123I-ALTROPANE® Reference Image Acquisition in Subjects With Diagnostically Uncertain Tremor (AIM)

This study has been completed.
Sponsor:
Information provided by:
Alseres Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00596908
First received: January 4, 2008
Last updated: May 28, 2009
Last verified: May 2009
  Purpose

This study is designed to obtain an imaging training set that will be used to evaluate images in future trials. 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
Upper Extremity Tremor

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 123I-ALTROPANE® Reference Image Acquisition in Subjects With Diagnostically Uncertain Tremor (AIM)

Resource links provided by NLM:


Further study details as provided by Alseres Pharmaceuticals, Inc:

Primary Outcome Measures:
  • To obtain a reference set of 123-I ALTROPANE® SPECT images. [ Time Frame: Image obtained at Visit 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To demonstrate the safety of 123-I ALTROPANE® in subjects with tremor for less than 2 years. [ Time Frame: Safety assessments conducted at Visit 2, Visit 3, and via telephone follow up ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

2 blood draws and 2 urine collections per subject.


Enrollment: 54
Study Start Date: December 2007
Study Completion Date: March 2009
Groups/Cohorts
1
Subjects with Parkinsonian Tremor (PT)
2
Subjects with non Parkinsonian Tremor (nPT)

Detailed Description:

This is a prospective, multi-center, non-randomized, open-label, out patient clinical trial which will include up to 90 subjects, male or female, 40 years of age or older.

This study is designed to obtain an imaging training set that will be used to evaluate images in future trials. Up to ninety subjects with upper extremity tremor for less than 2 years duration will be enrolled. Of these, at least thirty Parkinsonian syndromes subjects and at least thirty non-Parkinsonian syndromes subjects as diagnosed by a MDS will be enrolled.

Subjects will participate in three study visits over the course of the study period. The screening visit will include an assessment of eligibility as well as the collection of the MDS diagnosis. The second visit, during which all subjects receive a single intravenous injection of 123I-ALTROPANE® followed by SPECT imaging, will include appropriate safety assessments before and after dosing. The third visit will include follow-up safety. The subjects' participation in the study will range between 30 and 40 days.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with tremor referred to a Movement Disorder Specialist for evaluation

Criteria

Inclusion Criteria:

  1. Subjects must provide written informed consent prior to the initiation of any study related procedures;
  2. Subjects ≥ 40 years of age;
  3. Subjects with upper extremity tremor for < 2 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 Principal Investigator;
  2. Any unexpected clinically significant abnormal laboratory or ECG results obtained at Visit 1 and as determined by the Principal Investigator;
  3. Any history of drug, narcotic, or alcohol abuse within 2 years prior to the date of informed consent, as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, 4th Edition (DSM-IVR {American Psychiatric Association, 1994 #2});
  4. Positive urine drug screen at Visit 1;
  5. Participation in an investigational drug or device clinical trial within 30 days prior to the date of informed consent;
  6. Previous participation in any 123I-ALTROPANE® trial;
  7. Any exposure to radiopharmaceuticals within 30 days prior to the date of informed consent;
  8. Positive (+) pregnancy test at Visit 1 and/or Visit 2;
  9. Breast-feeding;
  10. Inability to lie supine for 1 hour;
  11. Any significant active thyroid disease;
  12. Known sensitivity or allergy to Iodine or Iodine containing products;
  13. A history of repeated head injury or sustained severe head injury in year prior to onset of tremor;
  14. A definitive diagnosis of encephalitis;
  15. Any uncontrolled hypertension or diabetes;
  16. Any history of cerebrovascular disease;
  17. Previous evaluation by a Movement Disorder Specialist (MDS);
  18. Treatment within the previous six (6) months prior to informed consent with bupropion, metoclopramide, cinnarizine, flunarizine, methylphenidate, reserpine, modafinil, alpha methyldopa, amphetamine, or any anti-psychotic medication;
  19. Any treatment with anti-Parkinson's drugs or anti-tremor medications within three (3) months prior to the date of the subject signing the informed consent;
  20. Any new prescription or change in dose of medications for chronic conditions within four (4) weeks of Visit 2.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596908

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35233
United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85724
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
University of Texas
Houston, Texas, United States, 77030
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: NCT00596908     History of Changes
Other Study ID Numbers: ALSE-A-01
Study First Received: January 4, 2008
Last Updated: May 28, 2009
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

Additional relevant MeSH terms:
Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014