Trental for the Treatment of Vertigo/Dizziness/Imbalance

University of Missouri (MU)

Status: Terminated

Conditions: Vertigo; Dizziness

Treatments: Drug: Pentoxifylline; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02592863

1214160

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 40+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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26 participants in 2 patient groups, including a placebo group

Pentoxifylline

Experimental group

Description:

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

Treatment:

Drug: Pentoxifylline

Placebo

Placebo Comparator group

Description:

Patients will take placebo 3 times per day for 12 weeks

Treatment:

Drug: Placebo