NCT00274131

Brief Summary

To evaluate the efficacy and safety of long-term treatment with pramipexole tablets (BI Sifrol®) in Parkinson's disease (phase III study).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P25-P50 for phase_3 parkinson-disease

Timeline
Completed

Started Dec 1998

Longer than P75 for phase_3 parkinson-disease

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1998

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 10, 2006

Completed
Last Updated

May 21, 2012

Status Verified

May 1, 2012

First QC Date

January 9, 2006

Last Update Submit

May 18, 2012

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • UPDRS Part II (activities of daily living) total score UPDRS Part III (motor examination) total score

Secondary Outcomes (1)

  • UPDRS Part I (mentation, behaviour and mood) total score UPDRS Part IV (complications of therapy) total score UPDRS Part I-III total score UPDRS Part I-IV total score Modified Hoehn and Yahr scale score Global impression of efficacy

Interventions

Pramipexole 0.125 mg tabletsDRUG
Pramipexole 0.5 mg tabletsDRUG

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a diagnosis of Parkinson's disease (including juvenile parkinsonism)
  • Patients of at least 20 years of age
  • In- or outpatients of either sex.
  • Patients in any stage on the modified Hoehn and Yahr severity scale

You may not qualify if:

  • Patients with psychiatric symptoms such as confusion, hallucination, delusion, excitement, delirium, and abnormal behaviour.
  • Patients with subjective symptoms derived from orthostatic hypotension.
  • Patients with hypotension (systolic blood pressure \<100 mmHg)
  • Patients with concomitant illness such as severe cardiac, renal, and hepatic disease
  • Patients with a current or past history of epilepsy
  • Pregnant, possibly pregnant, or lactating women
  • Patients receiving any other investigational products or who have received any other investigational product within 6 months of the study.
  • Patients who judged incompetent to give consent
  • Others judged by the investigator or co-investigator to be ineligible as subjects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

BenzothiazolesThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Boehringer Ingelheim Study Coordinator

    Nippon Boehringer Ingelheim Co., Ltd.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 9, 2006

First Posted

January 10, 2006

Study Start

December 1, 1998

Study Completion

February 1, 2004

Last Updated

May 21, 2012

Record last verified: 2012-05