Safety: Treatment-Emergent Adverse Events (TEAE)
Primary
· From baseline to 3 months follow up
Number of participants with TEAEs
| Group | Value | 95% CI |
|---|---|---|
| PIPE-505 | 13 | |
| Placebo | 5 |
Last reviewed · How we verify
NCT04462198
Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss
Completed
Phase 1, PHASE2
Results posted
Last updated 1 April 2025
What this trial tests
Phase 1, PHASE2 trial testing PIPE-505 in Sensorineural Hearing Loss in 28 participants. Completed in 17 June 2021.
Timeline
15 October 2020
Primary endpoint
17 June 2021
17 June 2021
17 June 2021
Quick facts
| Lead sponsor | Contineum Therapeutics |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 28 |
| Start date | 15 October 2020 |
| Primary completion | 17 June 2021 |
| Estimated completion | 17 June 2021 |
| Sites | 8 locations across United States |
Drugs / interventions tested
- PIPE-505 — full drug profile →
- Placebo
Conditions studied
- Sensorineural Hearing Loss — all drugs for Sensorineural Hearing Loss →
Sponsor
Contineum Therapeutics — full company profile →
Who can join
Adults 18 to 75, any sex, with Sensorineural Hearing Loss. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Adverse events — posted to ClinicalTrials.gov
Time frame: 90 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
PIPE-505
Serious: 0/21 (0%)
Deaths: 0/21
Placebo
Serious: 0/7 (0%)
Deaths: 0/7
Other adverse events (31 terms — click to expand)
| Reaction | System | PIPE-505 | Placebo |
|---|---|---|---|
| Ear discomfort | Ear and labyrinth disorders | — | — |
| Inner ear disorder | Ear and labyrinth disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Ear pain | Ear and labyrinth disorders | — | — |
| Ear congestion | Ear and labyrinth disorders | — | — |
| Ear pruritus | Ear and labyrinth disorders | — | — |
| Hypoacusis | Ear and labyrinth disorders | — | — |
| Blood creatine phosphokinase increased | Investigations | — | — |
| Deafness unilateral | Ear and labyrinth disorders | — | — |
| Tinnitus | Ear and labyrinth disorders | — | — |
| Tympanic membrane hyperemia | Ear and labyrinth disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Chills | General disorders | — | — |
| Pain | General disorders | — | — |
| Gastroenteritis | Infections and infestations | — | — |
| Otitis media | Infections and infestations | — | — |
| Tooth infection | Infections and infestations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Blood glucose increased | Investigations | — | — |
| Haemoglobin decreased | Investigations | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Neutrophil count increased | Investigations | — | — |
| Diabetes mellitus | Metabolism and nutrition disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Bursitis | Musculoskeletal and connective tissue disorders | — | — |
| Muscle spasms | Musculoskeletal and connective tissue disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Headache | Nervous system disorders | — | — |
| Renal cyst | Renal and urinary disorders | — | — |
| Asthma | Respiratory, thoracic and mediastinal disorders | — | — |
Data from ClinicalTrials.gov NCT04462198 adverse events section.
Sponsor's own description
This is a randomized, double-blind study of PIPE-505, or placebo, in subjects with hearing loss associated with speech-in-noise impairment.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Investigational Medicinal Products for the Inner Ear: Review of Clinical Trial Characteristics in ClinicalTrials.gov.
Le Prell CG. · · 2021 · cited 18× · PMID 35609594 · DOI 10.1055/s-0041-1735522 -
Recent Therapeutic Progress and Future Perspectives for the Treatment of Hearing Loss.
Lye J, Delaney DS, Leith FK, Sardesai VS, et al · · 2023 · cited 17× · PMID 38137568 · DOI 10.3390/biomedicines11123347 -
Future Pharmacotherapy for Sensorineural Hearing Loss by Protection and Regeneration of Auditory Hair Cells.
Matsunaga M, Nakagawa T. · · 2023 · cited 16× · PMID 36986638 · DOI 10.3390/pharmaceutics15030777 -
The audiogram: Detection of pure-tone stimuli in ototoxicity monitoring and assessments of investigational medicines for the inner ear.
Le Prell CG, Brewer CC, Campbell KCM. · · 2022 · cited 12× · PMID 35931504 · DOI 10.1121/10.0011739 -
Prevention of Noise-Induced Hearing Loss Using Investigational Medicines for the Inner Ear: Previous Trial Outcomes Should Inform Future Trial Design.
Le Prell CG. · · 2022 · cited 12× · PMID 34346254 · DOI 10.1089/ars.2021.0166 -
Speech-in-noise testing: Innovative applications for pediatric patients, underrepresented populations, fitness for duty, clinical trials, and remote services.
Sanchez VA, Arnold ML, Moore DR, Clavier O, et al · · 2022 · cited 10× · PMID 36319253 · DOI 10.1121/10.0014418 -
Rational Design of Inner Ear Drug Delivery Systems.
Maimaitikelimu X, Xuan Z, Ren H, Chen K, et al · · 2025 · cited 4× · PMID 40344640 · DOI 10.1002/advs.202410568
Verify or expand the search:
- PubMed search for NCT04462198
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Sensorineural Hearing Loss
Currently open trials in the same condition.
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- NCT06495268 — Healthy heaAring for Healthy Ageing: Data-driven Hearing Rehabilitation Intervention to Promote Healthy Hearing · NA · active not recruiting
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Other Contineum Therapeutics trials
Trials by the same sponsor.
- NCT06810245 — Study of PIPE-791 for Subjects With Chronic Osteoarthritis Pain or Chronic Low Back Pain · Phase 1 · completed
- NCT06683612 — PET Study of PIPE-791 in Healthy Volunteers and Volunteers With PrMS and IPF · Phase 1 · completed
- NCT06083753 — Study to Evaluate the Safety and Efficacy of PIPE-307 in Subjects With Relapsing-Remitting Multiple Sclerosis · Phase 2 · completed
- NCT05983939 — Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of PIPE-791 and Food Effect in Healthy · Phase 1 · completed
- NCT04941781 — PET Study to Determine the Relationship Between Plasma Concentrations and Muscarinic Type 1 Receptor (M1AChR) Occupancy · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04462198 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Contineum Therapeutics
- Last refreshed: 1 April 2025
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/NCT04462198.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing