Clinical trial: Botulinum Toxin A to Treat Arm Tremor (NCT02207946)

Eligibility criteria:
Main Inclusion Criteria:

          -  Diagnosis of 'definite essential tremor' in accordance with modified TRIG criteria, as
             follows:

               -  Bilateral postural tremor with or without kinetic tremor, involving hands and
                  forearms, that is visible and persistent.

               -  It is to be noted that:

               -  Tremor of other body parts may be present in addition to upper limb tremor.

               -  Bilateral tremor may be asymmetric.

               -  Tremor is reported by patient to be persistent, although the amplitude may
                  fluctuate.

          -  First onset of essential tremor at least 6 months before screening with stability of
             the tremor symptoms over 4 weeks and in the opinion of the investigator definite
             diagnosis of essential tremor.

          -  Moderate-to-marked upper-limb postural and/or kinetic tremor at wrist level,
             corresponding to Fahn-Tolosa-Marin upper-limb tremor rating of at least 2 categories
             (scale part C, items 16-23) in the limb to be treated between of 2 or higher.

          -  Visible tremor at wrist level in at least one of the four positions/tasks used in
             kinematic assessments

          -  Tremor deemed by the investigator to require a treatment with 30 - 200 U NT 201 for a
             treatment of up to three joints of the selected upper limb (wrist treatment
             mandatory).

          -  Stable concomitant anti-tremor medication and no clinically relevant findings in
             routine laboratory examinations.

        Main Exclusion Criteria:

          -  Any neurological signs abnormal for the subject's age, other than the tremor itself
             and Froment's maneuver.

          -  Exposure to the following tremorogenic drugs: Lithium, Valproic acid, Amiodarone,
             typical and atypical neuroleptics. Exposure to other than the listed tremorogenic or
             potentially tremorogenic drugs is allowed only if, in the opinion of the investigator,
             this will not interfere with the study drug evaluation. In these cases, a stable
             medication should be reached 4 weeks before screening and intended for the time during
             the study drug evaluation.

          -  Trauma to the central nervous system or the nerves of the target limb within the three
             months preceding the onset of tremor.

          -  Evidence of psychogenic origins of tremor.

          -  Life habits (e.g. smoking, alcohol or substance abuse) prejudicial to study
             participation.

          -  Prior surgery to treat tremor

          -  Recent (16 weeks) treatment with any Botulinum toxin product for any reason.

          -  Relevant recent or planned surgery or other specified relevant treatments and/or
             concomitant disorders.
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.


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