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Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01441284

Enrollment

Registered

2011-09-27

Start date

2017-12-31

Completion date

2018-12-31

Last updated

2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Tremor

Keywords

pramipexole, essential tremor, cross-over

Brief 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.

Interventions

DRUGpramipexole

pramipexole extended release, 2.1 mg pramipexole base (3.0mg pramipexole salt) once daily

DRUGplacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Diagnosis of ET has to be unambiguous based on the clinical diagnostic criteria. * Tremor has to be severe enough to produce disability. * Patients must sign a written informed consent according with the approval of the Regional Ethical Board of University of Pécs

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Improvement in tremor severity	10 weeks of treatment	Improvement in tremor severity measured by Fahn-Tolosa-Marin Tremor Rating Scale

Secondary

Measure	Time frame	Description
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	10 weeks of treatment	—
Improvement in quality of life	10 weeks of treatment	Improvement in quality of life assessed by EQ-5D score

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026