BETAHISTINE DIHYDROCHLORIDE for Meniere's disease

Inclusion criteria

• {"criterion_text":"- Male or non-pregnant female patients ≥18 years of age.\n- Patient has a diagnosis of unilateral definite Meniere's disease by 1995 American Academy of Otolaryngology — Head and Neck Surgery (AAOHNS) criteria and reports history of frequent attacks of active vertigo on betahistine (soon after the start of an acute attack of vertigo) prior to the study lead-in/wash-out period\n- Patient as •\t a naïve patient who has experienced active vertigo of significant severity (defined as a score ≥7 points according to Intensity (V), Duration (D) and Frequency of the crisis (F) ítems of the GISFaV self-rating scale) during the month prior to inclusion in the trial •\tor a pretreated patient with betahistine IR <48 mg/day who has experienced active vertigo of significant severity (defined as a score ≥5 points according to Intensity (V), Duration (D) and Frequency of the crisis (F) ítems of the GISFaV self-rating scale) during the month prior to inclusion in the trial •\tor a pretreated patient with betahistine IR = 48 mg/day who has experienced active vertigo of any severity during the month prior to inclusion in the trial\n- Patient has documented asymmetric sensorineural hearing loss.\n- Patients currently on a low salt diet at the time of screening agree to continue this low-salt diet throughout the study.\n- Patients who withdrawal of interfering concomitant therapies at least 7 days before the start of the study treatment. The following are considered concomitant therapies: other agents for peripheral vestibular vertigo (diuretics, trans tympanic gentamycin, cinnarizine, competitive antagonist of histamine, blocking H1- histamine receptors), drugs that act on cerebral circulation, antihistamines, calcium antagonists, antiagregant, thiazide diuretics, corticosteroids and benzodiazepines.\n- Women with child-bearing potential should have a negative serum pregnancy test at screening visit at the start of the treatment. Such females and their partners should be ready to adopt required measures to avoid conception throughout the study participation. Detailed information in section 8.1.7\n- Informed consent as obtained in Section 11.3 of the protocol."}

Exclusion criteria

• {"criterion_text":"- Patient is pregnant or lactating.\n- Patient with middle or inner ear infection.\n- Patient with history of middle or inner ear surgery.\n- Paciente con antecedentes o presencia de alcoholismo significativo o abuso de drogas en el último año.\n- Patients with psychiatric or significant neurological disorders, spinal cord damage, use of any other agents for Meniere's disease.\n- Patients with ear surgery for vestibular disorders.\n- Patients with peptic ulcer (including a history of this disorder).\n- Patient has a history of immunodeficiency disease.\n- Patient has a history of previous endolymphatic sac surgery.\n- Patient has a history of previous use of intratympanic (IT) gentamicin in the affected ear.\n- History of tympanostomy tubes with evidence of perforation or lack of closure.\n- Patient has experienced an adverse reaction to IT injection of steroids.\n- Patient has used an investigational drug or device in 3 months prior to screening.\n- Patients with hypersensitivity to the active substance or to any of the excipients of the study drug.\n- Patients with pheochromocytoma.\n- Patients with asthmatic bronchitis, bronchial asthma, urticaria, exanthema or allergic rhinitis.\n- Patients with pronounced hypotension.\n- Patients under treatment with MAO inhibitors (including MAO-B selective).\n- Patients with any major medical or surgical condition likely to interfere with the absorption, distribution, metabolism or excretion of the drug used in the study or with a terminal disease.\n- Patients with vestibular disorders other than Meniere’s disease such as benign paroxysmal positional vertigo perilymph fistula, vestibular neuronitis, viral labyrinthitis, benign paroxysmal vertigo of childhood, otosclerosis, giddiness of ischemic or neck origin together with a sensorineural hearing loss, cholesteatoma and fistula formation, disequilibrium after head injury, drug toxicity, vestibular neuroma, multiple sclerosis, cardiovascular disturbances, craniocervical dysplasia, syphilis and Cogan's syndrome"}

Primary endpoints

• {"endpoint_text":"- Percentage of significant responders defined as those patients who present a maximum increase of 1 point in two of the intensity, duration or frequency of vertigo attacks score based on GISFaV scale against baseline score registered during patient inclusion.","definition_or_measurement_approach":"Determined using the GISFaV self-rating scale vs baseline recorded at inclusion; responders defined as maximum increase of 1 point in two of intensity, duration or frequency items on GISFaV."}
• {"endpoint_text":"- GISFaV self-rating scale involving each item separately for determination of the disturbance stage of vertigo using values of intensity (V: 4-point scale), duration (D: A 5-point scale) and associated symptoms (N: A 3-point scale), frequency of crisis (F: A 5-point scale), quality of life (Q: A 3-point scale) scored respectively.","definition_or_measurement_approach":"Each GISFaV item scored separately (V: 4-point, D: 5-point, N: 3-point, F: 5-point, Q: 3-point); used to determine disturbance stage of vertigo and component scores."}

