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

NCT00596908 | Completed

• 1 other identifier: ALSE-A-01
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Upper Extremity Tremor

Keywords

Essential Tremor; Parkinsonian Tremor; Parkinson Disease; Upper Extremity Tremor with duration of less than 2 years

Outcome Measures

Primary Outcomes (1)

• To obtain a reference set of 123-I ALTROPANE® SPECT images.

  Image obtained at Visit 2

Secondary Outcomes (1)

• To demonstrate the safety of 123-I ALTROPANE® in subjects with tremor for less than 2 years.

  Safety assessments conducted at Visit 2, Visit 3, and via telephone follow up

Study Arms (2)

1

Subjects with Parkinsonian Tremor (PT)

2

Subjects with non Parkinsonian Tremor (nPT)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with tremor referred to a Movement Disorder Specialist for evaluation

You may qualify if:

• Subjects must provide written informed consent prior to the initiation of any study related procedures;
• Subjects ≥ 40 years of age;
• Subjects with upper extremity tremor for \< 2 years duration.

You may not qualify if:

• 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;
• Any unexpected clinically significant abnormal laboratory or ECG results obtained at Visit 1 and as determined by the Principal Investigator;
• 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});
• Positive urine drug screen at Visit 1;
• 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;
• Positive (+) pregnancy test at Visit 1 and/or Visit 2;
• Breast-feeding;
• Inability to lie supine for 1 hour;
• Any significant active thyroid disease;
• Known sensitivity or allergy to Iodine or Iodine containing products;
• A history of repeated head injury or sustained severe head injury in year prior to onset of tremor;
• A definitive diagnosis of encephalitis;
• Any uncontrolled hypertension or diabetes;

Sponsors & Collaborators

• Alseres Pharmaceuticals, Inc: lead

Study Sites (7)

University of Alabama

Birmingham, Alabama, 35233, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

University of Texas

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

2 blood draws and 2 urine collections per subject.

MeSH Terms

Conditions

Essential Tremor; Parkinson Disease

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 4, 2008
• First Posted: January 17, 2008
• Study Start: December 1, 2007
• Study Completion: March 1, 2009
• Last Updated: May 29, 2009

Record last verified: 2009-05

Locations

US (7)