drugset / Trial / NCT00683462

An Exploratory Trial of AZD3480 (TC-1734) for the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD)

NCT00683462 ↗

Phase 2 Completed 24 enrolled AstraZeneca Targacept Inc. · collab
RandomizedCrossoverQuadruple-blindTreatment

Summary

A 3-way cross-over trial of two weeks of treatment with three drug conditions. AZD3480 will be given in doses of (A) 5mg/day, (B) 50 mg/day and (C) placebo to 24 non-smoking adults with DSM-IV confirmed ADHD. Three week washout between each treatment period. CYP2D6 genotyping will be completed at screening and slow metabolisers will be excluded from participation in this study. Cognitive, ADHD symptom, safety and pharmacokinetic (PK) assessments will be made during each treatment period. Safety and tolerability assessments will be a major component of the trial and all serious adverse events (SAE) will be immediately (within 24 hours) reported to both Targacept and to AstraZenca.

Timeline

Start
2008-05
Primary completion
—
Completion
2009-07

Outcome

Met primary endpoint

paper SST performance and total ADHD symptoms were significantly improved with 50 mg of AZD3480. PMID 23856296 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject ispronicline Small molecule 5 mg —
Subject ispronicline Small molecule 50 mg —