Last reviewed · How we verify

NCT00724906: POET-2

Evaluation of the Diagnostic Accuracy and Safety of 123 I-ALTROPANE® as an Imaging Agent to Aid in the Diagnosis of Parkinsonian Syndromes (POET-2)

Status unknown Phase 3 Last updated 2 February 2010
What this trial tests

Phase 3 trial testing 123 I - ALTROPANE® in Parkinsonian Syndromes in 240 participants. Status unknown.

Timeline
1 July 2010
Primary endpoint
1 July 2011
1 July 2011

Quick facts

Lead sponsorAlseres Pharmaceuticals, Inc
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment240
Start date1 July 2010
Primary completion1 July 2011
Estimated completion1 July 2011
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Alseres Pharmaceuticals, Inc — full company profile →

Who can join

Adults 40 to 80, any sex, with Parkinsonian Syndromes. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00724906.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing