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Trental for the Treatment of Vertigo/Dizziness/Imbalance

Primary Purpose

Dizziness, Vertigo

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pentoxifylline
Placebo
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dizziness

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adults 40 years and older
  2. English as primary language
  3. 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
  4. Willingness to complete surveys and take medication as prescribed

Exclusion Criteria:

  1. Diagnosis of the following: benign paroxysmal positional vertigo, Meniere's disease, vestibular migraine with headache, intracranial mass, perilymphatic fistula, or multiple sclerosis
  2. history of cholesteatoma
  3. Prior ear surgery other than myringotomy and tube placement
  4. Prior radiation to head or neck
  5. previous use of vestibulotoxic medications where the enrolling provider determines the drug exposure to be the cause of imbalance
  6. Use of blood thinning medications
  7. intolerance/allergy to pentoxifylline or methylxanthines, as well as recent cerebral or retinal hemorrhage (past 3 months)
  8. Pregnant or lactating females.

Sites / Locations

  • University of Missouri

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pentoxifylline

Placebo

Arm Description

Patients will take Trental (Pentoxifylline) 3 times per day for 12 weeks

Patients will take placebo 3 times per day for 12 weeks

Outcomes

Primary Outcome Measures

Effect of Trental as assessed by Quality of Life questionnaire
Validated questionnaire that will assess the patients quality of life, symptom severity, and functionality as reported by the patient

Secondary Outcome Measures

Full Information

First Posted
October 27, 2015
Last Updated
April 12, 2021
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT02592863
Brief Title
Trental for the Treatment of Vertigo/Dizziness/Imbalance
Official Title
A Double-Blind, Placebo-Controlled, Randomized Trial of Pentoxifylline for Imbalance Secondary to Insufficient Microvascular Perfusion
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
April 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dizziness, Vertigo

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pentoxifylline
Arm Type
Experimental
Arm Description
Patients will take Trental (Pentoxifylline) 3 times per day for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will take placebo 3 times per day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Pentoxifylline
Other Intervention Name(s)
Trental
Intervention Description
Patients will take Trental (Pentoxifylline) 3 times per day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients will take placebo 3 times per day for 12 weeks
Primary Outcome Measure Information:
Title
Effect of Trental as assessed by Quality of Life questionnaire
Description
Validated questionnaire that will assess the patients quality of life, symptom severity, and functionality as reported by the patient
Time Frame
2-3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaldo E Rivera, M.D.
Organizational Affiliation
University of Missouri - Department of Otolaryngology - Head and Neck Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States

12. IPD Sharing Statement

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Trental for the Treatment of Vertigo/Dizziness/Imbalance

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