drugset / Trial / NCT00975481

A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users

NCT00975481 ↗

Phase 1 Completed 36 enrolled Pfizer Medivation, Inc. · collab
RandomizedCrossoverDouble-blind

Summary

Dimebon will not exhibit abuse potential when compared to placebo or a positive control (alprazolam).

Timeline

Start
2009-10
Primary completion
2010-02
Completion
2010-02

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Placebo vs Dimebon 20 mg; p = 0.8428; Mean Difference (Final Values) -0.5792 (95% CI -6.3385 to 5.1800); Mixed Models Analysis NCT00975481 ↗

registry analysis (superiority or other test); Placebo vs Dimebon 20 mg; p = 0.6029; Mean Difference (Final Values) -1.6121 (95% CI -7.7209 to 4.4967); Mixed Models Analysis NCT00975481 ↗

registry analysis (superiority or other test); Placebo vs Dimebon 20 mg; p = 0.2239; Mean Difference (Final Values) -6.3979 (95% CI -16.7479 to 3.9521); Mixed Models Analysis NCT00975481 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Alprazolam Small molecule 1 mg Oral
Comparator Alprazolam Small molecule 3 mg Oral
Subject Latrepirdine Small molecule 20 mg Oral
Subject Latrepirdine Small molecule 40 mg Oral
Subject Latrepirdine Small molecule 60 mg Oral