Clinical trial: A Cross Over Pilot Study of Abobotulinum Toxin A (Dysport) as a Treatment for Task-dependent Upper Limb Tremor (NCT03136341)

Eligibility criteria:
Inclusion Criteria:

          -  Patients with task-dependent essential tremor in upper limb. Tremor is present during
             at least one of the study functional tasks i. pointing task (touch between nose and a
             pen held 2 ft. in front. ii. pouring task (cup: pouring water out/in). iii. feeding
             task (weighted fork from plate on table to mouth). iv. string instrument bowing or
             holding instrument in static position. v. computer mouse (simple vertical or
             horizontal movements).

          -  Patients must be capable of performing informed consent.

          -  Patients on stable medications for treatment of task-dependent essential tremor for 1
             month prior to study entry and maintain them throughout the study.

          -  Patients previously treated with BoNT of any type must have occurred no sooner than 12
             weeks prior to study entry.

        Exclusion Criteria:

          -  Patients with no presence of tremor during study functional tasks.

          -  Presence of tremor during the functional task is below minimum amplitude required to
             be considered for injection based upon investigator's clinical judgment.

          -  Patients with unstable medical conditions or psychiatric conditions.

          -  Patients with a medical condition that precludes them from receiving BoNT injections.

          -  Pregnant women, or premenopausal women not willing to use contraceptive measures
             throughout the duration of the study.

          -  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
             evaluations.
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