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Essential Tremor | Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor

Essential Tremor research study

What is the primary objective of this study?

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

Who is eligible to participate?

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: - Exclusion criteria are established in accordance to the guidelines of Elble et al3. - Presence of any medical conditions capable of producing tremor (e.g. hyperthyroidism, drug withdrawal, neuropathy, etc.). - Except for cogwheel phenomenon, the presence of any abnormal neurological signs (e.g. dystonia, myoclonus, ataxia, parkinsonism, cerebellar or pyramidal signs, etc.) - Atypical tremor appearance for ET (e.g. isolated vocal-cord tremor, orthostatic tremor, task-specific tremor, etc.) - Presence or suspicion of psychogenic tremor - Usage of medication capable of producing tremor (e.g. sympathomimetics, valproate, etc.) - Concomitant administration of any drugs potentially capable of improving ET (e.g. antiepileptics, beta-receptor blockers). - Previous neurosurgical treatment (e.g. deep brain stimulation or thalamotomy). - Presence of serious concomitant disorders capable of interfering with the study (e.g. heart failure, tumorous disorders, etc.) - Presence of any contraindication for pramipexole treatment (e.g. impulsive control disorder, known hypersensitivity to any components of the tablets, etc.)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Essential Tremor

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

Drug:placeboplacebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Process 110 weeks of pramipexole treatment 2 weeks wash-out period (cross-over) 10 weeks placebo treatment

Process 210 weeks of placebo treatment 2 weeks wash-out period (cross-over) 10 weeks pramipexole treatment

Study Status

Withdrawn

Start Date: December 2017

Completed Date: December 2018

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Improvement in tremor severity

Secondary Outcome: Improvement in quality of life

Study sponsors, principal investigator, and references

Principal Investigator: Norbert Kovacs, MD, PhD

Lead Sponsor: University of Pecs

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01441284

Kovács N, Pál E, Késmárky I, Komoly S, Nagy F, Herceg M. Pramipexole for treating essential tremor. Eur J Neurol 2011;18(Suppl 2):482.

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