Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04462198
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Pipeline Therapeutics, Inc.

Brief Summary:
This is a randomized, double-blind study of PIPE-505, or placebo, in subjects with hearing loss associated with speech-in-noise impairment.

Condition or disease Intervention/treatment Phase
Sensorineural Hearing Loss Drug: PIPE-505 Drug: Diluent alone Phase 1 Phase 2

Detailed Description:
This is a randomized-controlled, double-blind study of PIPE-505 or placebo given as an injection one time in subjects with sensorineural hearing loss associated with speech-in-noise difficulty. Visits to the clinic will occur at baseline, dosing, and days 1, 7, 14, 30, 60 and 90 after treatment. Safety will be assessed by periodic measurement of vital signs, ear examination, electrocardiogram (ECG), blood laboratory analyses and occurrence of adverse events (AE). Efficacy will be assessed by periodic audiometry and other audiological tests.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The dose preparer and treatment administrator will be unmasked.
Primary Purpose: Treatment
Official Title: A Phase I/IIa, Randomized, Double-Blind, Placebo-Controlled, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Unilateral Intratympanic PIPE-505 in Subjects With Sensorineural Hearing Loss Associated With Speech-in-Noise Impairment
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PIPE-505 Drug: PIPE-505
Intratympanic injection

Placebo Comparator: Diluent alone Drug: Diluent alone
Intratympanic injection




Primary Outcome Measures :
  1. Safety: Treatment-Emergent Adverse Events (TEAE) [ Time Frame: From baseline to 3 months follow up ]
    Number of participants with TEAEs


Secondary Outcome Measures :
  1. Pharmacokinetics: Area under the curve (AUC) [ Time Frame: From baseline to 3 months follow up ]
  2. Pharmacokinetics: t1/2 (half life) [ Time Frame: From baseline to 3 months follow up ]

Other Outcome Measures:
  1. Exploratory: Speech-in-noise assessments [ Time Frame: 1 month, 2 months, and 3 months after drug administration ]
    Hearing performance in the setting of background noise

  2. Exploratory: Audiogram tests [ Time Frame: 1 month, 2 months, and 3 months after drug administration ]
    Hearing sensitivity and thresholds with a quiet background

  3. Exploratory: Auditory brainstem potential testing [ Time Frame: 1 month, 2 months, and 3 months after drug administration ]
    Electrophysiological assessment of auditory nerve and brainstem responses to auditory signals



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject's primary language is English.
  • Male or female between 18 and 75 years of age, inclusive, at randomization.
  • Diagnosis of bilateral sensorineural hearing loss (SNHL).
  • Normal tympanogram in the ear intended for injection (as defined in protocol) at Screening.
  • Male or female subjects with reproductive potential agree to comply with protocol-approved double barrier contraceptive method during and for 3 months after study drug administration.
  • The subject is in general good medical health with no clinically significant or relevant abnormalities, including medical history, physical exam, vital signs, ECG, and laboratory evaluations (hematology, chemistry, and urinalysis) as assessed by the Investigator.

Exclusion Criteria:

  • History of chronic otitis externa or media, other chronic middle ear disorders, barotrauma, Meniere's disease, endolymphatic hydrops, perilymph fistula, herpes zoster oticus or other infectious etiology of hearing loss.
  • Presence of a genetic, syndromal or developmental auditory disorder or of an autoimmune or serious neurological disorder that could contribute to auditory loss.
  • Evidence of current conductive hearing loss, mixed hearing loss or otosclerosis.
  • History of auditory loss related to exposure to known high-dose ototoxic drugs; any prior exposure to platinum-based medications.
  • Otological disorders that would preclude safe tympanic injection.
  • Presence of a cochlear implant.
  • Evidence of bothersome tinnitus as determined by the Investigator.
  • Intratympanic injection within 6 months of randomization.
  • Use of an investigational product or intervention other than a non-interventional registry study (including vaccine studies) within the greater of 30 days or 5 half-lives (if known) prior to Screening or expected during the study.
  • History of malignancy under current active treatment or considered at substantial risk for progression or recurrence during the study interval, as determined by the Investigator. Note, central nervous system neoplasms or head and neck cancer are excluded from eligibility regardless of treatment status.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04462198


Contacts
Layout table for location contacts
Contact: Deb Jezior 858-254-8480 djezior@pipeline-tx.com
Contact: Julie Iwashita 408-813-9981 jiwashita@pipeline-tx.com

Locations
Layout table for location information
United States, California
Breathe Clear Institute Not yet recruiting
Torrance, California, United States, 90503
Contact: Shay Simes    310-750-3956    shay.s@breatheclearinstitute.com   
Principal Investigator: Steven Davis, MD         
United States, Florida
ENT and Allergy Associates of Florida Recruiting
Boca Raton, Florida, United States, 33487
Contact: Sandy DiBattista, CCMA    561-939-0186    oadibattista@entaaf.com   
Principal Investigator: Mark Widick, MD         
United States, Indiana
Advanced ENT & Allergy Recruiting
New Albany, Indiana, United States, 47150
Contact: Jennifer Leonard, MA, CCRC    502-893-0159 ext 1185    jleonard@advancedentandallergy.com   
Principal Investigator: Steven Shotts, MD         
United States, Kansas
University of Kansas; Dept of Otolaryngology Head & Neck Surgery Recruiting
Kansas City, Kansas, United States, 66160
Contact: Bryan Humphrey, RRT-NPS    913-588-3759    bhumphrey@kumc.edu   
Principal Investigator: Hinrich Staecker, MD         
United States, Kentucky
Advanced ENT & Allergy Recruiting
Louisville, Kentucky, United States, 40220
Contact: Jennifer Leonard, MA, CCRC    502-893-0159 ext 1185    jleonard@advancedentandallergy.com   
Principal Investigator: Andrew Gould, MD         
United States, North Carolina
Charlotte Eye Ear Nose Throat Associates Not yet recruiting
Charlotte, North Carolina, United States, 28210
Contact: Angela Price    704-295-3393    aprice@ceenta.com   
Principal Investigator: Steven Gold, MD         
Piedmont Ear Nose Throat and Associates Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Jessica Mack-Gill    336-768-3361 ext 222    jmack@piedmontent.com   
Contact: Makayla Matthews    336-768-3361 ext 146    mmatthews@piedmontent.com   
Principal Investigator: Kenneth Maxwell, MD         
United States, Utah
Chrysalis Clinical Research Not yet recruiting
Saint George, Utah, United States, 84790
Contact: Rian Farr    435-656-1704    rfarr@sgccr.com   
Contact: Susan Bilanzich       susanb@sgccr.com   
Principal Investigator: Paul Doxey, MD         
Sponsors and Collaborators
Pipeline Therapeutics, Inc.
Investigators
Layout table for investigator information
Study Director: Stephen Huhn, MD Chief Medical Officer, Pipeline Therapeutics, Inc
Layout table for additonal information
Responsible Party: Pipeline Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04462198    
Other Study ID Numbers: PTI-505-101
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pipeline Therapeutics, Inc.:
Hearing Loss
Cochlear synaptopathy
Deafness
Speech-in-noise hearing difficulty
Additional relevant MeSH terms:
Layout table for MeSH terms
Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases