Observational Study in Parkinson's Disease of the Primary Care Population of Patients Treated With Pramipexole

Parkinson Disease Clinical Trial

Official title:

Observational Study in Parkinson's Disease of the Primary Care Population of Patients Treated With Pramipexole by Neurologists in France (ETAP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02236728
• Other study ID #: 248.648
• Status: Completed
• Phase: N/A
• First received: September 10, 2014
• Last updated: September 10, 2014
• Start date: February 2008

Study information

• Verified date: September 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial Summary

The primary objective of this study was to describe neurologists' population of patients treated with pramipexole and suffering from Parkinson's disease (so called 'primary care' population).

The secondary objectives were:

• Evaluate the mean dose of pramipexole prescribed under actual conditions of use depending on the severity of the disease.

• Evaluate the reasons for choosing pramipexole as treatment.

• Identify the patient profiles determining the choice of dose of pramipexole prescribed

Recruitment information / eligibility

• Status: Completed
• Enrollment: 497
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients suffering from idiopathic Parkinson's Disease and treated with pramipexole for at least two months, examined in consultation

Exclusion Criteria:

• Patient refusing to take part

• Patient taking part in a clinical trial

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Pramipexole

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Patient's demographic characteristics		9 months	No
Primary	Assessment of Parkinson's disease characteristics		9 months	No
Secondary	Assessment of Severity of the Parkinson Disease (PD)	(levels of severity of the disease were defined with the scientific committee in 5 stages: treatment initiation phase, honeymoon phase, therapeutic insufficiency phase, start of motor complications phase and advanced motor complications phase)	9 months	No
Secondary	Assessment of Disease Stage Stage according to Hoehn and Yahr and Unified Parkinson Disease Rating Scale III (UPDRS III) scores		9 months	No
Secondary	Description of the actual treatments of PD		9 months	No
Secondary	Evaluation for reasons for choosing pramipexole as treatment		9 months	No
Secondary	Assessment of Treatment history	3 subgroups: Initiation: no antiparkinson treatment before the implementation of pramipexole Switch: at least one dopamine agonist replaced by pramipexole Add on: pramipexole is implemented in addition to the previous treatment	9 months	No
Secondary	Evaluation of the state of health perceived by the patient using the questionnaire EQ-5D		9 months	No
Secondary	Number of patients with adverse events		9 months	No

External Links

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