Two Separate But Identical Studies Evaluating the Safety and Efficacy of ALTROPANE® in the Use of SPECT Imaging for Upper Extremity Tremor (POET-2)

Study Description

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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 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 or disease	Intervention/treatment	Phase
Parkinsonian Syndromes	Drug: 123 I - ALTROPANE®	Phase 3

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, 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 Design

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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

Arms and Interventions

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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.

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. To evaluate the safety of 123 I-ALTROPANE® in subjects with upper extremity tremor for less than 2 years. [ Time Frame: 7 months ]

Eligibility Criteria

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

Criteria

Inclusion Criteria:

1. Subjects must provide written informed consent prior to the initiation of any study related procedures;
2. Age 40 to 80 years;
3. Subjects must have had upper extremity tremor for < 3 years duration.

Exclusion Criteria:

1. 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;
2. Any unexpected clinically significant abnormal laboratory or electrocardiogram (ECG) results obtained at Visit 1 and as determined by the PI;
3. 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;
4. Positive drug screen for opiates, cocaine or amphetamines at Visit 1;
5. Positive pregnancy test at Visit 1 and/or Visit 3;
6. Participation in an investigational drug or device clinical trial within 30 days prior to the date of informed consent;
7. Previous participation in any 123I-ALTROPANE® trial;
8. Any exposure to radiopharmaceuticals within 30 days prior to the date of informed consent;
9. Breast-feeding;
10. Inability to lie supine for 1 hour;
11. Any thyroid disease other than treated hypothyroidism;
12. Known sensitivity or allergy to iodine or iodine containing products;
13. Treatment within the 4 weeks before the date of the informed consent with buproprion, methylphenidate or amphetamine;
14. 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.

Contacts and Locations

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Contacts

Contact: Susan Flint, MS, RAC, CCRA, CCRP	508-497-2360 ext 242	sflint@talarisadvisors.com

Locations

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

Sponsors and Collaborators

Alseres Pharmaceuticals, Inc

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	July 30, 2008
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