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| Sponsor: | Alseres Pharmaceuticals, Inc |
|---|---|
| Information provided by: | Alseres Pharmaceuticals, Inc |
| ClinicalTrials.gov Identifier: | NCT00724906 |
Purpose
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 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-ALTROPANE® paired with SPECT imaging permits a more accurate early diagnosis of Parkinson disease than a clinical diagnosis by a general neurologist.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinsonian Syndromes |
Drug: 123 I - ALTROPANE® |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Evaluation of the Diagnostic Accuracy and Safety of 123 I-ALTROPANE® as an Imaging Agent to Aid in the Diagnosis of Parkinsonian Syndromes (POET-2) |
| Estimated Enrollment: | 240 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Parkinsonian Syndromes
Subjects with Parkinsonian Syndromes
|
Drug: 123 I - ALTROPANE®
8.0 mCi (±1.0 mCi) will be administered intravenously to each subject.
|
|
Experimental: Non-Parkinsonian Syndromes
Subjects with Non-Parkinsonian Syndromes
|
Drug: 123 I - ALTROPANE®
8.0 mCi (±1.0 mCi) will be administered intravenously to each subject.
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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, with approximately 20 sites per study.
Subjects will participate in 5 study visits over the course of the study period. The screening visit will include an assessment of eligibility. The second visit will be the collection of the community neurologist's diagnostic assessment. The third visit, during which all subjects receive a single intravenous (IV) injection of 123I-ALTROPANE® and single photon emission computed tomography (SPECT) imaging, will include appropriate safety assessments before and after dosing. The fourth visit, to occur 24 to 72 hours after SPECT imaging, will include follow up safety assessments as well as the first Movement Disorder Specialist's (MDS) evaluation. The fifth visit, to occur 6 months (±7 days) after SPECT imaging, will include follow-up safety assessments as well as the MDS reevaluation and truth standard diagnosis. The subject's participation in the study will be up to 7 months.
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subject eligibility based on exclusion criteria 1, 2, 3, 4, and 20 will be confirmed at Visit 3 prior to dosing.
Contacts and Locations| Contact: Susan Flint, MS, RAC, CCRA, CCRP | 508-497-2360 ext 242 | sflint@talarisadvisors.com |
| United States, Massachusetts | |
| Alseres Pharmaceuticals, Inc | Not yet recruiting |
| Hopkinton, Massachusetts, United States, 01748 | |
| Contact: Susan Flint, MS, RAC, CCRA, CCRP 508-497-2360 ext 242 sflint@talarisadvisors.com | |
More Information
| 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. |
| ClinicalTrials.gov Identifier: | NCT00724906 History of Changes |
| Other Study ID Numbers: | ALSE-A-02a, ALSE-A-02b |
| Study First Received: | July 28, 2008 |
| Last Updated: | February 2, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Essential Tremor Parkinsonian Tremor Parkinson Disease Upper Extremity Tremor with duration of less than 2 years Diagnosis Subjects |
Upper Extremity Tremor Less Than 2 years |
|
Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders |