Nortriptyline + topiramate for Tinnitus

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Tinnitus+2 More
Nortriptyline + topiramate - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether using medications can help decrease the negative impact that tinnitus has on patients' daily lives.

Eligible Conditions
  • Tinnitus
  • Tinnitus, Subjective

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 8 weeks

8 weeks
Patient Health Questionnaire (PHQ)
Perceived Stress Scale (PSS)
Sleep Quality Index (SQI)
Tinnitus Functional Index (TFI)
Visual Analog Scale (VAS)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

Verapamil + paroxetine
1 of 3
Nortriptyline + topiramate
1 of 3
Placebo
1 of 3
Experimental Treatment
Non-Treatment Group

150 Total Participants · 3 Treatment Groups

Primary Treatment: Nortriptyline + topiramate · Has Placebo Group · Phase 4

Verapamil + paroxetine
Drug
Experimental Group · 1 Intervention: Verapamil + paroxetine · Intervention Types: Drug
Nortriptyline + topiramate
Drug
Experimental Group · 1 Intervention: Nortriptyline + topiramate · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks

Who is running the clinical trial?

University of California, IrvineLead Sponsor
496 Previous Clinical Trials
1,878,163 Total Patients Enrolled
3 Trials studying Tinnitus
223 Patients Enrolled for Tinnitus
Hamid R Djalilian, MDPrincipal InvestigatorUniveristy of California, Irvine

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The subject must take the medication as prescribed and attend all study visits.
You must be able to read and write in English in order to provide consent.
Patients who have tinnitus that is moderate to severe.
You must be at least 25 years old and no older than 85 to be a part of this study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 18th, 2021

Last Reviewed: October 25th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Texas22.2%
California22.2%
Missouri11.1%
Other44.4%
How old are they?
18 - 6575.0%
65+25.0%
What site did they apply to?
University of California, Irvine Medical Center ENT Clinic (Pavilion 2)100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria25.0%
Met criteria75.0%

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. University of California, Irvine Medical Center ENT Clinic (Pavilion 2): < 48 hours
Typically responds via
Email100.0%
References