Clinical trial: A Pilot Clinical Trial Of Memantine for Essential Tremor (NCT00439699)

Eligibility criteria:
Inclusion Criteria:

          -  Age 18 or older

          -  Subject diagnosed with essential tremor affecting both upper extremities.

          -  Subject has been diagnosed for at least one year with tremor that is troublesome, so
             that improvement of tremor would improve the quality of life.

          -  Subject has tremor with a tremor rating scale severity of 2 to 4 in one or both upper
             extremities in the tremor rating scale during posture and/or kinesis.

          -  Subject has not had satisfactory tremor response to at least one anti-tremor
             medication.

          -  Subject is able to comply with all testing and follow-up visit requirements.

          -  Subject is able to abstain from alcohol for at least 12 hours prior to each Study
             Visit and from caffeinated beverages on the day of the Visit.

          -  Subject has voluntarily signed an informed consent in accordance with institutional
             policies.

          -  Subject is either

               -  Not taking medication for Essential Tremor and has not done so for at least 28
                  days prior to Visit 1.

               -  Taking medication for Essential Tremor and has been taking a stable dose so for
                  at least 28 days prior to Visit 1.

        Exclusion Criteria:

          -  Subject has progressive neurological disease other than Essential Tremor.

          -  Subject has history of alcoholism or drug abuse within the past year.

          -  Subject has history of mania, bipolar depressive disorder, schizophrenia, or other
             major psychiatric disorder.

          -  Subject drinks more than 2 glasses of wine or equivalent per day in last 30 days.

          -  Subject has received botulinum injection of the upper extremities in the past 6
             months.

          -  Subject is currently using investigational device.

          -  Subject has taken an investigational drug within a clearance duration of 5 times the
             half-life of the investigational drug.

          -  Subject is pregnant or a female of childbearing potential not using adequate
             contraception.

          -  Subject has a medical condition likely to result in hospitalization.

          -  Known allergy to memantine or amantadine.

          -  Taking medication that alkalinizes the urine, such as carbonic anhydrase inhibitor or
             sodium bicarbonate.

          -  Any disorder or condition that may interfere with the absorption, the distribution, or
             excretion of drugs.

          -  Taking medication known to cause postural tremor, that in the clinical judgement of
             the investigator is contributing to the subject's tremor.

          -  Receiving deep brain stimulation within two weeks prior to Visit 1 or has potential
             need for deep brain stimulation during the study.

          -  Has received ablative thalamotomy or gamma knife thalamotomy within six months of
             study onset.

          -  Tremor potentially due to head trauma, hyperthyroidism, cerebrovascular disease,
             multiple sclerosis, polyneuropathy, or family history of Fragile X syndrome.

          -  Known renal disease with creatinine level outside normal range.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
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