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Trial record 18 of 215 for:    Lamotrigine

Study of Lamotrigine to Treat Ménière's Disease

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ClinicalTrials.gov Identifier: NCT02158585
Recruitment Status : Completed
First Posted : June 9, 2014
Last Update Posted : July 28, 2017
Sponsor:
Collaborators:
University at Buffalo
Ernesto Diaz-Ordaz, MD
Information provided by (Responsible Party):
Lixin Zhang, Dent Neuroscience Research Center

Brief Summary:
This double-blinded study evaluates the frequency of vertigo attacks and the quality of life of patients diagnosed with Ménière's disease after being randomly assigned to take a placebo or lamotrigine.

Condition or disease Intervention/treatment Phase
Meniere's Disease Ménière's Vertigo Vertigo, Intermittent Vertigo, Aural Drug: Lamotrigine Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lamotrigine for Ménière's Disease: a Double-blind, Placebo-controlled Pilot Study
Study Start Date : June 2014
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Lamotrigine

Arm Intervention/treatment
Placebo Comparator: Placebo
The placebo will match the lamotrigine dosage, frequency and duration.
Drug: Placebo
The placebo will match the lamotrigine dosage, frequency and duration.
Other Name: microcrystalline cellulose

Active Comparator: Lamotrigine
Lamotrigine will be taken orally for the duration of 20 weeks, consisting of a six-week titration, 12-week study period, and two-week taper. Possible doses are 25mg twice a day, 50mg twice a day, 100 mg twice a day and 150mg twice a day during titration; 150mg twice a day or 100mg twice a day for the 12-week study period; 150mg once a day, or 100mg once a day for Week 1 of the taper; and 75mg once a day, or 50mg once a day for Week 2 of the taper. Patients who withdraw at any point of the study will have a two-week taper consisting of the current dose once a day for one week followed by half the dose once a day for another week.
Drug: Lamotrigine
Lamotrigine will be taken orally on a daily basis for the duration of 20 weeks, consisting of a six-week titration, 12-week study period, and two-week taper. Possible doses for patients are 25mg twice a day, 50mg twice a day, 100 mg twice a day and 150mg twice a day during titration; 150mg twice a day or 100mg twice a day for the 12-week study period; 150mg once a day or 100mg once a day for Week 1 of the taper; and 75mg once a day, or 50mg once a day for Week 2 of the taper. Each increase in dose will be maintained for two weeks before deciding to further increase or decrease based on tolerability. Patients who discontinue at any point of the study will have a two-week taper consisting of the current dose once a day for one week followed by half the dose once a day for another week.
Other Names:
  • Lamictal
  • 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine
  • U3H27498KS




Primary Outcome Measures :
  1. Change in Ménière's vertigo attack frequency [ Time Frame: Duration of 4-week lead-in, duration of the 6-week titration, duration of the 12-week study period ]
    Measured with a daily questionnaire


Secondary Outcome Measures :
  1. Responder rate [ Time Frame: End of study period (Week 22) ]
    Percentage of patients with > 50% reduction in vertigo attack frequency from baseline at end of lead-in period to end of study period

  2. Change in length of vertigo attack-free intervals [ Time Frame: Duration of 4-week lead-in, duration of the 6-week titration, duration of the 12-week study period ]
    Measured with a daily questionnaire

  3. Change in hearing loss [ Time Frame: Screening (Visit 1, week 0), end of titration (Visit 5, week 10), end of study period (Visit 8, week 22) ]
  4. Change in symptom severity scores on the Ménière's Disease Patients-Oriented Severity Index (MDPOSI) [ Time Frame: Visit 1 (week 0), Visit 2 (week 4), Visit 3 (week 6), Visit 4 (week 8), Visit 5 (week 10), Visit 6 (week 14), Visit 7 (week 18), Visit 8 (Week 22) ]
  5. Change in Tinnitus Handicap Inventory (THI) score [ Time Frame: Visit 1 (week 0), Visit 2 (week 4), Visit 3 (week 6), Visit 4 (week 8), Visit 5 (week 10), Visit 6 (week 14), Visit 7 (week 18), Visit 8 (Week 22) ]
  6. Rating of Meniere's disease severity on the Clinical Global Impression Scale [ Time Frame: Screening (Visit 1, week 0) ]
  7. Change in Dizziness Handicap Inventory (DHI) score [ Time Frame: Visit 1 (week 0), Visit 2 (week 4), Visit 3 (week 6), Visit 4 (week 8), Visit 5 (week 10), Visit 6 (week 14), Visit 7 (week 18), Visit 8 (Week 22) ]
  8. Change in rating of symptom impact on daily life on the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) Ménière's disease self-assessment [ Time Frame: Visit 1 (week 0), Visit 2 (week 4), Visit 3 (week 6), Visit 4 (week 8), Visit 5 (week 10), Visit 6 (week 14), Visit 7 (week 18), Visit 8 (Week 22) ]
  9. Change in number and percentage of vertigo attack-free days per 28 days period [ Time Frame: Duration of 4-week lead-in, duration of the 6-week titration, duration of the 12-week study period ]
    Measured with a daily questionnaire

