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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)
Phase 3 trial testing 123 I - ALTROPANE® in Parkinsonian Syndromes in 240 participants. Status unknown.
1 July 2011
Quick facts
| Lead sponsor | Alseres Pharmaceuticals, Inc |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 240 |
| Start date | 1 July 2010 |
| Primary completion | 1 July 2011 |
| Estimated completion | 1 July 2011 |
| Sites | 1 location across United States |
Drugs / interventions tested
- 123 I - ALTROPANE® — full drug profile →
Conditions studied
- Parkinsonian Syndromes — all drugs for Parkinsonian Syndromes →
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.
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To evaluate the diagnostic accuracy of a single dose of 123 I-ALTROPANE® as an imaging agent to aid in the diagnosis of Parkinsonian syndromes (PS) in subjects with upper extremity tremor for less than 2 years.
Time frame: 7 months
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:
- PubMed search for NCT00724906
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00724906 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Alseres Pharmaceuticals, Inc
- Last refreshed: 2 February 2010
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