Clinical trial: 123I-ALTROPANE® Reference Image Acquisition in Subjects With Diagnostically Uncertain Tremor (NCT00596908)

Eligibility criteria:
Inclusion Criteria:

          1. Subjects must provide written informed consent prior to the initiation of any study
             related procedures;

          2. Subjects ≥ 40 years of age;

          3. Subjects with upper extremity tremor for < 2 years duration.

        Exclusion Criteria:

          1. Any clinically significant acute or unstable physical or psychological illness based
             on medical history or physical examination at Visit 1, as determined by the Principal
             Investigator;

          2. Any unexpected clinically significant abnormal laboratory or ECG results obtained at
             Visit 1 and as determined by the Principal Investigator;

          3. Any history of drug, narcotic, or alcohol abuse within 2 years prior to the date of
             informed consent, as defined by the Diagnostic and Statistical Manual of the American
             Psychiatric Association, 4th Edition (DSM-IVR {American Psychiatric Association, 1994
             #2});

          4. Positive urine drug screen at Visit 1;

          5. Participation in an investigational drug or device clinical trial within 30 days prior
             to the date of informed consent;

          6. Previous participation in any 123I-ALTROPANE® trial;

          7. Any exposure to radiopharmaceuticals within 30 days prior to the date of informed
             consent;

          8. Positive (+) pregnancy test at Visit 1 and/or Visit 2;

          9. Breast-feeding;

         10. Inability to lie supine for 1 hour;

         11. Any significant active thyroid disease;

         12. Known sensitivity or allergy to Iodine or Iodine containing products;

         13. A history of repeated head injury or sustained severe head injury in year prior to
             onset of tremor;

         14. A definitive diagnosis of encephalitis;

         15. Any uncontrolled hypertension or diabetes;

         16. Any history of cerebrovascular disease;

         17. Previous evaluation by a Movement Disorder Specialist (MDS);

         18. Treatment within the previous six (6) months prior to informed consent with bupropion,
             metoclopramide, cinnarizine, flunarizine, methylphenidate, reserpine, modafinil, alpha
             methyldopa, amphetamine, or any anti-psychotic medication;

         19. Any treatment with anti-Parkinson's drugs or anti-tremor medications within three (3)
             months prior to the date of the subject signing the informed consent;

         20. Any new prescription or change in dose of medications for chronic conditions within
             four (4) weeks of Visit 2.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 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