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A Cross-Over, Multi-Center Trial to Evaluate the Diagnostic Efficacy and Safety of [123I]NAV5001 as an Imaging Agent to Aid in the Diagnosis of Parkinsonian Syndromes

NCT01950468 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2017-09-13

No results posted yet for this study

Summary

This is a phase 3, open-label, multiple-center, randomized cross-over study to assess the safety and efficacy of \[123I\]NAV5001 SPECT imaging in aiding in the differentiaion of parkinsonian syndromes from non-parkinsonian tremor.

Conditions

  • Parkinson's Syndrome

Interventions

DRUG

NAV5001

A single intravenous dose of 8.0 ± 1.0 mCi

DRUG

DaTscan

A single intravenous dose of 3 to 5 mCi

Sponsors & Collaborators

  • Navidea Biopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Cornelia Reininger, M.D. Ph.D. · Navidea Biopharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-30
Primary Completion
2018-03-31
Completion
2018-03-31
FDA Drug
Yes

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 NCT01950468 on ClinicalTrials.gov