PresbyvestibulopathyPhase 2L-ARGPRESNCT05932979
Effect of the Administration of L-arginine vs. Placebo in Patients Diagnosed With Presbyvestibulopathy.
A Phase 2 study testing L-arginine in people with Presbyvestibulopathy, run by Centro Universitario de Tonalá at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Presbyvestibulopathy
- What is being tested?
- L-arginine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- 2 May 2023to 30 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Administration of L-arginine vs. Placebo on the vHIT Result, Vestibular Caloric Tests and Symptoms of Patients Diagnosed With Presbyvestibulopathy.
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.
Read the 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
- Being tested
- L-arginine, Placebo
- Keywords
- L-arginine, Presbyvestibulopathy, Vertigo, v-HIT
- Medical subject headings
- Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-arginineDrug
Also called Arginine
L-arginine 2-amino-5-guanidino-pentanoic acid is a proteinogenic amino acid that is a natural constituent of the protein diet.
PlaceboOther
Also called Starch
Starch
| Study group | Role | What they receive |
|---|---|---|
| L-arginine | Experimental | L-arginine 3 grams per day, divided into doses of 1 g every 8 hours during 90 days. Receives: Drug: L-arginine |
| Placebo | Placebo comparator | Starch 1 gr every 8hr, during 90 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Video Head Impulse Test vHIT
The vHIT is a simple, rapid test to assess vestibular function. It is based on the physiological aspects of the vestibular ocular reflex (VOR). VOR is a rapid reflex with a duration of 7 to 10 milliseconds and consists of the ability to keep the gaze fixed on an object with rapid and unexpected movements of the head.
This study has a specificity and sensitivity of 100% to evaluate the VOR.
Measured: Pre-intervention
Final Video Head Impulse Test vHIT
The vHIT is a simple, rapid test to assess vestibular function. It is based on the physiological aspects of the vestibular ocular reflex (VOR). VOR is a rapid reflex with a duration of 7 to 10 milliseconds and consists of the ability to keep the gaze fixed on an object with rapid and unexpected movements of the head.
This study has a specificity and sensitivity of 100% to evaluate the VOR.
Measured: Final (after 90 days of intervention)
Baseline Dizziness Handicap Inventory
Questionnaire that helps us to know the degree of emotional, functional and physical disability of patients diagnosed with presbyvestibulopathy. In addition, it has been used by different authors as a prognostic value, to know the improvement of pre- and post-treatment patients.
Measured: Pre-intervention
Final Dizziness Handicap Inventory
Questionnaire that helps us to know the degree of emotional, functional and physical disability of patients diagnosed with presbyvestibulopathy. In addition, it has been used by different authors as a prognostic value, to know the improvement of pre- and post-treatment patients.
Measured: Final (after 90 days of intervention)
Secondary outcomes (5)
Baseline Time up and go Test
It is a simple test that consists of a patient being asked to stand up without support while sitting in a chair without armrests and walk forward for 3 meters and back, the time it takes to do so is timed. Most authors consider that if the duration is greater than 10 seconds, there is a greater risk of falls.
Measured: Pre-intervention
Final Time up and go Test
It is a simple test that consists of a patient being asked to stand up without support while sitting in a chair without armrests and walk forward for 3 meters and back, the time it takes to do so is timed. Most authors consider that if the duration is greater than 10 seconds, there is a greater risk of falls.
Measured: Final (after 90 days of intervention)
Adverse events
Adverse events will be evaluated through a diary in which patients will record any adverse event presented between visits. Also, it will be verified with direct interview.
Measured: Final (after 90 days of intervention)
Initial Audiometry
Audiometry aims to make a graphic record of hearing which is called audiogram. This study help us to detect hearing loss and classiffy it according to its site of origin.
Measured: Pre-intervention
Final Audiometry
Audiometry aims to make a graphic record of hearing which is called audiogram. This study help us to detect hearing loss and classiffy it according to its site of origin.
