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

NCT01097421 | Completed Results

• 1 other identifier: 248.674
• Study Type: observational
• Target: 329
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment

  Morisky scale: 4 Yes/No Questions: Do you ever forget to take your medicine? Are you careless at times about taking your medicine? When you feel better do you sometimes stop taking your medicine? Sometimes if you feel worse when you take the medicine, do you stop taking it? Score one point for every NO: 0-1 points = low adherence, 2-3 points = moderate, 4 points = high adherence Confidence interval computed using the Clopper-Pearson (exact) method.

  8-12 weeks

• Level of Adherence

  Points on Morisky scale

  8-12 weeks

Secondary Outcomes (5)

• Patient Preference

  8-12 weeks

• Adverse Events (AE) Considered Related to Observed Medication

  8-12 weeks

• Pramipexole (PPX) Dose

  pre-treatment and after 8-12 weeks

• Clinical Global Impressions (CGI)

  8-12 weeks

• Patients Global Impressions (PGI)

  8-12 weeks

Study Arms (1)

Patient with parkinsons disease

Drug: Pramipexole Extended Release

Interventions

Pramipexole Extended Release DRUG

Patient with parkinsons disease

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

specialist care

You may qualify if:

• Male or female PD patients aged at least 30
• Ability to reliably complete self-rating scales (Morisky Medication Adherence Measure, patient preference scale) according to the physician¿s judgement
• Written informed consent by the patient for study participation.

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2010
• First Posted: April 1, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2011
• Last Updated: April 11, 2014
• Results First Posted: November 26, 2012

Record last verified: 2014-03