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DEXINA Phase III Study of Dexamfetamine Sulfate Formulations in Adults with ADHD
2022-502903-31-00Phase 3Authorised
- Sponsor
- Medice
- Start
- Mar 2024
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 3, randomised, double-blind trial in attention deficit hyperactivity disorder (ADHD) comparing Attentin immediate-release tablets arm, Modified-release dexamfetamine capsule arm and Placebo arm (3 arms). Primary endpoints: Change in ADHS-DC-Q total score at end of Optimal Stable Dose Phase (Visit 5) vs baseline (Visit 0) for Attentin vs placebo, Change in SDS total score at end of Optimal Stable Dose Phase (Visit 5) vs baseline (Visit 0) for Attentin vs placebo and 4 more. Planned start Mar 2024; status: authorised.
02
Drugs
atomoxetinedextroamphetamine
03
Conditions
attention deficit hyperactivity disorder (ADHD)
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