Parkinsonian Syndromes | Two Separate But Identical Studies Evaluating the Safety and Efficacy of ALTROPANE® in the Use of SPECT Imaging for Upper Extremity Tremor
Parkinsonian Syndromes research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:123 I - ALTROPANE®8.0 mCi (±1.0 mCi) will be administered intravenously to each subject.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Parkinsonian SyndromesSubjects with Parkinsonian Syndromes
Non-Parkinsonian SyndromesSubjects with Non-Parkinsonian Syndromes
Start Date: July 2010
Completed Date: July 2011
Phase: Phase 3
Primary Outcome: 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.
Secondary Outcome: To evaluate the safety of 123 I-ALTROPANE® in subjects with upper extremity tremor for less than 2 years.
Study sponsors, principal investigator, and references
Lead Sponsor: Alseres Pharmaceuticals, Inc