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Central Nervous System Stimulant

Adhansia XR for Attention Deficit Hyperactivity Disorder (ADHD) (RE-DAX Trial)

Phase 4
Waitlist Available
Research Sponsored by Purdue Pharma LP
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, months -1, -2, -3, -4, -5 and -6
Awards & highlights

Summary

The purpose of this study is to investigate the treatment effectiveness of Adhansia XR at month-2 after initiation, and the effectiveness of Adhansia XR overall and when compared with the active comparator group (Concerta) over time.

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, months -1, -2, -3, -4, -5 and -6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, months -1, -2, -3, -4, -5 and -6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR
Secondary study objectives
Adult ADHD Quality of Life Scale - Revised (AAQoL-R)
Assessment of Clinical Global Impression-Improvement (CGI-I)
Assessment of Clinical Global Impression-Severity (CGI-S)
+5 more

Side effects data

From 2020 Phase 4 trial • 267 Patients • NCT02039908
51%
Appetite Loss
40%
Insomnia
33%
Irritability
29%
Picking at skin, nailbiting
21%
Dull, tired, listless
21%
Worried/Anxious
19%
Tearful, depressed
18%
Stomachache
13%
Headache
13%
Motor Tics
12%
Buccal-lingual movements
10%
Social Withdrawal
1%
Hospitalized
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1-Medication First
Phase 1 - Placebo First
Phase 2 - 7-Day Dosing
Phase 2 - 5-Day Dosing

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Adhansia XRExperimental Treatment1 Intervention
Adhansia XR capsules taken orally once daily with or without food.
Group II: ConcertaActive Control1 Intervention
Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.

Find a Location

Who is running the clinical trial?

Purdue Pharma LPLead Sponsor
78 Previous Clinical Trials
15,501 Total Patients Enrolled
6 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,143 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
~53 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
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