123I-ALTROPANE® Reference Image Acquisition in Subjects With Diagnostically Uncertain Tremor

Completed

Conditions studied: Upper Extremity Tremor

In brief

This study is designed to obtain an imaging training set that will be used to evaluate images in future trials. Currently, no radiopharmaceutical diagnostic imaging agent has been approved by the FDA in the U.S. for use in diagnosing Parkinson disease and related Parkinsonian syndromes. The diagnosis of Parkinsonian syndromes in the U.S. is based on clinical criteria only. The goal is to demonstrate that 123I-ALTROPANE® paired with SPECT imaging permits a more accurate early diagnosis of Parkinson disease than a clinical diagnosis by a general neurologist.

Key facts

Study ID

NCT00596908

Run by

Alseres Pharmaceuticals, Inc

People needed

54

Starts

2007-12-01

Expected to finish

2009-03-01

Last updated by the study team

2009-05-29

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must provide written informed consent prior to the initiation of any study related procedures;
• Subjects ≥ 40 years of age;
• Subjects with upper extremity tremor for < 2 years duration.

You may not qualify if…

• 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;
• Any unexpected clinically significant abnormal laboratory or ECG results obtained at Visit 1 and as determined by the Principal Investigator;
• 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});
• Positive urine drug screen at Visit 1;
• Participation in an investigational drug or device clinical trial within 30 days prior to the date of informed consent;
• Previous participation in any 123I-ALTROPANE® trial;
• Any exposure to radiopharmaceuticals within 30 days prior to the date of informed consent;
• Positive (+) pregnancy test at Visit 1 and/or Visit 2;
• Breast-feeding;
• Inability to lie supine for 1 hour;
• Any significant active thyroid disease;
• Known sensitivity or allergy to Iodine or Iodine containing products;
• A history of repeated head injury or sustained severe head injury in year prior to onset of tremor;
• A definitive diagnosis of encephalitis;
• Any uncontrolled hypertension or diabetes;
• Any history of cerebrovascular disease;
• Previous evaluation by a Movement Disorder Specialist (MDS);
• 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;
• 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;
• Any new prescription or change in dose of medications for chronic conditions within four (4) weeks of Visit 2.

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• University of Arizona — Tucson, Arizona, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of Florida — Gainesville, Florida, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• University of Texas — Houston, Texas, United States

Full record on ClinicalTrials.gov

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