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Not recruiting
Phase 4

Migraine Medications

Sponsor:

UCLA

Code:

NCT04404439

Conditions

Tinnitus, Subjective

Tinnitus

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

Nortriptyline + topiramate

Verapamil + paroxetine

Placebo

Study Details

Brief summary:

Tinnitus represents one of the most common and distressing otologic problems, and it causes various somatic and psychological disorders that interfere with the quality of life. It is well-understood that many factors, such as poor education, lower income, or occupational, and recreational activity associated with high noise exposure, influences the prevalence and risk of tinnitus. Although the economic and emotional impact of tinnitus is large, there is currently no FDA-approved medication to treat this condition. However, there are pharmacological options to address the stress, anxiety, and depression that are caused by tinnitus. In this project, we intend to use medications for patients with tinnitus in order to decrease the impact of tinnitus on their daily life and activities.

Conditions

Tinnitus, Subjective

Tinnitus

Study ID

NCT04404439

Start date

Sep 26, 2019

Status verified date

Jan, 2023

Completion date

Dec 30, 2023

Anticipated

Primary completion date

Dec 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with moderate to severe tinnitus.
  • Male or female between the ages of 25 to 85 years.
  • Subject must be compliant with the medication and attend study visits.
  • Must be able to read and write in the English language to provide consenting.

Exclusion Criteria:

  • Pregnancy will result in automatic exclusion from the study. Rule out of pregnancy will be done by a urine pregnancy test to confirm the situation for all women who are of child bearing potential.
  • Subject with history of an adverse reaction to medication being prescribed.
  • Subject suffers from a medical condition or has history that may be concerning to the investigators clinical opinion.
  • All contraindications for the medications which prevent subjects from randomization will be considered as exclusion criteria.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nortriptyline + topiramate

Nortriptyline (7.5 mg) plus topiramate (10 mg) in a single pill initially taken once daily. Dose may be increased as directed by care provider by 7.5mg weekly (to a maximum of 60mg) for nortriptyline, and by 10mg weekly (maximum 80mg) for topiramate.

experimental: Verapamil + paroxetine

Verapamil (30 mg) plus paroxetine (4 mg) in a single pill initially taken once daily. Dose may be increased as directed by care provider by 30mg weekly (to a maximum of 240mg) for verapamil, and by 4mg weekly (maximum 32mg) for paroxetine.

placebo comparator: Placebo

Placebo pill.

Interventions

Nortriptyline + topiramate

Treatment group 1

Verapamil + paroxetine

Treatment group 2

Placebo

Placebo comparator

Primary outcome measure

  • Tinnitus Functional Index (TFI) [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Hamid R Djalilian, MD

800-263-9547hdjalili@hs.uci.edu

Locations

University of California, Irvine Medical Center ENT Clinic (Pavilion 2)

Recruiting

Orange, California, United States, 92868

Contacts

Hamid R Djalilian, MD

800-263-9547hdjalili@hs.uci.edu

Mehdi Abouzari, MD, PhD

714-509-6096mabouzar@hs.uci.edu

Principal Investigator:

Hamid R Djalilian, MD

More Information

Sponsor

University of California, Irvine

Last update posted

Jan 9, 2023

Last verified

Jan, 2023

Keywords

  • tinnitus
  • medication
  • randomized
  • RCT
  • trial
  • migraine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-19. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2023-01-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.