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| Sponsor: | Alseres Pharmaceuticals, Inc |
|---|---|
| Information provided by: | Alseres Pharmaceuticals, Inc |
| ClinicalTrials.gov Identifier: | NCT00596908 |
Purpose
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.
| Condition |
|---|
|
Upper Extremity Tremor |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | 123I-ALTROPANE® Reference Image Acquisition in Subjects With Diagnostically Uncertain Tremor (AIM) |
2 blood draws and 2 urine collections per subject.
| Enrollment: | 54 |
| Study Start Date: | December 2007 |
| Study Completion Date: | March 2009 |
| Groups/Cohorts |
|---|
|
1
Subjects with Parkinsonian Tremor (PT)
|
|
2
Subjects with non Parkinsonian Tremor (nPT)
|
This is a prospective, multi-center, non-randomized, open-label, out patient clinical trial which will include up to 90 subjects, male or female, 40 years of age or older.
This study is designed to obtain an imaging training set that will be used to evaluate images in future trials. Up to ninety subjects with upper extremity tremor for less than 2 years duration will be enrolled. Of these, at least thirty Parkinsonian syndromes subjects and at least thirty non-Parkinsonian syndromes subjects as diagnosed by a MDS will be enrolled.
Subjects will participate in three study visits over the course of the study period. The screening visit will include an assessment of eligibility as well as the collection of the MDS diagnosis. The second visit, during which all subjects receive a single intravenous injection of 123I-ALTROPANE® followed by SPECT imaging, will include appropriate safety assessments before and after dosing. The third visit will include follow-up safety. The subjects' participation in the study will range between 30 and 40 days.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with tremor referred to a Movement Disorder Specialist for evaluation
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| University of Alabama | |
| Birmingham, Alabama, United States, 35233 | |
| United States, Arizona | |
| University of Arizona | |
| Tucson, Arizona, United States, 85724 | |
| United States, California | |
| Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| United States, Florida | |
| University of Florida | |
| Gainesville, Florida, United States, 32610 | |
| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, Texas | |
| University of Texas | |
| Houston, Texas, United States, 77030 | |
| UT Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
More Information
| Responsible Party: | Alseres Pharmaceuticals, Inc ( Susan M. Flint, M.S., R.A.C., C.C.R.A., C.C.R.P. Senior VP Drug Development ) |
| Study ID Numbers: | ALSE-A-01 |
| Study First Received: | January 4, 2008 |
| Last Updated: | May 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00596908 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Essential Tremor Parkinsonian Tremor Parkinson Disease Upper Extremity Tremor with duration of less than 2 years |
|
Signs and Symptoms Nervous System Diseases Neurologic Manifestations Dyskinesias Tremor |