Trental for the Treatment of Vertigo/Dizziness/Imbalance

NCT ID: NCT02592863

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2021-04-12

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.

Conditions

Dizziness; Vertigo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pentoxifylline

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

Group Type: EXPERIMENTAL

Pentoxifylline

Intervention Type: DRUG

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

Placebo

Patients will take placebo 3 times per day for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patients will take placebo 3 times per day for 12 weeks

Interventions

Pentoxifylline

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

Intervention Type: DRUG

Placebo

Patients will take placebo 3 times per day for 12 weeks

Intervention Type: DRUG

Other Intervention Names

Trental

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Arnaldo L. Rivera

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arnaldo E Rivera, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Missouri - Department of Otolaryngology - Head and Neck Surgery

Locations

University of Missouri

Columbia, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1214160

Identifier Type: -

Identifier Source: org_study_id