{"type":"trials","record":{"id":42394,"source_id":"clinicaltrials-gov","external_id":"NCT02345031","title":"Efficacy and Safety of AUT00063 Versus Placebo in Age-Related Hearing Loss","brief_summary":"This study aims to demonstrate that the investigational drug AUT00063 is effective and safe in the treatment of age-related hearing loss.","overall_status":"Completed","phases":["PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Autifony Therapeutics Limited","enrollment":78,"countries":["United States"],"start_date":"2015-01-01","completion_date":"2016-06-01","last_update_date":"2018-08-09","source_url":"https://clinicaltrials.gov/study/NCT02345031","editorial_summary":"A registered PHASE2 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":"CLARITY-1","age_range":"50 Years to 89 Years","comparator":"AUT00063 (600 mg capsules); (AUT00063 placebo capsules)","organization":"Autifony Therapeutics Limited","interventions":["AUT00063","Placebo"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change in Hearing Loss After 4 Weeks of Treatment — 28 days","Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28 — 28 days","To Further Investigate the Safety and Tolerability Profile of Repeat Administration of AUT00063 by Assessing Vital Sign…","Pharmacokinetic of AUT00063, Plasma Levels — 28 Days"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","source_has_results":true},"controlled_terms":["Age-Related Hearing Loss","AUT00063","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:nct02345031","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2015-01-01 to 2016-06-01","comparator":"AUT00063 (600 mg capsules); (AUT00063 placebo capsules)","confidence":"structured-source","population":"ALL · 50 Years to 89 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":["AUT00063","Placebo"],"participants":78,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE2","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 in Hearing Loss After 4 Weeks of Treatment — 28 days","Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28 — 28 days","To Further Investigate the Safety and Tolerability Profile of Repeat Administration of AUT00063 by Assessing Vital Sign…","Pharmacokinetic of AUT00063, Plasma Levels — 28 Days"],"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.","Source terminology contains: age-related hearing loss.","Title supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","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/42394","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}