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NCT00144300

A Two Year Open Label, Randomized, Parallel Group, Blinded Assessment Ophthalmologic Safety Study of Pramipexole IR Versus Ropinirole in Early Parkinson's Disease Patients

Completed Phase 4 Results posted Last updated 17 February 2014
What this trial tests

Phase 4 trial testing Mirapex in Parkinson Disease in 246 participants. Completed.

Timeline
1 January 2005
Primary endpoint
1 September 2010

Quick facts

Lead sponsorBoehringer Ingelheim
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposediagnostic
Enrollment246
Start date1 January 2005
Primary completion1 September 2010
Sites21 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

30 and older, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

To determine if there is any difference in the presence of retinal deterioration in PD patients treated with pramipexole IR versus ropinirole as monitored by comprehensive ophthalmologic assessments from baseline to the end of study at two years.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The retina as an early biomarker of neurodegeneration in a rotenone-induced model of Parkinson's disease: evidence for a neuroprotective effect of rosiglitazone in the eye and brain.
    Normando EM, Davis BM, De Groef L, Nizari S, et al · · 2016 · cited 75× · PMID 27535749 · DOI 10.1186/s40478-016-0346-z
  2. Ophthalmologic Baseline Characteristics and 2-Year Ophthalmologic Safety Profile of Pramipexole IR Compared with Ropinirole IR in Patients with Early Parkinson's Disease.
    Seiple W, Jennings D, Rosen RB, Borchert L, et al · · 2016 · cited 3× · PMID 28078162 · DOI 10.1155/2016/8298503

Verify or expand the search:

Other recruiting trials for Parkinson Disease

Currently open trials in the same condition.

Other Boehringer Ingelheim trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00144300.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing