Nortriptyline + Topiramate for Meniere's Disease
Recruiting in Palo Alto (17 mi)
Overseen byHamid Djalilian, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of California, Irvine
Disqualifiers: Pregnancy, Surgery for Meniere's, Psychosis, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
This trial is testing two different sets of medications to see which works better for treating Meniere's disease. One set calms nerves and stabilizes mood, while the other reduces fluid buildup. The goal is to find an effective treatment for patients suffering from severe symptoms like vertigo and hearing loss.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. Please consult with the trial coordinators for more details.
What data supports the idea that Nortriptyline + Topiramate for Meniere's Disease is an effective treatment?
The available research does not provide specific data on the effectiveness of Nortriptyline + Topiramate for Meniere's Disease. However, it mentions other treatments like Innovar, which helped 58% of patients with long-lasting relief from vertigo. This suggests that while there are effective treatments for Meniere's Disease, the specific combination of Nortriptyline + Topiramate is not directly supported by the data provided.12345
What safety data exists for Nortriptyline + Topiramate in treating Meniere's Disease?
The provided research does not contain specific safety data for the combination of Nortriptyline and Topiramate in treating Meniere's Disease. However, it mentions that there has been no randomized controlled trial (RCT) on the efficacy of topiramate for vestibular disorders. Topiramate is known to have adverse effects such as paresthesias and cognitive side effects, with a safety profile based on trials involving epilepsy patients. No specific safety data for Nortriptyline in this context is provided.26789
Eligibility Criteria
This trial is for adults aged 25-85 with active or frequent Meniere's Disease who can take medication regularly and attend study visits. They must be able to read and write English to consent. Excluded are pregnant women, those with a history of surgery for Meniere's, adverse reactions to the study medications, concerning medical conditions, psychosis, neurological tumors, or contraindications preventing safe use of the drugs.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
I am between 25 and 85 years old.
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Exclusion Criteria
I am not allergic or unable to take any of the trial medications.
Pregnancy will result in automatic exclusion from the study. A urine pregnancy test to rule out pregnancy for all women who are of childbearing potential
I have a brain or spinal cord tumor.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either nortriptyline plus topiramate or hydrochlorothiazide plus triamterene for 8 weeks, with possible dosage increases based on symptom improvement
8 weeks
Weekly visits for symptom monitoring and dosage adjustments
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- nortriptyline + topiramate (Tricyclic Antidepressant + Anticonvulsant)
Trial OverviewThe trial tests if migraine medications nortriptyline and topiramate can treat Meniere's Disease symptoms like vertigo and hearing loss. There are no FDA-approved treatments for this condition yet; these drugs have shown promise in clinical practice.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: nortriptyline + topiramateExperimental Treatment1 Intervention
Nortriptyline (starting dose 7.5 mg) plus Topiramate (starting dose 10 mg) with appropriate dosage increase as necessary
Group II: hydrochlorothiazide + triamterene + placeboActive Control1 Intervention
hydrochlorothiazide (starting dose 25 mg) plus triamterene (starting dose 37.5 mg) with placebo being added in case of a dosage increase
nortriptyline + topiramate is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Pamelor + Topamax for:
- Migraine prophylaxis
- Seizure control
- Depression
🇪🇺 Approved in European Union as Nortriptyline + Topiramate for:
- Migraine prophylaxis
- Seizure control
- Depression
- Neuropathic pain
🇨🇦 Approved in Canada as Nortriptyline + Topiramate for:
- Migraine prophylaxis
- Seizure control
- Depression
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California, Irvine Medical Center ENT Clinic (Pavilion 2)Orange, CA
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Who Is Running the Clinical Trial?
University of California, IrvineLead Sponsor
References
Evaluating Quality of Life in Patients With Meniere's Disease Treated as Migraine. [2018]To evaluate the change in quality of life (QOL) of patients with Meniere's disease (MD) after treatment with migraine prophylaxis therapy.
Innovar treatment for Meniere's disease. [2019]Patients with intractable vertigo due to clinical Meniere's disease were offered treatment with Innovar, a neurolept analgesic. The patients were from a single clinical practice, had failed conventional dietary and medical treatment and were eligible on clinical grounds for endolymphatic sac surgery. After a follow-up of 2-8 years, 58% of patients had long-lasting relief of vertigo. Hearing was not affected. Risk factors for a favorable response were male gender, fluctuating hearing, and early stage of the disorder. Innovar is a safe, cost-effective second-line therapy for patients with Meniere's disease who have failed conventional first-line medical therapy.
Meniere's disease in the elderly. [2013]Menière disease usually begins in adults from 20 to 60 years old, and occurs in more than 10% of patients older than 65. The treatment of Menière disease in the elderly represents a challenge because of polymedication. Antivertiginous drugs such as betahistine and cinnarizin give good results with minor secondary effects. In contrast, major vestibular suppressor drugs such as thiethylperazin must be avoided as long-term treatment because of their side effects. Definitive vestibular surgical deafferentations such as labyrinthectomy and selective vestibular neurectomy represent optional procedures but must be carefully evaluated from case to case. Ablative procedures remain the efficient treatment of drop attacks, which represent a high potential risk of severe injuries by older patients sometimes with important social consequences.
Comparison of second-echelon treatments for Ménière's disease. [2014]To compare the efficacy of treatments commonly offered to patients with Ménière's disease who fail conservative medical therapy including diuretics and a sodium-restricted diet.
Impact of Ménière's disease on quality of life. [2022]To describe health-related quality of life among patients with Ménière's disease in whom conventional therapy failed and who requested further medical intervention.
Topiramate for the treatment of epilepsy and other nervous system disorders. [2019]Initially synthesized as an oral hypoglycemic agent, topiramate was approved for use as an anticonvulsant in 1996. Its broad spectrum efficacy in epilepsy, including as monotherapy and in children, is well established. Topiramate has also been used in the management of nonepileptic neurologic and psychiatric conditions, including migraine prophylaxis (with firmly established efficacy), obesity (with some evidence of long-term maintenance of weight loss), substance dependence, bipolar disorder and neuropathic pain, and it has been investigated as a possible neuroprotective agent. Paresthesias and cognitive side effects are the most common troublesome adverse effects. Recent trends towards lower doses may help achieve the best combination of efficacy and tolerability.
Safety of topiramate: adverse events and relationships to dosing. [2022]To date, 1,809 individuals have been exposed to topiramate (TPM), primarily adults with partial-onset seizures. Of this total, 665 patients have been treated for more than 1 year, 177 for more than 3 years, and 67 for more than 5 years. The profile of treatment-emergent adverse reactions (TEAEs) observed with TPM at various dosages is based primarily on data from five double-blind, placebo-controlled trials in which 360 patients received TPM at target doses of 200-1,000 mg/day. Long-term safety is assessed on the basis of 1,001 patients treated with TPM in controlled and open trials for up to 5.3 years. Most of the commonly reported TEAEs were related to the central nervous system and were observed with greater frequency at dosages above the 200-600-mg/day range found to be optimal in dose ranging trials. Nephrolithiasis not requiring surgery was seen in 1.5% of patients, and mild, dose-related weight loss was associated with TPM therapy. No clinically significant treatment-related abnormalities were observed in clinical laboratory parameters or in neurologic, electrocardiographic, ophthalmologic, or audiologic tests.
[Pharmacotherapy of Vestibular Disorders, Nystagmus and Cerebellar Disorders]. [2019]There are currently different groups of drugs for the pharmacotherapy of vertigo, nystagmus and cerebellar disorders: antiemetics; anti-inflammatories, antimenieres, and antimigraineous medications and antidepressants, anticonvulsants, aminopyridines as well as acetyl-DL-leucine. In acute unilateral vestibulopathy, corticosteroids improve the recovery of peripheral vestibular function, but currently there is not sufficient evidence for a general recommendation. There is insufficient evidence to support the view that 16 mg t. i. d. or 48 mg t. i. d. betahistine has an effect in Menière's disease. Therefore, higher dosages are recommended. In animal studies, it was shown that betahistine increases cochlear blood flow. In vestibular paroxysmia, oxcarbazepine was effective (one randomized controlled trial (RCT)). Aminopyridines are recommended for the treatment of downbeat nystagmus (two RCTs) and episodic ataxia type 2 (EA2, one RCT). There has been no RCT on the efficacy of beta-blockers or topiramate but one RCT on flunarizine in vestibular migraine. Based on clinical experience, a treatment analogous to that for migraine without aura can be recommended. Acetyl-DL-leucine improved cerebellar ataxia (two observational studies); it also accelerated central compensation in an animal model of acute unilateral lesion, but RCTs were negative. There are ongoing RCTs on treatment of vestibular paroxysmia with carbamazepine (VESPA), acute unilateral vestibulopathy with betahistine (BETAVEST), vestibular migraine with metoprolol (PROVEMIG), benign paroxysmal positional vertigo with vitamin D (VitD@BPPV), EA2 with 4-aminopyridine versus acetazolamide (EAT-2-TREAT), and cerebellar ataxias with acetyl-DL-leucine (ALCAT).