  10. Change in number and percentage of patients who are vertigo attack-free [ Time Frame: Duration of the 6-week titration, duration of the 12-week study period ]
    Measured with a daily questionnaire

  11. Rating of drug effect on the Clinical Global Impression Scale [ Time Frame: End of study period (Visit 8, Week 22) ]
  12. Rating of total improvement on the Clinical Global Impression Scale [ Time Frame: End of study period (Visit 8, week 22) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female participants aged 18 years or older
  • Diagnosed with unilateral definite Ménière's disease according to the AAO-HNS 1995 criteria, confirmed by an ENT
  • Active vertigo: at least two Ménière's vertigo attacks (defined as lasting 20 minutes or longer and associated with tinnitus, ear fullness, or low frequency hearing loss and nausea/vomiting) every four weeks during the eight-week qualification period and at least two more Ménière's vertigo attacks during the lead-in phase prior to randomization
  • Documented unilateral lower frequency hearing loss defined as the four-tone average (arithmetic mean rounded to the nearest whole number) of the pure-tone thresholds at 0.25, 0.5, 1 and 2 kilohertz (kHz) more than or equal to 25 decibels (dB) of the worse audiogram during the six months before screening
  • Have tried diuretics for at least one month and discontinued treatment due to continued vertigo attacks
  • All other co-existing medical or psychiatric conditions are stable, and no greater than moderate severity
  • Willing to avoid pregnancy during the entirety of the study (abstinence or two forms of acceptable birth control, such as condoms and oral contraceptives)

Exclusion Criteria:

  • Bilateral Ménière's disease
  • Current or past history of migraine
  • Any other neuro-otologic disease or major vestibular abnormality found during screening that could confound the evaluation of Ménière's symptoms
  • Previous intolerance or sensitivity to lamotrigine
  • On any prohibited medication within four weeks prior to the study
  • History of tympanostomy tubes with evidence of perforation or lack of closure
  • IT gentamicin injections or endolymphatic sac surgery within the last year
  • History of or current immunodeficiency disease, nephrolithiasis, hypertension, cardiac disease, arrhythmia, hypercholesterolemia, hemiplegic/basilar migraine, stroke, diabetes, vascular disease or kidney disease
  • Family history of unexplained deafness
  • Pregnant or breastfeeding
  • Current diseases or conditions that may be associated with an altered perception of processing stimuli
  • Current severe medical condition(s) that in the view of the investigator prohibits participation
  • Previously used the investigational drug
  • Current non-vertiginous dizziness (orthostatic or panic disorder) unless it could be clearly differentiated from Ménière's attacks by the participant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02158585


Locations
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United States, New York
Dent Neurologic Institute
Amherst, New York, United States, 14226
Sponsors and Collaborators
Dent Neuroscience Research Center
University at Buffalo
Ernesto Diaz-Ordaz, MD
Investigators
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Principal Investigator: Lixin Zhang, MD, PhD Dent Neurologic Institute

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Responsible Party: Lixin Zhang, Medical Director of the Dizziness and Balance Center, Dent Neuroscience Research Center
ClinicalTrials.gov Identifier: NCT02158585     History of Changes
Other Study ID Numbers: Zhang-001
First Posted: June 9, 2014    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017
Keywords provided by Lixin Zhang, Dent Neuroscience Research Center:
Lamotrigine
Lamictal
Anticonvulsant
Ménière's disease
Vertigo attack
Dizziness
Vestibular disorder
Additional relevant MeSH terms:
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Lamotrigine
Vertigo
Meniere Disease
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders
Endolymphatic Hydrops
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Sodium Channel Blockers