DizzinessNCT02592863
Trental for the Treatment of Vertigo/Dizziness/Imbalance
A study testing Pentoxifylline in people with Dizziness and Vertigo, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
Imbalance, dizziness and vertigo as a result of problems in the inner ear (vestibular dysfunction) are becoming increasingly more prevalent in Americans 40 years of age and older. The symptoms have a severe impact on affected individuals with detrimental effects on work, travel, social and family life. Read more about this study
- Who is it for?
- Ages 40 years and older
- What is being tested?
- Pentoxifylline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 12 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 40 years and older
- English as primary language
- Diagnosis of multisensory losses, presbystasis, bilateral vestibulopathy, central vascular insufficiency, small vessel circulatory disease, generalized imbalance, and idiopathic peripheral vertigo scoring at least 16 on the Dizziness Handicap Inventory
- Willingness to complete surveys and take medication as prescribed
Who cannot join
- Diagnosis of the following: benign paroxysmal positional vertigo, Meniere's disease, vestibular migraine with headache, intracranial mass, perilymphatic fistula, or multiple sclerosis
- history of cholesteatoma
- Prior ear surgery other than myringotomy and tube placement
- Prior radiation to head or neck
- previous use of vestibulotoxic medications where the enrolling provider determines the drug exposure to be the cause of imbalance
- Use of blood thinning medications
- intolerance/allergy to pentoxifylline or methylxanthines, as well as recent cerebral or retinal hemorrhage (past 3 months)
- Pregnant or lactating females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomized Trial of Pentoxifylline for Imbalance Secondary to Insufficient Microvascular Perfusion
Imbalance, dizziness and vertigo as a result of problems in the inner ear (vestibular dysfunction) are becoming increasingly more prevalent in Americans 40 years of age and older. The symptoms have a severe impact on affected individuals with detrimental effects on work, travel, social and family life. These patients see doctors often with no relief in their symptoms.
The most promising help for these patients is to use medication that will increase blood flow to the inner ear. Pentoxifylline (Trental) has been shown to increase microvascular blood flow.
Read the detailed description
One potential cause of vestibular dysfunction is a decrease in or insufficient blood flow to the inner ear. Studies have shown that when the blood flow is decreased to the inner ear, patients will become dizzy and off balance. This study will use validated instruments to evaluate the effectiveness of Trental in patients that present to our providers with vertigo, dizziness, or imbalance and meet inclusion criteria. They will be blinded and randomized to treatment or placebo, which they will take for ~12 weeks. Patients will completed validated surveys 3 times (beginning, middle and end of study) as well as account for the number of times they have fallen and if they have missed any work due to their symptoms.
- Being tested
- Pentoxifylline, Placebo
- Medical subject headings
- Dizziness, Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentoxifyllineDrug
Also called Trental
Patients will take Trental (Pentoxifylline) 3 times per day for 12 weeks
PlaceboDrug
Patients will take placebo 3 times per day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pentoxifylline | Experimental | Patients will take Trental (Pentoxifylline) 3 times per day for 12 weeks Receives: Drug: Pentoxifylline |
| Placebo | Placebo comparator | Patients will take placebo 3 times per day for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Trental Treatment Using the Dizziness Handicap Inventory, Vestibular Activities and Participation, and European Evaluation of Vertigo Scale
The Dizziness Handicap Inventory (DHI) is 25 question self report questionnaire that measures how dizziness affects a person's daily life. The questions are grouped into three domains: physical (P), emotional (E), and functional (F). Each question has three possible answers: "Always", "Sometimes", or "No". The answers are worth points, with "Always" being worth 4 points, "Sometimes" worth 2 points, and "No" worth 0 points. After answering all the questions, the total score is calculated, ranging from 0 to 100 points. A higher score indicates a more severe handicap, with 0 points indicating no effect and 100 points indicating maximum effect.
Measured: 12 weeks
Effect of Trental Treatment Using the European Evaluation of Vertigo Scale
The European Evaluation of Vertigo scale (EEV) is a physician-administered questionnaire that only assesses symptoms of the vestibular syndrome: illusion of movement, duration of illusion, motion intolerance, neurovegetative signs, and instability. The symptoms are ranked on a scale of 0 (no problem) to 4 (severe problem) and each area of assessment is stand alone (meaning the scores from each area to do not combine to create one larger score)
Measured: 12 Weeks
Effect of Trental Treatment Using the Vestibular Activities and Participation Survey
Vestibular Activities and Participation (VAP) is 34-item self-report tool that measures the extent of activity limitations and participation restrictions caused by vestibular disorders. The VAP can be used for assessment, intervention planning, outcome evaluation, and to reflect a patient's status. Answers are ranked on a likert scale where 0 is no problem and 4 is unable to do. Scores are averaged and the higher the score the worse the problem, such that 0 is no problem and 54 or great is a severe problem.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startJan 2015
- Primary completion31 Dec 2020
- Study completion12 Apr 2021
Why it stopped: Placebo effect
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DizzinessStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnaldo L. Rivera, University of Missouri-Columbia
- Investigators
- Arnaldo E Rivera, M.D., Principal investigator, University of Missouri - Department of Otolaryngology - Head and Neck Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592863
- Sponsor's protocol ID
- 1214160
- Status last verified
- Oct 2024
- First submitted
- 27 Oct 2015
- Last updated
- 15 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomized Trial of Pentoxifylline for Imbalance Secondary to Insufficient Microvascular Perfusion
- ClinicalTrials.gov ID
- NCT02592863
- Acronym / sponsor ID
- 1214160
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Placebo effect
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 30 Oct 2015 (estimated)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Imbalance, dizziness and vertigo as a result of problems in the inner ear (vestibular dysfunction) are becoming increasingly more prevalent in Americans 40 years of age and older. The symptoms have a severe impact on affected individuals with detrimental effects on work, travel, social and family life. These patients see doctors often with no relief in their symptoms.
