Status:
WITHDRAWN
Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor
Lead Sponsor:
University of Pecs
Conditions:
Essential Tremor
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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-kine...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01441284
Start Date
December 1 2017
End Date
December 1 2018
Last Update
May 8 2017
Active Locations (2)
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1
Department of Neurology, University of Pécs
Pécs, Baranya, Hungary, H-7623
2
Kaposi Mór County Hospital
Kaposvár, Somogy County, Hungary, H-7400