Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor

• Status: Withdrawn
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pecs
• Treatments: Pramipexole

Criteria

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.)