CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 156 enrolled
Drug / intervention
Zonisamide +1 moredrug
Likely dose
Zonisamide titrated to 500 mg orally dailyAI-extracted
Key inclusion· 5
  • ✓Age 21–70 years
  • ✓DSM-IV-TR alcohol dependence with recognition of need to reduce or stop drinking
  • ✓Regular heavy drinking: ≥2 heavy drinking days per week averaged over 90 days baseline (≥5 drinks/day for men, ≥4 drinks/day for women)
  • ✓Women of childbearing potential must be non-lactating, practicing reliable birth control, and have negative serum pregnancy test
Key exclusion· 10
  • ✕History of hypersensitivity to zonisamide or sulfonamide, Stevens-Johnson Syndrome, penicillin allergy, or severe drug allergic reaction
  • ✕Significant renal disease: serum creatinine above laboratory limit of normal, history of renal failure, chronic renal disease, or conditions expected to result in renal failure
  • ✕History of seizure disorder
  • ✕Current blood dyscrasia (except past iron deficiency anemia)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02900352
NCT02900352Phase 3Completed
CompareCT.gov

Zonisamide Treatment of Alcohol Use Disorder: an Evaluation of Efficacy and Mechanism of Action

Virginia Commonwealth University·interventional·Posted Sep 14, 2016·Updated Oct 13, 2022

In Brief

A Phase 3 clinical trial evaluating Zonisamide and Placebo for Alcohol Use Disorder. Completed, enrolled 156 participants across 4 sites.

Detailed Summary

This is a randomized, placebo-controlled, double-blind, 16 week trial of the medication zonisamide for the treatment of heavy drinking alcoholic civilians.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Use Disorder
CountriesUnited States
CollaboratorsUniversity of Connecticut, Yale University, National Institute on Alcohol Abuse and Alcoholism (NIAAA), VA Connecticut Healthcare System

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 14, 2016
Enrollment StartOct 1, 2016
Primary CompletionApr 22, 2021
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 9.8 years ago

Interventions

Zonisamidedrug

Titration of dose to 500mg oral, daily, over 8 weeks, then 7 weeks of treatment at that dose

Placebodrug

Placebo