150 Participants Needed

Migraine Medications for Tinnitus

HR
Overseen ByHamid R Djalilian, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of California, Irvine
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different medication combinations to help people with tinnitus. One group gets nortriptyline and topiramate, another gets verapamil and paroxetine. The goal is to see if these medications can reduce the stress and anxiety caused by tinnitus. Paroxetine has been studied previously for its potential to relieve tinnitus symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the combination of Nortriptyline and Topiramate safe for humans?

The combination of Nortriptyline and Topiramate has been studied for migraine prevention, and while it can be effective, it may have side effects that vary among individuals. It's important to balance the potential benefits with the risk of adverse effects, and this should be discussed with a healthcare provider.12345

How does the drug combination of Nortriptyline + Topiramate and Verapamil + Paroxetine differ from other treatments for tinnitus?

This drug combination is unique because it combines medications typically used for migraines and depression, which may address both the neurological and psychological aspects of tinnitus. While no drugs are specifically approved for tinnitus, using these medications together could target multiple pathways involved in the condition, offering a novel approach compared to traditional treatments.678910

What data supports the effectiveness of the drug Nortriptyline + Topiramate for treating tinnitus?

Research suggests that nortriptyline, a component of the treatment, may help some patients with tinnitus, especially those with depression, although it does not directly reduce tinnitus severity. Additionally, similar antidepressants like amitriptyline have shown effectiveness in reducing tinnitus symptoms.711121314

Who Is on the Research Team?

HR

Hamid R Djalilian, MD

Principal Investigator

Univeristy of California, Irvine

Are You a Good Fit for This Trial?

This trial is for adults aged 25-85 with moderate to severe tinnitus. Participants must be able to read and write English, attend study visits, and comply with medication regimens. Pregnant individuals, those with adverse reactions to the medications being tested or certain medical conditions are excluded.

Inclusion Criteria

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.
You have moderate to severe ringing in your ears.
See 5 more

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
You had a bad reaction to the medication before.
Subject suffers from a medical condition or has history that may be concerning to the investigators clinical opinion
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either nortriptyline plus topiramate, verapamil plus paroxetine, or placebo for 8 weeks. Dosages may be increased weekly based on symptoms.

8 weeks
Weekly visits (in-person or virtual) for symptom monitoring and dosage adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Nortriptyline + Topiramate
  • Placebo
  • Verapamil + Paroxetine
Trial Overview The trial tests if migraine medications can help treat tinnitus. It compares the effectiveness of Nortriptyline plus Topiramate versus Verapamil plus Paroxetine against a placebo in reducing the impact of tinnitus on daily life.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Verapamil + paroxetineExperimental Treatment1 Intervention
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.
Group II: Nortriptyline + topiramateExperimental Treatment1 Intervention
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.
Group III: PlaceboPlacebo Group1 Intervention
Placebo pill.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials
580
Recruited
4,943,000+

Published Research Related to This Trial

Antidepressants, particularly tricyclics, can be beneficial in treating both migraine and depression, but often a single antidepressant is not enough to effectively manage both conditions, necessitating combination therapies.
The review highlights the importance of understanding the interactions between various medications, including antidepressants and migraine prophylactics, to ensure effective treatment while minimizing the risk of adverse interactions.
Antidepressants in long-term migraine prevention.Koch, HJ., Jürgens, TP.[2018]
Preventive pharmacological treatments for migraines, such as amitriptyline, divalproex, topiramate, and beta-adrenergic blockers (like propranolol), have strong evidence supporting their efficacy, based on clinical experience and level I evidence.
While these medications can be effective, they also come with varying degrees of side effects that may limit their use, highlighting the importance of balancing treatment efficacy with safety and patient preferences in migraine management.
Prophylactic pharmacotherapy for migraine headaches.Buchanan, TM., Ramadan, NM.[2006]
Divalproex sodium, the only FDA-approved antiepileptic drug for migraine prevention, significantly reduced migraine frequency by 30% to 40% in patients over 12 weeks, with nearly half of the patients experiencing a 50% or more reduction in headache frequency.
Gabapentin also showed significant efficacy in reducing migraine frequency, with nearly half of patients at higher doses achieving a 50% or more reduction, while topiramate demonstrated effectiveness in reducing migraine frequency in two separate trials, with some patients even experiencing weight loss.
Antiepileptic drugs in migraine prevention.Mathew, NT.[2019]

Citations

PHARMACOLOGICAL TREATMENTS FOR TINNITUS: NEW AND OLD. [2021]
Efficacy of amitriptyline in the treatment of subjective tinnitus. [2019]
A randomized trial of nortriptyline for severe chronic tinnitus. Effects on depression, disability, and tinnitus symptoms. [2013]
Antidepressant treatment of tinnitus patients: report of a randomized clinical trial and clinical prediction of benefit. [2022]
Review of Pharmacotherapy for Tinnitus. [2021]
Antidepressants in long-term migraine prevention. [2018]
Prophylactic pharmacotherapy for migraine headaches. [2006]
Antiepileptic drugs in migraine prevention. [2019]
Topiramate plus nortriptyline in the preventive treatment of migraine: a controlled study for nonresponders. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Pharmacologic Prevention of Migraine: A Narrative Review of the State of the Art in 2018. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Sudden hearing loss associated with piroxicam. [2013]
An update: emerging drugs for tinnitus. [2019]
Antidepressant therapy in tinnitus. [2013]
14.United Statespubmed.ncbi.nlm.nih.gov
Randomized placebo-controlled trial of a selective serotonin reuptake inhibitor in the treatment of nondepressed tinnitus subjects. [2022]
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