- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00724906
Two Separate But Identical Studies Evaluating the Safety and Efficacy of ALTROPANE® in the Use of SPECT Imaging for Upper Extremity Tremor (POET-2)
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 Overview
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 Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Susan Flint, MS, RAC, CCRA, CCRP
- Phone Number: 242 508-497-2360
- Email: sflint@talarisadvisors.com
Study Locations
-
-
Massachusetts
-
Hopkinton, Massachusetts, United States, 01748
- Alseres Pharmaceuticals, Inc
-
Contact:
- Susan Flint, MS, RAC, CCRA, CCRP
- Phone Number: 242 508-497-2360
- Email: sflint@talarisadvisors.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Parkinsonian Syndromes
Subjects with Parkinsonian Syndromes
|
8.0 mCi (±1.0 mCi) will be administered intravenously to each subject.
|
Experimental: Non-Parkinsonian Syndromes
Subjects with Non-Parkinsonian Syndromes
|
8.0 mCi (±1.0 mCi) will be administered intravenously to each subject.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
7 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the safety of 123 I-ALTROPANE® in subjects with upper extremity tremor for less than 2 years.
Time Frame: 7 months
|
7 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALSE-A-02a, ALSE-A-02b
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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