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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Alseres Pharmaceuticals, Inc.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Alseres Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00724906
First received: July 28, 2008
Last updated: February 2, 2010
Last verified: February 2010
  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)

Resource links provided by NLM:


Further study details as provided by Alseres Pharmaceuticals, Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the safety of 123 I-ALTROPANE® in subjects with upper extremity tremor for less than 2 years. [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

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.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00724906

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

No publications provided

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

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:
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders

ClinicalTrials.gov processed this record on April 16, 2014