Two Separate But Identical Studies Evaluating the Safety and Efficacy of ALTROPANE® in the Use of SPECT Imaging for Upper Extremity Tremor (POET-2)
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ClinicalTrials.gov Identifier: NCT00724906 |
Recruitment Status
: Unknown
Verified February 2010 by Alseres Pharmaceuticals, Inc.
Recruitment status was: Not yet recruiting
First Posted
: July 30, 2008
Last Update Posted
: February 3, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinsonian Syndromes | Drug: 123 I - ALTROPANE® | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 240 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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) |
Study Start Date : | July 2010 |
Estimated Primary Completion Date : | July 2011 |
Estimated Study Completion Date : | July 2011 |
Arm | Intervention/treatment |
---|---|
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.
|
- To evaluate the diagnostic accuracy of a single dose of 123 I-ALTROPANE® as an imaging agent to aid in the diagnosis of Parkinsonian syndromes (PS) in subjects with upper extremity tremor for less than 2 years. [ Time Frame: 7 months ]
- To evaluate the safety of 123 I-ALTROPANE® in subjects with upper extremity tremor for less than 2 years. [ Time Frame: 7 months ]

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Ages Eligible for Study: | 40 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00724906
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 |
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 |
First Posted: | July 30, 2008 Key Record Dates |
Last Update Posted: | February 3, 2010 |
Last Verified: | February 2010 |
Keywords provided by Alseres Pharmaceuticals, Inc:
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 |
Additional relevant MeSH terms:
Syndrome Disease Pathologic Processes Cocaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents |
Peripheral Nervous System Agents Vasoconstrictor Agents Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents |