Trials / Withdrawn
WithdrawnNCT01950468
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
Evaluation of the Diagnostic Efficacy and Safety of [123I]NAV5001 as an Imaging Agent to Aid in the Diagnosis of Parkinsonian Syndromes
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Navidea Biopharmaceuticals · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NAV5001 | A single intravenous dose of 8.0 ± 1.0 mCi |
| DRUG | DaTscan | A single intravenous dose of 3 to 5 mCi |
Timeline
- Start date
- 2017-04-01
- Primary completion
- 2018-03-01
- Completion
- 2018-03-01
- First posted
- 2013-09-25
- Last updated
- 2017-09-13
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01950468. Inclusion in this directory is not an endorsement.