NCT01441284

Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor

Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor: a Double-blind, Cross-over, Placebo-controlled Multicenter Study

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Pecs · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Aim of the study is to perform a double-blind, crossover, placebo-controlled multicenter study evaluating the efficacy of pramipexole on essential tremor.

Detailed description

Essential tremor is one of the most common movement disorders with the prevalence of 3-5% among the elderly population. Although its main clinical feature is the bilateral, predominantly postural-kinetic tremor, newer studies suggest that ET is a spectrum of clinical features with both motor and nonmotor elements not homogeneously distributed. Despite its high occurrence, the pharmacological treatment of ET is limited. Although the mainline drugs, propranolol and primidone, can provide good clinical benefit in a portion of cases, \>50% of the patients stop the medication due to inefficacy or side-effects. Hypotension, dizziness, bradycardia, cognitive impairment, fatigue and erectile dysfunction are the most common side-effects contributing to medication discontinuation. In an open-label pilot study, the investigators previously demonstrated that 2.1 mg/day pramipexole extended-release improved both the severity of tremor (by 52%) and health-related quality of life. The present study aims to confirm this hypothesis in a double-blind, crossover, placebo-controlled multicenter study.

Conditions

• Essential Tremor

Interventions

Type	Name	Description
DRUG	pramipexole	pramipexole extended release, 2.1 mg pramipexole base (3.0mg pramipexole salt) once daily
DRUG	placebo	placebo

Timeline

• Start date: 2017-12-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2011-09-27
• Last updated: 2017-05-08

Locations

2 sites across 1 country: Hungary