Effect of the Administration of L-arginine vs. Placebo on the vHIT Result, Vestibular Caloric Tests and Symptoms of Patients Diagnosed With Presbyvestibulopathy.

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Presbivestibulopathy is defined as a chronic vestibular syndrome characterized by bilateral vestibulopathy verified with vestibular tests. These tests objectively assess vestibular function: video Head Impulse Test (v-HIT) and Vestibular Caloric Tests. Also, there are some questionnaires that serve us for monitoring and prognosis (Dizziness Handicap Inventory). There is currently no specific treatment for presbyvestibulopathy. The objective of this study is to evaluate the effect of L-arginine vs. placebo on symptoms, changes in the results of vHIT tests of patients diagnosed with presbyvestibulopathy. It will be conducted a randomized, double blind, placebo controled clinical trial. Patients will be men and women who meet the diagnostic criteria for Presbyvestibulopathy of the Barany Society. The sample size will be 12 patients per group. The patients in the experimental group will receive L-arginine at a dose of 3 grams divided into three doses of 1 g (capsules) every 8 hours, for 3 months. Patients in the control group will receive placebo at the same dosage. All patients will receive vestibular rehabilitation exercises. At the beginning and the end of the intervention , the following tests will be carried out: vertigo disability questionnaire, vHIT tests, and the Up and Go time test.

2023-05-02

2023-11-01

2023-12-30

Withdrawn

Early phase I

Inclusion Criteria: * Men and women. * Age over 60 years. * That patient meets the diagnostic criteria established for presbyvestibulopathy by the Classification Committee of the Barany Society: * Chronic vestibular syndrome (al least 3 months duration) with at least 2 of the following symptoms: * Postural imbalance or unsteadiness * Gait disturbance * Chronic dizziness * Recurrent falls * Mild bilateral peripheral vestibular hypofunction documented by at leat 1 of the following: * VOR gain measured by video-HIT between 0.6 and 0.8 bilaterally * VOR gain between 0.1 and 0.3 upon sinusoidal stimulation on a rotatory chair (0.1 Hz, Vmax=50-60°/sec) * Reduced caloric response (sum of bithermal saccadic peak velocity (SPV) on each side between 6 and 25°/sec) * Age ≥60 years * Not better accounted for by another disease or disorder * Consent under information Exclusion Criteria: * Not being able to rule out the use of antivertigo drugs 1 week prior to study entry. * Use of vasodilator drugs or antihistamines. * Orthostatic hypotension * Cognitive deficit of the patient that prevents him from understanding the implications of the study. * Known uncontrolled liver or kidney disease. * Known hypersensitivity to study drugs. * Chronic use of drugs with an anticoagulant effect. * Bronchial asthma. Elimination Criteria: * Treatment adherence \<80% evaluated through registration in an adherence diary and capsules count * Presence of serious adverse events * Withdrawal of consent under information

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, double-blind clinical trial with a placebo control group.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Patients will be assigned by simple randomization using a table of random numbers to the pharmacological intervention groups.\n\nThe study treatment and treatment assignment codes will be kept in custody by someone outside the research team. In addition, it will be in charge of the delivery, reception and meticulous counting of the capsules to guarantee the blindness and adherence to the treatment by the patients.\n\nThis study is considered double-blind since both the principal investigator and the patient are unaware of the pharmacological intervention to which the patients will be assigned. Blinding will be possible thanks to the homologation of the drug and the placebo in both groups with capsules identical in shape, size and colour. In the same way, the medicine will be delivered in bottles of the same size, shape and color, identified only with the allocation code.\n\nThe blind may be broken in the presence of serious adverse events.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2024-02-15