[Pharmacotherapy of Vestibular Disorders, Nystagmus and Cerebellar Disorders]. [2022]There are currently different groups of drugs for the pharmacotherapy of vertigo, nystagmus and cerebellar disorders: antiemetics; anti-inflammatories, antimenieres, and antimigraineous medications and antidepressants, anticonvulsants, aminopyridines as well as acetyl-DL-leucine. In acute unilateral vestibulopathy, corticosteroids improve the recovery of peripheral vestibular function, but currently there is not sufficient evidence for a general recommendation. There is insufficient evidence to support the view that 16 mg t. i. d. or 48 mg t. i. d. betahistine has an effect in Menière's disease. Therefore, higher dosages are recommended. In animal studies, it was shown that betahistine increases cochlear blood flow. In vestibular paroxysmia, oxcarbazepine was effective (one randomized controlled trial (RCT)). Aminopyridines are recommended for the treatment of downbeat nystagmus (two RCTs) and episodic ataxia type 2 (EA2, one RCT). There has been no RCT on the efficacy of beta-blockers or topiramate but one RCT on flunarizine in vestibular migraine. Based on clinical experience, a treatment analogous to that for migraine without aura can be recommended. Acetyl-DL-leucine improved cerebellar ataxia (two observational studies); it also accelerated central compensation in an animal model of acute unilateral lesion, but RCTs were negative. There are ongoing RCTs on treatment of vestibular paroxysmia with carbamazepine (VESPA), acute unilateral vestibulopathy with betahistine (BETAVEST), vestibular migraine with metoprolol (PROVEMIG), benign paroxysmal positional vertigo with vitamin D (VitD@BPPV), EA2 with 4-aminopyridine versus acetazolamide (EAT-2-TREAT), and cerebellar ataxias with acetyl-DL-leucine (ALCAT).
Pharmacotherapy of vestibular and cerebellar disorders and downbeat nystagmus: translational and back-translational research. [2022]There are currently eight groups of drugs for the pharmacotherapy of vertigo, nystagmus, and cerebellar disorders: antiemetics; anti-inflammatories, antimenieres, and antimigraineous medications; antidepressants, anticonvulsants, aminopyridines, and acetyl-DL-leucine ("the eight A's"). In acute unilateral vestibulopathy, corticosteroids improve the recovery of peripheral vestibular function, but there is not sufficient current evidence for a general recommendation. There is also insufficient evidence that 48 or 144 mg/day betahistine has an effect in Ménière's disease. Therefore, higher dosages are currently recommended; in animal studies, it was shown that betahistine increases cochlear blood flow. In vestibular paroxysmia, oxcarbazepine was effective (one yet not randomized controlled trial (RCT)). Aminopyridines are recommended for the treatment of downbeat nystagmus (two RCTs) and episodic ataxia type 2 (EA2, one RCT). There are so far no RCTs on vestibular migraine, so currently no treatment can be recommended. Acetyl-dl-leucine improves cerebellar ataxia (three observational studies); it also accelerates central compensation in an animal model of acute unilateral lesion, but RCTs were negative. There are ongoing RCTs on vestibular paroxysmia with carbamazepine (VESPA), acute unilateral vestibulopathy with betahistine (BETAVEST), vestibular migraine with metoprolol (PROVEMIG), benign paroxysmal positional vertigo with vitamin D (VitD@BPPV), EA2 with 4-aminopyridine versus acetazolamide (EAT-2-TREAT), and cerebellar ataxias with acetyl-DL-leucine (ALCAT).