Safety and Efficacy of Long-term Daily Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01525641
First received: February 1, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

Post-marketing surveillance (PMS) to investigate the safety and efficacy of long-term daily use of Mirapex®-LA Tablets in patients with Parkinson's disease.


Condition Intervention
Parkinson Disease
Drug: Mirapex LA

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Survey on Long-term Drug Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Proportion of adverse drug reactions [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical global impression of effect [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in total score of the UPDRS Part III to last observation [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the Modified Hoehn & Yahr to last observation [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Onset or offset of on and off/wearing-off phenomenon in patients with concomitant L-DOPA [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: February 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patient with Parkinson's Disease Drug: Mirapex LA
Pramipexole Hydrochloride Hydrate

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

600

Criteria

Inclusion criteria:

- Patients with Parkinson's disease who have never been treated with Mirapex LA Tablets before enrolment will be included.

Exclusion criteria:

- None

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525641

  Show 118 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01525641     History of Changes
Other Study ID Numbers: 248.680
Study First Received: February 1, 2012
Last Updated: April 7, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

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 April 17, 2014