Measured: Final (after 90 days of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start2 May 2023
- Primary completion1 Nov 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Why it stopped: the investigation was cancelled because there was no monetary resource to complete it.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for PresbyvestibulopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind clinical trial with a placebo control group.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitario de Tonalá
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha De Nuestra Señora De San Juan Rodríguez Sahagún, Centro Universitario de Tonalá
- Investigators
- Martha de Nuestra Señora de San Juan Rodríguez, MD, Principal investigator, CUTonalá
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932979
- Sponsor's protocol ID
- 160/22
- Acronym
- L-ARGPRES
- Status last verified
- Feb 2024
- First submitted
- 12 May 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agrawal Y, Van de Berg R, Wuyts F, Walther L, Magnusson M, Oh E, Sharpe M, Strupp M. Presbyvestibulopathy: Diagnostic criteria Consensus document of the classification committee of the Barany Society. J Vestib Res. 2019;29(4):161-170. doi: 10.3233/VES-190672.
PubMed 31306146Aggarwal NT, Bennett DA, Bienias JL, Mendes de Leon CF, Morris MC, Evans DA. The prevalence of dizziness and its association with functional disability in a biracial community population. J Gerontol A Biol Sci Med Sci. 2000 May;55(5):M288-92. doi: 10.1093/gerona/55.5.m288.
PubMed 10819319Alrwaily M, Whitney SL. Vestibular rehabilitation of older adults with dizziness. Otolaryngol Clin North Am. 2011 Apr;44(2):473-96, x. doi: 10.1016/j.otc.2011.01.015.
PubMed 21474018Bai Y, Sun L, Yang T, Sun K, Chen J, Hui R. Increase in fasting vascular endothelial function after short-term oral L-arginine is effective when baseline flow-mediated dilation is low: a meta-analysis of randomized controlled trials. Am J Clin Nutr. 2009 Jan;89(1):77-84. doi: 10.3945/ajcn.2008.26544. Epub 2008 Dec 3.
PubMed 19056561Rodrigues DL, Ledesma ALL, Pires de Oliveira CA, Bahmad F Jr. Effect of Vestibular Exercises Associated With Repositioning Maneuvers in Patients With Benign Paroxysmal Positional Vertigo: A Randomized Controlled Clinical Trial. Otol Neurotol. 2019 Sep;40(8):e824-e829. doi: 10.1097/MAO.0000000000002324.
PubMed 31356483Dong JY, Qin LQ, Zhang Z, Zhao Y, Wang J, Arigoni F, Zhang W. Effect of oral L-arginine supplementation on blood pressure: a meta-analysis of randomized, double-blind, placebo-controlled trials. Am Heart J. 2011 Dec;162(6):959-65. doi: 10.1016/j.ahj.2011.09.012. Epub 2011 Nov 8.
PubMed 22137067Rosengren SM, Young AS, Taylor RL, Welgampola MS. Vestibular function testing in the 21st century: video head impulse test, vestibular evoked myogenic potential, video nystagmography; which tests will provide answers? Curr Opin Neurol. 2022 Feb 1;35(1):64-74. doi: 10.1097/WCO.0000000000001023.
PubMed 34889807Scholtz AW, Hahn A, Stefflova B, Medzhidieva D, Ryazantsev SV, Paschinin A, Kunelskaya N, Schumacher K, Weisshaar G. Efficacy and Safety of a Fixed Combination of Cinnarizine 20 mg and Dimenhydrinate 40 mg vs Betahistine Dihydrochloride 16 mg in Patients with Peripheral Vestibular Vertigo: A Prospective, Multinational, Multicenter, Double-Blind, Randomized, Non-inferiority Clinical Trial. Clin Drug Investig. 2019 Nov;39(11):1045-1056. doi: 10.1007/s40261-019-00858-6.
PubMed 31571128Sokolova L, Hoerr R, Mishchenko T. Treatment of Vertigo: A Randomized, Double-Blind Trial Comparing Efficacy and Safety of Ginkgo biloba Extract EGb 761 and Betahistine. Int J Otolaryngol. 2014;2014:682439. doi: 10.1155/2014/682439. Epub 2014 Jun 25.
