Clinical trial: Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor (NCT01441284)

Eligibility 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.)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago.  It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol.  Family history is significant for similar problems in his mother.  Vital signs are normal and the patient has no other medical conditions.  Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed.

Patient description (patient's own words): I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor.

Does the patient match the trial criteria? Entailment