Gabapentin for the Treatment of Tinnitus

Phase 2/3 Terminated 160 enrolled Washington University School of Medicine National Institute on Deafness and Other Communication Disorders (NIDCD) · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The specific aim of the Gabapentin for the Relief of Idiopathic Subjective Tinnitus Trial is to assess the therapeutic benefit of Gabapentin (Neurontin®) for subjective idiopathic troublesome tinnitus. We employed a double-blind placebo-controlled randomized clinical trial design to assess the efficacy of Gabapentin. Adults, between the ages of 18 and 70 with idiopathic, subjective, troublesome, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or greater and score of 38 or greater on the Tinnitus Handicap Inventory were enrolled.

Timeline

Start: 2004-04
Primary completion: —
Completion: 2006-02

Outcome

Missed primary endpoint

paper The difference was 0.03 (95% confidence interval, -5.5 to 6.2; P = .91). PMID 17438255 ↗

paper Gabapentin is no more effective than placebo for the relief of idiopathic subjective tinnitus. PMID 17438255 ↗

Publications

Piccirillo JF, Finnell J, Vlahiotis A, Chole RA, Spitznagel E Jr. Relief of idiopathic subjective tinnitus: is gabapentin effective? Arch Otolaryngol Head Neck Surg. 2007 Apr;133(4):390-7. doi: 10.1001/archotol.133.4.390.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gabapentin	Unknown	900 mg	—
Subject	Gabapentin	Unknown	3600 mg	—