PubMed 25057270Agrawal Y, Zuniga MG, Davalos-Bichara M, Schubert MC, Walston JD, Hughes J, Carey JP. Decline in semicircular canal and otolith function with age. Otol Neurotol. 2012 Jul;33(5):832-9. doi: 10.1097/MAO.0b013e3182545061.
PubMed 22699991
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Administration of L-arginine vs. Placebo on the vHIT Result, Vestibular Caloric Tests and Symptoms of Patients Diagnosed With Presbyvestibulopathy.
- ClinicalTrials.gov ID
- NCT05932979
- Acronym / sponsor ID
- L-ARGPRES / 160/22
- Conditions
- Presbyvestibulopathy
- Keywords
- L-arginine, Presbyvestibulopathy, Vertigo, v-HIT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the investigation was cancelled because there was no monetary resource to complete it.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centro Universitario de TonaláUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind clinical trial with a placebo control group.
| Arm | Type | Receives |
|---|---|---|
| L-arginine | Experimental | Drug: L-arginineL-arginine 3 grams per day, divided into doses of 1 g every 8 hours during 90 days. |
| Placebo | Placebo comparator | Other: PlaceboStarch 1 gr every 8hr, during 90 days. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Men and women.
- Age over 60 years.
- That patient meets the diagnostic criteria established for presbyvestibulopathy by the Classification Committee of the Barany Society:
- Consent under information
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-arginineAlso: ArginineL-arginine 2-amino-5-guanidino-pentanoic acid is a proteinogenic amino acid that is a natural constituent of the protein diet. | Drug | L-arginine |
| PlaceboAlso: StarchStarch | Other | Placebo |
Primary outcome
Baseline Video Head Impulse Test vHIT
Time frame: Pre-intervention
The vHIT is a simple, rapid test to assess vestibular function. It is based on the physiological aspects of the vestibular ocular reflex (VOR). VOR is a rapid reflex with a duration of 7 to 10 milliseconds and consists of the ability to keep the gaze fixed on an object with rapid and unexpected movements of the head. This study has a specificity and sensitivity of 100% to evaluate the VOR.
Final Video Head Impulse Test vHIT
Time frame: Final (after 90 days of intervention)
The vHIT is a simple, rapid test to assess vestibular function. It is based on the physiological aspects of the vestibular ocular reflex (VOR). VOR is a rapid reflex with a duration of 7 to 10 milliseconds and consists of the ability to keep the gaze fixed on an object with rapid and unexpected movements of the head. This study has a specificity and sensitivity of 100% to evaluate the VOR.
Baseline Dizziness Handicap Inventory
Time frame: Pre-intervention
Questionnaire that helps us to know the degree of emotional, functional and physical disability of patients diagnosed with presbyvestibulopathy. In addition, it has been used by different authors as a prognostic value, to know the improvement of pre- and post-treatment patients.
Final Dizziness Handicap Inventory
Time frame: Final (after 90 days of intervention)
Questionnaire that helps us to know the degree of emotional, functional and physical disability of patients diagnosed with presbyvestibulopathy. In addition, it has been used by different authors as a prognostic value, to know the improvement of pre- and post-treatment patients.
5 secondary outcomes
Baseline Time up and go Test
Time frame: Pre-intervention
Final Time up and go Test
Time frame: Final (after 90 days of intervention)
Adverse events
Time frame: Final (after 90 days of intervention)
Initial Audiometry
Time frame: Pre-intervention
Final Audiometry
Time frame: Final (after 90 days of intervention)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Background: PubMed 31306146Agrawal Y, Van de Berg R, Wuyts F, Walther L, Magnusson M, Oh E, Sharpe M, Strupp M. Presbyvestibulopathy: Diagnostic criteria Consensus document of the classification committee of the Barany Society. J Vestib Res. 2019;29(4):161-170. doi: 10.3233/VES-190672.
