Two Separate But Identical Studies Evaluating the Safety and Efficacy of ALTROPANEĀ® in the Use ofā¦ (NCT00724906) | Clinical Trial Compass
UnknownPhase 3
Two Separate But Identical Studies Evaluating the Safety and Efficacy of ALTROPANEĀ® in the Use of SPECT Imaging for Upper Extremity Tremor
United States240 participantsStarted 2010-07
Plain-language summary
This will be two separate but identical studies: ALSE-A-02a, ALSE-A02b. Each study is designed to evaluate the diagnostic accuracy and safety of a single dose of 123I-ALTROPANEĀ® in subjects with upper extremity tremor for less than three years. 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-ALTROPANEĀ® paired with SPECT imaging permits a more accurate early diagnosis of Parkinson disease than a clinical diagnosis by a general neurologist.
Who can participate
Age range40 Years ā 80 Years
SexALL
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Inclusion criteria
ā. Subjects must provide written informed consent prior to the initiation of any study related procedures;
ā. Age 40 to 80 years;
ā. Subjects must have had upper extremity tremor for \< 3 years duration.
Exclusion criteria
ā. Any clinically significant acute or unstable physical or psychological illness based on medical history or physical examination at Visit 1, as determined by the PI;
ā. Any unexpected clinically significant abnormal laboratory or electrocardiogram (ECG) results obtained at Visit 1 and as determined by the PI;
ā. Any history or drug, narcotic, or alcohol abuse within 2 years before the date of informed consent, as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, Fourth Edition, revised DSM-IVR, American Psychiatric Association, 1994;
ā. Positive drug screen for opiates, cocaine or amphetamines at Visit 1;
ā. Positive pregnancy test at Visit 1 and/or Visit 3;
What they're measuring
1
To evaluate the diagnostic accuracy of a single dose of 123 I-ALTROPANEĀ® as an imaging agent to aid in the diagnosis of Parkinsonian syndromes (PS) in subjects with upper extremity tremor for less than 2 years.