drugset / Trial / NCT01950468

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 ↗

Phase 3 Withdrawn Navidea Biopharmaceuticals
RandomizedCrossoverOpen-labelDiagnostic

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.

Timeline

Start
2017-04
Primary completion
2018-03
Completion
2018-03

Outcome

Outcome not reported

Stopped: “The entire drug development program for this molecule was sold to another company.”

Drugs

EvaluationDrugModalityDoseRoute
Subject NAV5001 Diagnostic / imaging agent 8 unknown Intravenous
Comparator ioflupane 123I Unknown 3 unknown Intravenous
Comparator ioflupane 123I Unknown 5 unknown Intravenous

Indications