- Background: PubMed 10819319Aggarwal NT, Bennett DA, Bienias JL, Mendes de Leon CF, Morris MC, Evans DA. The prevalence of dizziness and its association with functional disability in a biracial community population. J Gerontol A Biol Sci Med Sci. 2000 May;55(5):M288-92. doi: 10.1093/gerona/55.5.m288.
- Background: PubMed 21474018Alrwaily M, Whitney SL. Vestibular rehabilitation of older adults with dizziness. Otolaryngol Clin North Am. 2011 Apr;44(2):473-96, x. doi: 10.1016/j.otc.2011.01.015.
- Background: PubMed 19056561Bai Y, Sun L, Yang T, Sun K, Chen J, Hui R. Increase in fasting vascular endothelial function after short-term oral L-arginine is effective when baseline flow-mediated dilation is low: a meta-analysis of randomized controlled trials. Am J Clin Nutr. 2009 Jan;89(1):77-84. doi: 10.3945/ajcn.2008.26544. Epub 2008 Dec 3.
- Background: PubMed 31356483Rodrigues DL, Ledesma ALL, Pires de Oliveira CA, Bahmad F Jr. Effect of Vestibular Exercises Associated With Repositioning Maneuvers in Patients With Benign Paroxysmal Positional Vertigo: A Randomized Controlled Clinical Trial. Otol Neurotol. 2019 Sep;40(8):e824-e829. doi: 10.1097/MAO.0000000000002324.
- Background: PubMed 22137067Dong JY, Qin LQ, Zhang Z, Zhao Y, Wang J, Arigoni F, Zhang W. Effect of oral L-arginine supplementation on blood pressure: a meta-analysis of randomized, double-blind, placebo-controlled trials. Am Heart J. 2011 Dec;162(6):959-65. doi: 10.1016/j.ahj.2011.09.012. Epub 2011 Nov 8.
- Background: PubMed 34889807Rosengren SM, Young AS, Taylor RL, Welgampola MS. Vestibular function testing in the 21st century: video head impulse test, vestibular evoked myogenic potential, video nystagmography; which tests will provide answers? Curr Opin Neurol. 2022 Feb 1;35(1):64-74. doi: 10.1097/WCO.0000000000001023.
- Background: PubMed 31571128Scholtz AW, Hahn A, Stefflova B, Medzhidieva D, Ryazantsev SV, Paschinin A, Kunelskaya N, Schumacher K, Weisshaar G. Efficacy and Safety of a Fixed Combination of Cinnarizine 20 mg and Dimenhydrinate 40 mg vs Betahistine Dihydrochloride 16 mg in Patients with Peripheral Vestibular Vertigo: A Prospective, Multinational, Multicenter, Double-Blind, Randomized, Non-inferiority Clinical Trial. Clin Drug Investig. 2019 Nov;39(11):1045-1056. doi: 10.1007/s40261-019-00858-6.
- Background: PubMed 25057270Sokolova L, Hoerr R, Mishchenko T. Treatment of Vertigo: A Randomized, Double-Blind Trial Comparing Efficacy and Safety of Ginkgo biloba Extract EGb 761 and Betahistine. Int J Otolaryngol. 2014;2014:682439. doi: 10.1155/2014/682439. Epub 2014 Jun 25.
- Background: PubMed 22699991Agrawal Y, Zuniga MG, Davalos-Bichara M, Schubert MC, Walston JD, Hughes J, Carey JP. Decline in semicircular canal and otolith function with age. Otol Neurotol. 2012 Jul;33(5):832-9. doi: 10.1097/MAO.0b013e3182545061.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha de Nuestra Señora de San Juan Rodríguez, MD principal investigator
CUTonalá
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing L-arginine in people with Presbyvestibulopathy, run by Centro Universitario de Tonalá at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Video Head Impulse Test vHIT (time frame: Pre-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05932979, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.