Secondary endpoints

• {"endpoint_text":"- Number of asymptomatic days (no vertigo attacks) during treatment period.","definition_or_measurement_approach":"Count of days without vertigo attacks during the treatment period as recorded in patient diaries/assessments."}
• {"endpoint_text":"- Patient rates with all the GISFaV items equal to 0 at 3 months.","definition_or_measurement_approach":"Proportion of patients with all GISFaV item scores = 0 at month 3 visit."}
• {"endpoint_text":"- Change in number of monthly vertigo attacks during treatment period.","definition_or_measurement_approach":"Difference in monthly count of vertigo attacks from baseline to during treatment period."}
• {"endpoint_text":"- Data of rescue medications used during treatment period","definition_or_measurement_approach":"Recording and summarisation of rescue medication use (type, frequency) during treatment."}
• {"endpoint_text":"- Percentage of significant responders defined by 1-point change in any two of intensity, duration and frequency of vertigo attacks score based on GISFaV scale against baseline score registered during patient inclusion in the subgroups of naive patients or pretreated patient with betahistine IR <48 mg/day","definition_or_measurement_approach":"Subgroup analysis of responders (1-point change in any two of intensity/duration/frequency by GISFaV) for naïve vs pretreated (<48 mg/day) patients compared to baseline."}
• {"endpoint_text":"- The Dizziness Handicap Inventory (DHI) rating scale for the identification of the difficulties that patients encounter during the vertiginous disease.","definition_or_measurement_approach":"DHI scoring as per standard Dizziness Handicap Inventory to assess functional/emotional/physical impact."}
• {"endpoint_text":"- Hearing will be scored as: 'good', 'slightly impaired', 'moderately impaired' or 'seriously impaired'. In addition, the patient will be asked to note whether s/he felt that her/his hearing was 'better', 'the same' or 'worse' than the week before or was 'fluctuating'.","definition_or_measurement_approach":"Categorical scoring of hearing status and patient-reported change relative to previous week; used to evaluate hearing outcome."}
• {"endpoint_text":"- Tinnitus will be scored as: 'none', 'mild', 'moderate' or 'severe'.","definition_or_measurement_approach":"Categorical scoring of tinnitus severity as reported by patient."}
• {"endpoint_text":"- Pressure sensation will be scored as 'none', 'mild', 'moderate' or 'severe'.","definition_or_measurement_approach":"Categorical scoring of pressure sensation related to disease as reported by patient."}
• {"endpoint_text":"- At the end of the study, the investigators’ and patients’ overall judgments respectively on treatment efficacy and acceptance (five-point scale: 0= null, 1= poor, 2= moderate, 3= good, 4= very good) and the doctor’s preparedness to treat the patient again with the same treatment","definition_or_measurement_approach":"Five-point global assessment by investigators and patients on efficacy and acceptance; investigator question on willingness to treat again with same treatment."}

Spain

Earliest CTIS Part Ii Submission Date

24-09-2024

Latest Decision Or Authorization Date

09-12-2025

Processing Time Days

435

Number Of Sites

8

Number Of Participants

328

Primary sponsor

Full Name

Intas Pharmaceuticals Limited

Organisation Type

Pharmaceutical company

Country Of Registered Address

India

Contract research organisations

Name

Novotech Clinical Research (Cyprus) Limited

Responsibilities

Sponsor duties codes: 1, 12, 2, 5 (as listed in CTIS)

Name

Lambda Therapeutic Research Limited

Responsibilities

Biostatistics, Report Writing, Medical services, Quality Assurance and Pharmacovigilance (as listed)

Third parties

• {"country":"Cyprus","full_name":"Novotech Clinical Research (Cyprus) Limited","duties_or_roles":"sponsorDuties codes: 1, 12, 2, 5 (roles as provided in CTIS entry)","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Ardena Pamplona S.L.","duties_or_roles":"EU packaging, test and release of the medication","organisation_type":"Pharmaceutical company"}
• {"country":"India","full_name":"Lambda Therapeutic Research Limited","duties_or_roles":"Biostatistics, Report Writing, Medical services, Quality Assurance and Pharmacovigilance (and other study support functions as listed)","organisation_type":"Pharmaceutical company"}