, either alone or in combination with Levodopa, and in an advanced PD dosage
(= 8 mg/ 24 h) for at least the previous 6 months

- Patients under treatment with Rotigotine (= 8 mg/ 24 h) who were assessed twice of
NMS by means of the PDNMS-Q 6 months apart

- Patients are currently informed and have been given enough time and opportunity to
think about participation (data collection) in the study and have given written
informed consent

Exclusion Criteria:

Patients are not permitted to enroll in the study if any of the following criteria is met
during the previous 6 months:

- Patients have other Parkinsonian syndrome different than Parkinson´s disease

- Patients have a history of Pallidotomy, Thalamotomy, Deep Brain Stimulation or Fetal
Tissue Transplant

- Patients with Dementia, active Hallucinations or active or treated Psychosis

- Patients with any other neurological / psychological disorder

- Patients who had received Central Nervous System (CNS) active therapy (e.g.
sedatives, hypnotics, anti-depressants, anxiolytics, atypical neuroleptics, etc)



Age minimum: 30 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Primary Outcome(s)

Change from Baseline to Month 6 in Non-Motor Symptoms (NMS) as assessed by the Parkinson's Disease Non-Motor Symptoms Questionnaire (PDNMS-Q) [Time Frame: From Baseline to Month 6]

Secondary Outcome(s)

Change from Baseline to Month 6 in Hoehn & Yahr stage [Time Frame: From Baseline to Month 6]

Change from Baseline to Month 6 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III [Time Frame: From Baseline to Month 6]

Secondary ID(s)

SP1018

UCB-ROT-2011-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pivotal S.L.