Effect of the Administration of L-arginine vs. Placebo in Patients Diagnosed With Presbyvestibulopathy.

NCT ID: NCT05932979

Last Updated: 2024-02-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-02
• Study Completion Date: 2023-12-30

Brief Summary

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.

Detailed Description

Vertigo is a common cause in the otorhinolaryngology consultation; a high incidence of this condition has been reported, since there are reports indicating that up to 80% of the world population has presented an episode of vertigo at some stage of their lives.

In Germany, it has been reported a prevalence of moderate to severe vestibular vertigo is reported, calculated using a representative sample of a 22.9% in adults of 18 to 79 years. In a report of the United States Emergency Department, it has been reported that 3.3% of the first-contact consultations are due to dizziness, of which 32.9% wer of otological or vestibular origin.

Vertigo is classified into two categories: vertigo of central origin and peripheral vertigo. Peripheral vertigo, object of study of this investigation, is originated in the vestibular system, located in the inner ear. Among the differential diagnoses of vertigo of peripheral origin we find presbivestibulopathy, which is a condition characterized by bilateral vestibular dysfunction proven with objective diagnostic tests such as video HIT (vHIT), vestibular caloric tests, among others. In addition, the diagnostic must be done in people over 60 years, and other diagnostic criteria established by the diagnostic criteria for Presbyvestibulopathy of the Barany Society.

The treatment of vertigo, as well of the presbyvestibulopathy, is aimed to stabilize the pathological fluctuations in peripheral vestibular function, as well as promoting central compensation in case of a permanent deficit in vestibular function. Therefore, the drugs used for its treatment their purpose is to regulate the decompensated vestibular activity and to improve the symptoms, but not to suppress the cause that originates the pathology since the mechanism of action of the disease is not well established.

Currently, there is not a first-choice medication for the treatment of vertigo in general, much less for presbyvestibulopathy, since none has show high efficacy and low presence of adverse effects.

Some of the drugs used to treat vertigo include anticholinergics, antihistamines, benzodiazepines and calcium channel blockers.

In the same way, some substances have been used that have shown effectiveness despite the fact that their mechanism of action is unknown or not very clear, sus as betahistine and Gingko biloba.

L-arginine is a precursor amino acid fr the endogenous synthesis of nitric oxide (NO), a molecule produced in the vascular endothelium with vasodilatory, antiatherogenic and antiplatelet action.

To date, there is no evidence of the use of L-arginine for the treatment of vertigo, however, its vasodilator effect as a precursor of NO should favor vascular perfusion in the vestibular system, therefore, it is of interest to know the therapeutic effects of L-arginine for ths treatment of pathology.

Conditions

Presbyvestibulopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

L-arginine

L-arginine 3 grams per day, divided into doses of 1 g every 8 hours during 90 days.

Group Type: EXPERIMENTAL

L-arginine

Intervention Type: DRUG

L-arginine 2-amino-5-guanidino-pentanoic acid is a proteinogenic amino acid that is a natural constituent of the protein diet.

Placebo

Starch 1 gr every 8hr, during 90 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Starch

Interventions

L-arginine

L-arginine 2-amino-5-guanidino-pentanoic acid is a proteinogenic amino acid that is a natural constituent of the protein diet.

Intervention Type: DRUG

Placebo

Starch

Intervention Type: OTHER

Other Intervention Names

Arginine; Starch

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro Universitario de Tonalá

OTHER

Sponsor Role: lead

Responsible Party

Martha De Nuestra Señora De San Juan Rodríguez Sahagún

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martha de Nuestra Señora de San Juan Rodríguez, MD

Role: PRINCIPAL_INVESTIGATOR

CUTonalá

Locations

CUTonalá

Tonalá, Jalisco, Mexico

Countries

Mexico

References

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Other Identifiers

160/22

Identifier Type: -

Identifier Source: org_study_id