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Post Marketing Surveillance of Mirapex LA on the Long-term Use

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01525641
First received: February 1, 2012
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
  Purpose

In Japan, post-approval execution of post-marketing surveillance (PMS) is requested by the Japanese Pharmaceutical Affairs Law (J-PAL) in order to accumulate safety and efficacy data for re-examination. Reexamination period is defined by the J-PAL Four years after approval of new dosage form, results of PMS need to be submitted as a part of re-examination dossier to the Japanese regulatory authority, the Ministry of Health, Labour and Welfare.


Condition Intervention
Parkinson Disease
 Drug: Mirapex LA

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Proportion of adverse drug reactions [ Time Frame: up to 52 weeks ] [ Designated as safety issue: Yes ]
  • Proportion of serious adverse events [ Time Frame: up to 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical global impression of effect [ Time Frame: up to 52 weeks ]
  • Change from baseline in total score of the UPDRS Part III to last observation [ Time Frame: up to 52 weeks ]
  • Change from baseline in the Modified Hoehn & Yahr to last observation [ Time Frame: up to 52 weeks ]
  • Proportion of following AEs of special interest -Sudden onset of sleep -Somnolence -Neuroleptic malignant syndrome -Hallucination -Delusion -Delirium -Agitation -Confusion -Dyspepsia -Dry mouth -Constipation -Vomiting -Abnormal behaviour [ Time Frame: up to 52 weeks ] [ Designated as safety issue: Yes ]
  • 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: Yes ]

Estimated Enrollment: 600
Study Start Date: February 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 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 Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01525641     History of Changes
Other Study ID Numbers: 248.680
Study First Received: February 1, 2012
Last Updated: May 2, 2013
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 May 21, 2013