Trental for the Treatment of Vertigo/Dizziness/Imbalance



Status:Enrolling by invitation
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:40 - Any
Updated:7/27/2018
Start Date:January 2015
End Date:January 2021

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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.

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.

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.
We found this trial at
1
site
Columbia, Missouri 65211
(573) 882-2121
Principal Investigator: Arnaldo Rivera, M.D.
Phone: 573-882-2549
University of Missouri T he University of Missouri was founded in 1839 in Columbia, Mo.,...
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Columbia, MO
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