Non-interventional Observational Study With Pramipexole: Impact on Non-motor Symptoms in Parkinson's Disease
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00539214
First received: September 28, 2007
Last updated: June 21, 2012
Last verified: June 2012
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Purpose
In this German non-interventional observational study 1755 patients diagnosed with Parkinson¿s disease (PD) will be investigated by 585 specialists (neurologists or neurologist and psychiatrists) across Germany.
Both early and advanced PD patients with or without previous antiparkinsonian treatment are eligible for this study, if it is planned to initiate a new therapy with pramipexole or to switch to pramipexole from a previously given, insufficient dopamine agonist therapy.
Only marketed substance of Sifrol® will be used throughout the study. Sifrol treatment will be started and uptitrated as per Summary of Product Characteristics (SPC). Three visits are planned to be documented in this PMS study within a total observation period of 9-16 weeks. Evaluations and visits are to be carried out and documented only if part of routine medical practice.
The objectives of this study are:
To compare the effect of pramipexole on depressive symptoms in early and advanced PD patients To evaluate the course of depressive symptoms measured with UPDRS Part I (mentation, behavior and mood) and with HADS-D under pramipexole treatment.
To investigate whether improvement of depressive symptoms is linked to improvement in motor function (UPDRS Part III).
| Condition |
|---|
|
Parkinson Disease |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Observational Non-interventional Study on Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Course of depressive symptoms under pramipexole treatment. [ Time Frame: 9-16 weeks ]
Secondary Outcome Measures:
- No defined secondary endpoints. [ Time Frame: 9-16 weeks ]
| Enrollment: | 1187 |
| Study Start Date: | March 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Study Design:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
PD patients
Criteria
Inclusion criteria:
- Idiopathic Parkinsons disease with or without fluctuations
- Indication for treatment with Sifrol®
- Male or female patients of age
- Presence of at least mild depressive symptoms (as judged by the treating physician)
- Ability to reliably complete a self-rating scale (HADS)
Exclusion criteria:
- Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients.
- Ongoing treatment with Sifrol®.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00539214
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Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00539214 History of Changes |
| Other Study ID Numbers: | 248.639 |
| Study First Received: | September 28, 2007 |
| Last Updated: | June 21, 2012 |
| Health Authority: | Germany: BfArM (Bundesinstitut für Arzneimittel und Medizinalprodukte |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Pramipexol Antioxidants Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Protective Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Dopamine Agonists Dopamine Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on May 23, 2013