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| Tracking Information | |
|---|---|
| First Received Date ICMJE | January 4, 2008 |
| Last Updated Date | May 28, 2009 |
| Start Date ICMJE | December 2007 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE |
To obtain a reference set of 123-I ALTROPANE® SPECT images. [ Time Frame: Image obtained at Visit 2 ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00596908 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
To demonstrate the safety of 123-I ALTROPANE® in subjects with tremor for less than 2 years. [ Time Frame: Safety assessments conducted at Visit 2, Visit 3, and via telephone follow up ] [ Designated as safety issue: Yes ] |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Descriptive Information | |
| Brief Title ICMJE | 123I-ALTROPANE® Reference Image Acquisition in Subjects With Diagnostically Uncertain Tremor |
| Official Title ICMJE | 123I-ALTROPANE® Reference Image Acquisition in Subjects With Diagnostically Uncertain Tremor (AIM) |
| Brief Summary | 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. |
| Detailed Description | 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. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Cohort, Prospective |
| Condition ICMJE | Upper Extremity Tremor |
| Intervention ICMJE | |
| Study Arms / Comparison Groups |
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| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 54 |
| Completion Date | March 2009 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 40 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00596908 |
| Responsible Party | Susan M. Flint, M.S., R.A.C., C.C.R.A., C.C.R.P. Senior VP Drug Development, Alseres Pharmaceuticals, Inc |
| Study ID Numbers ICMJE | ALSE-A-01 |
| Study Sponsor ICMJE | Alseres Pharmaceuticals, Inc |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | Alseres Pharmaceuticals, Inc |
| Verification Date | May 2009 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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