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

NCT00724906 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2010-02-03

No results posted yet for this study

Summary

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.

Conditions

  • Parkinsonian Syndromes

Interventions

DRUG

123 I - ALTROPANE®

8.0 mCi (±1.0 mCi) will be administered intravenously to each subject.

Sponsors & Collaborators

  • Alseres Pharmaceuticals, Inc

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00724906 on ClinicalTrials.gov