CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 375 enrolled
Drug / intervention
LY2196044 +1 moredrug
Likely dose
LY2196044 250 mg orally once daily (titrated via 50 mg for 1 week then 125 mg for 1 week) for 16 weeksAI-extracted
Key inclusion· 3
  • ✓Diagnosed with Alcohol Dependence meeting ≥3 criteria: tolerance (increased amounts needed or diminished effect), drinking in larger amounts/longer than intended, and persistent desire or unsuccessful efforts to reduce/control use
  • ✓Heavy drinking pattern: >14 drinks/week (women) or >21 drinks/week (men) with ≥2 heavy drinking days/week during consecutive 30 days before screening through randomization
  • ✓Willing to pursue abstinence or reduction in drinking
Key exclusion· 13
  • ✕Acute alcohol withdrawal within past 6 months or currently at significant risk
  • ✕History of serious head injury, intracranial neoplasm/hemorrhage, prior seizure (except remote childhood febrile seizure), or other seizure risk condition
  • ✕Ever taken anticonvulsants for seizure control
  • ✕Substance dependence or abuse (other than alcohol, cannabis, nicotine, caffeine) within 6 months prior to screening

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

Search/NCT00804570
NCT00804570Phase 2Completed
CompareCT.gov

A Phase 2 Study of LY2196044 Compared With Placebo in the Treatment of Alcohol Dependence

Eli Lilly and Company·interventional·Posted Dec 9, 2008·Updated Sep 24, 2019

In Brief

A Phase 2 clinical trial evaluating LY2196044 and placebo for Alcohol Dependence. Completed, enrolled 375 participants across 17 sites.

Detailed Summary

The Primary objective of this study is to test whether LY2196044 can reduce the number of heavy drinking days per month in people with alcohol dependence. Each subject will undergo a screening and assessment period (including medication washout) prior to randomization into a 16 week double blind treatment period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Dependence
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 9, 2008
Enrollment StartNov 1, 2008
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.6 years ago

Interventions

LY2196044drug

250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks

placebodrug

once daily, orally, 16 weeks