Trental for the Treatment of Vertigo/Dizziness/Imbalance

Dizziness Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled, Randomized Trial of Pentoxifylline for Imbalance Secondary to Insufficient Microvascular Perfusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02592863
• Other study ID #: 1214160
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: April 12, 2021

Study information

• Verified date: April 2021
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 12, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dizziness
• Vertigo

Intervention

Drug:
• Pentoxifylline
Patients will take Trental (Pentoxifylline) 3 times per day for 12 weeks
• Placebo
Patients will take placebo 3 times per day for 12 weeks

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2-3 years