Status:
UNKNOWN
Two Separate But Identical Studies Evaluating the Safety and Efficacy of ALTROPANE® in the Use of SPECT Imaging for Upper Extremity Tremor
Lead Sponsor:
Alseres Pharmaceuticals, Inc
Conditions:
Parkinsonian Syndromes
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief 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-ALTROPANE® in subjects with upper...
Detailed Description
Each study is a prospective, multi-center, non-randomized, open-label, out patient clinical trial which will include up to 240 subjects per study. Subjects will be male and female, age 40-80 years, wi...
Eligibility Criteria
Inclusion
- Subjects must provide written informed consent prior to the initiation of any study related procedures;
- Age 40 to 80 years;
- Subjects must have had upper extremity tremor for \< 3 years duration.
Exclusion
- 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;
- Any unexpected clinically significant abnormal laboratory or electrocardiogram (ECG) results obtained at Visit 1 and as determined by the PI;
- 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;
- Positive drug screen for opiates, cocaine or amphetamines at Visit 1;
- Positive pregnancy test at Visit 1 and/or Visit 3;
- 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;
- Breast-feeding;
- Inability to lie supine for 1 hour;
- Any thyroid disease other than treated hypothyroidism;
- Known sensitivity or allergy to iodine or iodine containing products;
- Treatment within the 4 weeks before the date of the informed consent with buproprion, methylphenidate or amphetamine;
- Any treatment with anti-Parkinson's drugs within 4 weeks before the date of informed consent.
- Subject eligibility based on exclusion criteria 1, 2, 3, 4, and 20 will be confirmed at Visit 3 prior to dosing.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2011
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00724906
Start Date
July 1 2010
End Date
July 1 2011
Last Update
February 3 2010
Active Locations (1)
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1
Alseres Pharmaceuticals, Inc
Hopkinton, Massachusetts, United States, 01748