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A 12-week Study of Pramipexole ER in Patients With Parkinson's Disease, Followed by a 52-week Long-term Treatment Period

11:28 EDT 17th April 2014 | BioPortfolio

Summary

The objective of this trial is to investigate the safety, tolerability, trough plasma concentration, and efficacy of pramipexole ER in comparison with those of pramipexole IR administrated orally for 12 weeks in patients with PD on L-DOPA therapy (the double-blind period). The double-blind period will be followed by the open-label 52 week administration of pramipexole ER to evaluate the long term safety and efficacy (the open-label period).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Conditions

Parkinson Disease

Intervention

Placebo, Placebo, Pramipexol Extended Release, Pramipexole Immediate Release

Location

248.610.019 Boehringer Ingelheim Investigational Site
Akashi, Hyogo
Japan

Status

Completed

Source

Boehringer Ingelheim Pharmaceuticals

Results (where available)

View Results

Links

Medical and Biotech [MESH] Definitions

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

A hypothalamic tripeptide, enzymatic degradation product of OXYTOCIN, that inhibits the release of MELANOCYTE-STIMULATING HORMONES.

A stable, physiologically active compound formed in vivo from the prostaglandin endoperoxides. It is important in the platelet-release reaction (release of ADP and serotonin).

Uncontrolled release of biological material from its containment. This either threatens to, or does, cause exposure to a biological hazard. Such an incident may occur accidentally or deliberately.

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