The most promising help for these patients is to use medication that will increase blood flow to the inner ear. Pentoxifylline (Trental) has been shown to increase microvascular blood flow.
Detailed description
One potential cause of vestibular dysfunction is a decrease in or insufficient blood flow to the inner ear. Studies have shown that when the blood flow is decreased to the inner ear, patients will become dizzy and off balance. This study will use validated instruments to evaluate the effectiveness of Trental in patients that present to our providers with vertigo, dizziness, or imbalance and meet inclusion criteria. They will be blinded and randomized to treatment or placebo, which they will take for ~12 weeks. Patients will completed validated surveys 3 times (beginning, middle and end of study) as well as account for the number of times they have fallen and if they have missed any work due to their symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pentoxifylline | Experimental | Drug: PentoxifyllinePatients will take Trental (Pentoxifylline) 3 times per day for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPatients will take placebo 3 times per day for 12 weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults 40 years and older
- English as primary language
- Diagnosis of multisensory losses, presbystasis, bilateral vestibulopathy, central vascular insufficiency, small vessel circulatory disease, generalized imbalance, and idiopathic peripheral vertigo scoring at least 16 on the Dizziness Handicap Inventory
- Willingness to complete surveys and take medication as prescribed
Key exclusion criteria (8 listed)
- Diagnosis of the following: benign paroxysmal positional vertigo, Meniere's disease, vestibular migraine with headache, intracranial mass, perilymphatic fistula, or multiple sclerosis
- history of cholesteatoma
- Prior ear surgery other than myringotomy and tube placement
- Prior radiation to head or neck
- previous use of vestibulotoxic medications where the enrolling provider determines the drug exposure to be the cause of imbalance
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 |
|---|---|---|
| PentoxifyllineAlso: TrentalPatients will take Trental (Pentoxifylline) 3 times per day for 12 weeks | Drug | Pentoxifylline |
| PlaceboPatients will take placebo 3 times per day for 12 weeks | Drug | Placebo |
Primary outcome
Effect of Trental Treatment Using the Dizziness Handicap Inventory, Vestibular Activities and Participation, and European Evaluation of Vertigo Scale
Time frame: 12 weeks
The Dizziness Handicap Inventory (DHI) is 25 question self report questionnaire that measures how dizziness affects a person's daily life. The questions are grouped into three domains: physical (P), emotional (E), and functional (F). Each question has three possible answers: "Always", "Sometimes", or "No". The answers are worth points, with "Always" being worth 4 points, "Sometimes" worth 2 points, and "No" worth 0 points. After answering all the questions, the total score is calculated, ranging from 0 to 100 points. A higher score indicates a more severe handicap, with 0 points indicating no effect and 100 points indicating maximum effect.
Effect of Trental Treatment Using the European Evaluation of Vertigo Scale
Time frame: 12 Weeks
The European Evaluation of Vertigo scale (EEV) is a physician-administered questionnaire that only assesses symptoms of the vestibular syndrome: illusion of movement, duration of illusion, motion intolerance, neurovegetative signs, and instability. The symptoms are ranked on a scale of 0 (no problem) to 4 (severe problem) and each area of assessment is stand alone (meaning the scores from each area to do not combine to create one larger score)
Effect of Trental Treatment Using the Vestibular Activities and Participation Survey
Time frame: 12 Weeks
Vestibular Activities and Participation (VAP) is 34-item self-report tool that measures the extent of activity limitations and participation restrictions caused by vestibular disorders. The VAP can be used for assessment, intervention planning, outcome evaluation, and to reflect a patient's status. Answers are ranked on a likert scale where 0 is no problem and 4 is unable to do. Scores are averaged and the higher the score the worse the problem, such that 0 is no problem and 54 or great is a severe problem.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Arnaldo E Rivera, M.D. principal investigator
University of Missouri - Department of Otolaryngology - Head and Neck Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pentoxifylline in people with Dizziness and Vertigo, run by University of Missouri-Columbia at 1 site in United States.
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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 15 Oct 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Effect of Trental Treatment Using the Dizziness Handicap Inventory, Vestibular Activities and Participation, and European Evaluation of Vertigo Scale (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2024.