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

Completed

• Conditions: Parkinson's Disease

• Registration Number: NCT01504529
• Lead Sponsor: UCB Pharma

Brief Summary

This is an observational, non-interventional and retrospective study in patients with advanced PD who have been treated with Rotigotine (Neupro®) as prescribed by physicians according to usual clinical practice in Spain.

The Primary Objective will be to evaluate Non-Motor Symptoms (NMS) in advanced PD patients who have been treated with Rotigotine for at least 6 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-01-03
• Study First Submitted QC: 2012-01-04
• Study First Posted: 2012-01-05
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-12
• Last Update Posted: 2013-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 391

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from Baseline to Month 6 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III	From Baseline to Month 6
Change from Baseline to Month 6 in Hoehn & Yahr stage	From Baseline to Month 6

Trial Locations

Locations (59)

65; 🇪🇸 A Coruña, Spain

66; 🇪🇸 A Coruña, Spain

68; 🇪🇸 A Coruña, Spain

33; 🇪🇸 Albacete, Spain

25; 🇪🇸 Alicante, Spain

26; 🇪🇸 Alicante, Spain

27; 🇪🇸 Alicante, Spain

14; 🇪🇸 Avilés, Spain

17; 🇪🇸 Baleares, Spain

42; 🇪🇸 Barcelona, Spain

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