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

Parkinson's Disease Clinical Trial

— RETO-PD  

Official title:

Non-Interventional, Retrospective, Multi-center Study to Evaluate Non-Motor Symptoms in Advanced PD Patients Already Treated With Rotigotine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01504529
• Other study ID #: SP1018
• Secondary ID: UCB-ROT-2011-01
• Status: Completed
• Phase: N/A
• First received: January 3, 2012
• Last updated: April 12, 2013
• Start date: September 2011
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 391
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
Spain	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	43	Barcelona
Spain	44	Barcelona
Spain	45	Barcelona
Spain	47	Barcelona
Spain	48	Barcelona
Spain	49	Barcelona
Spain	52	Barcelona
Spain	85	Barcelona
Spain	55	Bilbao
Spain	10	Cadiz
Spain	32	Ciudad Real
Spain	34	Cuenca
Spain	53	Gerona
Spain	59	Guipúzcoa
Spain	11	Huesca
Spain	16	Islas Baleares
Spain	3	Jaen
Spain	4	Jaen
Spain	50	Lérida
Spain	69	Lugo
Spain	70	Madrid
Spain	71	Madrid
Spain	73	Madrid
Spain	74	Madrid
Spain	75	Madrid
Spain	76	Madrid
Spain	78	Madrid
Spain	79	Madrid
Spain	80	Madrid
Spain	18	Mao
Spain	15	Mieres
Spain	81	Murcia
Spain	82	Murcia
Spain	83	Navarra
Spain	13	Oviedo
Spain	63	Pontevedra
Spain	67	Pontevedra
Spain	30	Santa Cruz de Tenerife
Spain	38	Segovia
Spain	29	Tenerife
Spain	31	Tenerife
Spain	36	Toledo
Spain	19	Valencia
Spain	20	Valencia
Spain	22	Valencia
Spain	23	Valencia
Spain	24	Valencia
Spain	58	Vera de Bidasoa
Spain	56	Vizcaya

Sponsors (2)

Lead Sponsor	Collaborator
UCB Pharma	Pivotal S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change from Baseline to Month 6 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III		From Baseline to Month 6	No
Secondary	Change from Baseline to Month 6 in Hoehn & Yahr stage		From Baseline to Month 6	No