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NCT02253745 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, PK & Efficacy of V81444 in Volunteers With Attention Deficit/ Hyperactivity Disorder (ADHD)
A Phase 1 study of ADHD, sponsored by Vernalis (R&D).
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT02253745: Completed Phase 1 study of ADHD, sponsored by Vernalis (R&D).
NCT02253745 is a Phase 1 study of ADHD that has completed, run by Vernalis (R&D). The registered enrollment target is 31 participants, below the 190-participant average among 75 other ADHD trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02253745, a Phase 1 study of ADHD, has completed, sponsored by Vernalis (R&D).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is to evaluate the safety, tolerability, effectiveness, and pharmacokinetics (PK) of twice daily oral doses of V81444 in adults with ADHD. Pharmacokinetics (PK) is the study of how a drug is absorbed, distributed, metabolized, and eventually eliminated by the body. Pharmacokinetics is what the body does to the drug. Blood samples will be taken throughout the study for PK analysis.
Primary Outcome
The absolute and change from baseline in ADHD-RS scores, and percentage change from baseline in ADHD-RS score will be summarized appropriately
Conditions Studied
Interventions
- DRUG Placebo
- DRUG V81444
Study Locations (1)
Kansas
- Vince and Associates Clinical Research - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2013-07 |
| Est. Completion | 2014-04 |
| Phase | Phase 1 |
What the finished NCT02253745 record still lists
NCT02253745 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 190-participant average among 75 other ADHD trials with a reported enrollment target (84% lower).
The record links to 1 condition, with ADHD appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02253745 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT02253745 about?
NCT02253745 is a clinical study titled "Safety, Tolerability, PK & Efficacy of V81444 in Volunteers With Attention Deficit/ Hyperactivity Disorder (ADHD)". The purpose of this research study is to evaluate the safety, tolerability, effectiveness, and pharmacokinetics (PK) of twice daily oral doses of V81444 in adults with ADHD. Pharmacokinetics (PK) is the study of how a drug is absorbed, distributed, metabolized, and eventually eliminated by the body....
What is the current status of trial NCT02253745?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2013-07. Estimated completion is 2014-04.
What conditions does trial NCT02253745 study?
This clinical trial studies the following conditions: ADHD.
What interventions are being tested in trial NCT02253745?
The interventions under investigation include: Placebo (DRUG), V81444 (DRUG).
Who is sponsoring clinical trial NCT02253745?
This trial is sponsored by Vernalis (R&D), which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02253745 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for ADHD
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02253745's enrollment target sits among peer trials
31 61st of 75 higher than 15 of 75 other ADHD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other ADHD trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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