Influence of Pramipexole Extended Release on Medication Adherence in Parkinson´s Disease

Boehringer Ingelheim

Status: Completed

Conditions: Parkinson Disease

Treatments: Drug: Pramipexole Extended Release

Study type: Observational

Funder types: Industry

Identifiers

NCT01097421

248.674

Details and patient eligibility

About

This is an open-label, prospective post marketing surveillance study to be performed in Sweden. Only data of patients idiopathic PD should be documented, in whom the treating physician plans to initiate a pharmacotherapy with PPX ER independent of this observational study. The questionnaires (Morisky Medication Adherence Measure, patient preference scale, CGI-I, PGI-I) will be used to document routine care in a standardized way and thus ensure high validity of the observational data. As the degree medication adherence of patients is routinely evaluated by their physicians, as is patient preference and possible symptom improvement after initiation of a new therapy, the patient questionnaires will be used to standardise medical routine care and to ensure validity of observational data.

Enrollment: 329 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients suffering from idiopathic PD who before inclusion into the observation had been planned to be treated with PPX ER according to the SP, and where decision of treatment was made independently of the patients¿ inclusion into this observational study
2. Stable dose of PPX IR for at least 4 weeks before inclusion into the observation
3. Male or female PD patients aged at least 30
4. Ability to reliably complete self-rating scales (Morisky Medication Adherence Measure, patient preference scale) according to the physician¿s judgement
5. Written informed consent by the patient for study participation.

Exclusion criteria

1. Patients who are not able to understand the questionnaires (e.g. due to mental impairment or language problems) according to the physician¿s judgement.
2. Any contraindications against PPX ER according to the Summary of Product Characteristics (SPC).

Trial design

329 participants in 1 patient group

Patient with parkinsons disease

Treatment:

Drug: Pramipexole Extended Release