Tinnitus, SubjectiveNCT05507372
Treatment for Post Acute COVID-19 Syndrome
A study testing Pimozide 1 MG in people with Tinnitus, Subjective, run by Applied Biology, Inc..
Trial summary
Post-acute COVID-19 tinnitus has not been treated successfully. As tinnitus may be related to SARS-CoV-2 neurological manifestations. This study aims to investigate if the dopamine receptor antagonists can be used effectively treat COVID-19 induced tinnitus. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tinnitus, Subjective
- What is being tested?
- Pimozide 1 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with subjective tinnitus post COVID-19
- Tinnitus persists for at least 4 weeks
- Prior history of mild or no tinnitus
- 18 years or older
- Any gender
- Females of child bearing age must be on contraception
Who cannot join
- Pregnant
- Patients who participated in any interventional studies in the past 6 months
- Patients with severe hepatic impairment on admission (alanine aminotransferase higher than fivefold the upper limit)
- Patients taking any dopamine receptor antagonists
- Patient having history of hypersensitivity to Pimozide
- Patients unable to comply with the study schedule
- Actively using cortiocosteroids
Trial locations and contacts
No sites are listed yet.
About this study
Post-acute COVID-19 tinnitus has not been treated successfully. As tinnitus may be related to SARS-CoV-2 neurological manifestations. This study aims to investigate if the dopamine receptor antagonists can be used effectively treat COVID-19 induced tinnitus.
Read the detailed description
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative viral pathogen leading to the COVID-19 pandemic. In 2022, after three successive waves of the pandemic, the majority of the human population has been exposed to the SARS-CoV-2 virus. During the two years since the pandemic ensued, multiple reports emerged of patients experiencing COVID-19 emergent symptoms lasting longer than 4 weeks since onset. Up to 15% of patients recovering from COVID-19 experience post-acute COVID-19 induced tinnitus .
To-date, post-acute COVID-19 tinnitus has not been treated successfully. As tinnitus may be related to SARS-CoV-2 neurological manifestations. This study aims to investigate if the dopamine receptor antagonist Pimozide can be used effectively treat COVID-19 induced tinnitus.
- Conditions
- Tinnitus, Subjective
- Being tested
- Pimozide 1 MG
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pimozide 1 MGDrug
Dopamine Receptor Antagonist - Oral Pimozide
| Study group | Role | What they receive |
|---|---|---|
| Dopamine Receptor Modulator | Experimental | Pimozide 1mg Oral Receives: Drug: Pimozide 1 MG |
| Placebo | Placebo comparator | Placebo Oral Receives: Drug: Pimozide 1 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Handicap Inventory (THI)
The Tinnitus Handicap Inventory Scale is between 0-100. And is stratified to Grades between 1-5. A higher grades means more severe handicap from tinnitus.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinnitus, SubjectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Blinded, placebo controlled parallel assignment randomised study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Applied Biology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jupiter Wellness, Inc.
- Responsible party
- Sponsor
- Investigators
- RAHUL RAJENDRA KUNKULOL, MBBS, Principal investigator, DEPT.OF PHARMACOLOGY, RURAL MEDICAL COLLEGE, PIMS- DU (DU), LONI, PIN: 413736
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507372
- Sponsor's protocol ID
- JW-COVID-DRG-001
- Status last verified
- Aug 2022
- First submitted
- 17 Aug 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment for Post Acute COVID-19 Syndrome
- ClinicalTrials.gov ID
- NCT05507372
- Acronym / sponsor ID
- JW-COVID-DRG-001
- Conditions
- Tinnitus, Subjective
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Applied Biology, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Jupiter Wellness, Inc.
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-acute COVID-19 tinnitus has not been treated successfully. As tinnitus may be related to SARS-CoV-2 neurological manifestations. This study aims to investigate if the dopamine receptor antagonists can be used effectively treat COVID-19 induced tinnitus.
Detailed description
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative viral pathogen leading to the COVID-19 pandemic. In 2022, after three successive waves of the pandemic, the majority of the human population has been exposed to the SARS-CoV-2 virus. During the two years since the pandemic ensued, multiple reports emerged of patients experiencing COVID-19 emergent symptoms lasting longer than 4 weeks since onset. Up to 15% of patients recovering from COVID-19 experience post-acute COVID-19 induced tinnitus .
To-date, post-acute COVID-19 tinnitus has not been treated successfully. As tinnitus may be related to SARS-CoV-2 neurological manifestations. This study aims to investigate if the dopamine receptor antagonist Pimozide can be used effectively treat COVID-19 induced tinnitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Blinded, placebo controlled parallel assignment randomised study
| Arm | Type | Receives |
|---|---|---|
| Dopamine Receptor Modulator | Experimental | Drug: Pimozide 1 MGPimozide 1mg Oral |
| Placebo | Placebo comparator | Drug: Pimozide 1 MGPlacebo Oral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with subjective tinnitus post COVID-19
- Tinnitus persists for at least 4 weeks
- Prior history of mild or no tinnitus
- 18 years or older
- Any gender
Key exclusion criteria (7 listed)
- Pregnant
- Patients who participated in any interventional studies in the past 6 months
- Patients with severe hepatic impairment on admission (alanine aminotransferase higher than fivefold the upper limit)
- Patients taking any dopamine receptor antagonists
- Patient having history of hypersensitivity to Pimozide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pimozide 1 MGDopamine Receptor Antagonist - Oral Pimozide | Drug | Dopamine Receptor Modulator, Placebo |
Primary outcome
Tinnitus Handicap Inventory (THI)
Time frame: 4 weeks
The Tinnitus Handicap Inventory Scale is between 0-100. And is stratified to Grades between 1-5. A higher grades means more severe handicap from tinnitus.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Tinnitus, Subjective
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
Not yet recruiting
Advanced Neurofeedback for Tinnitus
Tinnitus, Subjective
Not yet recruiting
Efficacy Analysis of Transcutaneous Auricular Vagus Nerve Stimulation Combined With Tailor-Made Notched Music Therapy in the Treatment of Chronic Subjective Tinnitus
Chronic Subjective Tinnitus
Recruiting
Non-Invasive Neurofeedback Training to Alleviate Tinnitus Distress
Tinnitus Aggravated, Tinnitus
Not yet recruiting
COMPARISON OF MANUAL THERAPY, TINNITUS RETRAINING THERAPY
Somatosensory Tinnitus, Subjektif tınnitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RAHUL RAJENDRA KUNKULOL, MBBS principal investigator
DEPT.OF PHARMACOLOGY, RURAL MEDICAL COLLEGE, PIMS- DU (DU), LONI, PIN: 413736
Questions about this trial
What is this clinical trial studying?
A study testing Pimozide 1 MG in people with Tinnitus, Subjective, run by Applied Biology, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andy Goren, MD (6507040850, andyg@appliedbiology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Handicap Inventory (THI) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.