NCT01187888

✓ Unanimous Initial: hospital Requery: other — The study is conducted at an academic center and involves outpatient administration of a daily medication, fitting the 'other' classification for an outpatient or community setting.

✓ Unanimous Initial: other Requery: other — This is a drug trial for Progressive Supranuclear Palsy with oral medication (rasagiline tablets) taken once daily for one year, indicating outpatient clinic visits rather than inpatient hospitalization.

✓ Unanimous Initial: other Requery: other — This is a Phase III trial for Progressive Supranuclear Palsy involving oral once-daily study medication and regular outpatient assessment visits, without any requirement for hospital admission or inpatient care.

✓ Unanimous Initial: fully powered RCT Requery: fully powered RCT — The trial is Phase III, indicative of testing clinical efficacy, and a large sample size calculation is expected though the enrollment is smaller, aligning with clinical outcomes measurement rather than feasibility. Thinking: fully powered RCT — Phase III randomized, double-blind trial assessing clinical efficacy endpoints, not recruitment or feasibility metrics.

✓ Unanimous Initial: feasibility RCT Requery: feasibility RCT — Despite being labeled Phase III, the enrollment of only 44 subjects is too small for a fully powered efficacy trial in neurodegeneration, suggesting this is a pilot study to test feasibility and establish preliminary efficacy estimates. Thinking: fully powered RCT — Phase III trial with clinical effectiveness primary outcomes (PSP rating scale deterioration and L-DOPA need) despite modest enrollment of 44 for this rare disease.

✓ Unanimous Initial: fully powered RCT Requery: feasibility RCT — Despite being designated as a Phase III trial, the enrollment of only 44 participants and the clinical effectiveness outcomes indicate it is likely underpowered and functions as a feasibility or pilot study.

✓ Unanimous Initial: no Requery: no — The trial does not involve specific symptom measures using validated instruments; it focuses on neurodegeneration, postural instability, and the use of the PSP rating scale, which is not a symptom measure scale.

✓ Unanimous Initial: yes Requery: no — The primary outcomes focus on L-DOPA therapy requirements and PSP rating scale scores for disease progression assessment, while secondary outcomes measure gait disturbances, safety parameters, and adverse events, but none use validated symptom-specific instruments like pain scales, depression scales, or symptom burden measures.

✓ Unanimous Initial: yes

✓ Unanimous Initial: off label use Requery: off label use — Rasagiline is approved for Parkinson’s Disease but is being assessed for use in Progressive Supranuclear Palsy, which is not an approved indication. Thinking: off label use — Rasagiline is an FDA-approved MAO-B inhibitor for Parkinson’s disease but is being tested here for the non-approved indication of progressive supranuclear palsy.

✓ Unanimous Initial: other Requery: other — Rasagiline is an FDA-approved monoamine oxidase type B inhibitor being tested for progressive supranuclear palsy, which is an off-label use from its approved indication for Parkinson's disease, but since it's being studied in a Phase III trial for this specific indication, it falls under 'other' pharmacologic intervention. Thinking: off label use — Rasagiline is FDA-approved for Parkinson's disease but is being tested here for Progressive Supranuclear Palsy, a different indication.

✓ Unanimous Initial: other Requery: off label use — Rasagiline (trade name Azilect) is an FDA/EMA-approved drug for Parkinson's disease, but it is being tested here for the non-approved indication of Progressive Supranuclear Palsy.