{"type":"trials","record":{"id":42390,"source_id":"clinicaltrials-gov","external_id":"NCT01518920","title":"A Study Of The Effects Of PF-04958242 In Subjects With Age-Related Hearing Loss","brief_summary":"The objective of this study is to examine the safety, tolerability, and effects on hearing thresholds of two single doses of PF-04958242 and placebo in subjects with age-related hearing loss.","overall_status":"Completed","phases":["PHASE1"],"study_type":"INTERVENTIONAL","sponsor":"Biogen","enrollment":44,"countries":["United States"],"start_date":"2011-12-01","completion_date":"2013-02-01","last_update_date":"2019-11-21","source_url":"https://clinicaltrials.gov/study/NCT01518920","editorial_summary":"A registered PHASE1 study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:25:34.048307+00:00","last_seen_at":"2026-09-25T06:25:04.647+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"50 Years to 75 Years","comparator":"Placebo","organization":"Biogen","interventions":["PF-04958242","Placebo"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change from baseline to 1 hour post-dose in pure tone audiometry averaged over 2 and 4 kHz — 1 hour","Change from baseline to 5 hours post-dose in pure tone audiometry averaged over 2 and 4 kHz — 5 hours","Change from baseline to 1 hr and 5 hrs post-dose in Speech Discrimination Score — 1 hour, 5 hours","Change from baseline to 1 hr and 5 hrs post dose in Speech In Noise Testing — 1 hour, 5 hours","Change from baseline to 1 hr and 5 hrs post dose in Tinnitus Severity Ranking Scale — 1 hour, 5 hours","Plasma PF 04958242 concentrations at 45 min post dose and following endpoint assessments at 1 and 5 hrs post dose. — 45…"],"design_description":"RANDOMIZED · CROSSOVER · TREATMENT · TRIPLE","source_has_results":false},"controlled_terms":["Hearing Loss, Sensorineural","PF-04958242","Placebo"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Title contains controlled term: age-related hearing loss.","quality_checked_at":"2026-09-25T06:25:07.732232+00:00","duplicate_cluster_key":"id:nct01518920","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2011-12-01 to 2013-02-01","comparator":"Placebo","confidence":"structured-source","population":"ALL · 50 Years to 75 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:25:04.668Z","intervention":["PF-04958242","Placebo"],"participants":44,"study_design":"RANDOMIZED · CROSSOVER · TREATMENT · TRIPLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE1","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Change from baseline to 1 hour post-dose in pure tone audiometry averaged over 2 and 4 kHz — 1 hour","Change from baseline to 5 hours post-dose in pure tone audiometry averaged over 2 and 4 kHz — 5 hours","Change from baseline to 1 hr and 5 hrs post-dose in Speech Discrimination Score — 1 hour, 5 hours","Change from baseline to 1 hr and 5 hrs post dose in Speech In Noise Testing — 1 hour, 5 hours","Change from baseline to 1 hr and 5 hrs post dose in Tinnitus Severity Ranking Scale — 1 hour, 5 hours","Plasma PF 04958242 concentrations at 45 min post dose and following endpoint assessments at 1 and 5 hrs post dose. — 45…"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"hearing-aging","is_published":true,"match_reasons":["Title contains controlled term: age-related hearing loss.","Abstract contains controlled term: age-related hearing loss.","Title supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Hearing ageing","slug":"hearing-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/42390","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}