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NCT01458340 · ClinicalTrials.gov registry record · Phase 2
A Study of TD-9855 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
A Phase 2 study of Attention Deficit Hyperactivity Disorder and ADHD, sponsored by Theravance Biopharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 295
- Enrollment target
- 17
- Study locations
NCT01458340: Completed Phase 2 study of Attention Deficit Hyperactivity Disorder and ADHD, sponsored by Theravance Biopharma.
NCT01458340 is a Phase 2 study of Attention Deficit Hyperactivity Disorder and ADHD that has completed, run by Theravance Biopharma. The registered enrollment target is 295 participants, above the 214-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (38% higher). The trial reports 17 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01458340, a Phase 2 study of Attention Deficit Hyperactivity Disorder and ADHD, has completed, sponsored by Theravance Biopharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 295 participants
- Enrollment target
- 17
- Study locations
Study Summary
The safety and efficacy of multiple dosages of TD-9855, administered once daily, will be evaluated in adult males with ADHD.
Primary Outcome
The AISRS is a modified version of the ADHD Rating Scale that more accurately reflects the impact and severity of ADHD among adults. It is a clinician-administered scale that measures all 18 symptoms of adult ADHD using a Likert scale from 0 (not present) to 3 (severe). The total score ranges from 0 to 54 with a negative change from baseline indicating an improvement in severity/reduction in symptoms.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TD-9855
Study Locations (17)
Florida
- Florida Clinical Research Center, LLC - Bradenton
- Clinical Neuroscience Solutions, Inc. - Jacksonville
- Florida Clinical Research Center - Maitland
- Janus Ctr. for Psychiatric Research - Palm Beach
Utah
- Psychiatric & Behavioral Solutions - Salt Lake City
- Lifetree Clinical Research, LC - Salt Lake City
Georgia
- Carman Research - Smyrna
Kansas
- Psychiatric Associates - Overland Park
Missouri
- Midwest Research Group - Saint Charles
Nevada
- Ctr. for Psychiatry & Behavioral Med. - Las Vegas
New York
- Adult ADHD Program - New York
Oklahoma
- IPS Research - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 295 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-11 |
| Phase | Phase 2 |
What the finished NCT01458340 record still lists
NCT01458340 is an interventional study that assigns participants to a tested intervention. The registered 295 participants enrollment target is mid-sized for trials with a published cap, above the 214-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (38% higher).
The record links to 2 conditions, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01458340 lists 17 locations in 13 states (Florida, Utah, Georgia).
Frequently Asked Questions
What is clinical trial NCT01458340 about?
NCT01458340 is a clinical study titled "A Study of TD-9855 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)". The safety and efficacy of multiple dosages of TD-9855, administered once daily, will be evaluated in adult males with ADHD.
What is the current status of trial NCT01458340?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 295 participants. The study started on 2011-12. Estimated completion is 2013-11.
What conditions does trial NCT01458340 study?
This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder, ADHD.
What interventions are being tested in trial NCT01458340?
The interventions under investigation include: Placebo (DRUG), TD-9855 (DRUG).
Who is sponsoring clinical trial NCT01458340?
This trial is sponsored by Theravance Biopharma, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01458340 being conducted?
This trial has 17 study locations across Florida, Georgia, Kansas, Missouri, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01458340's enrollment target sits among peer trials
295 20th of 102 higher than 83 of 102 other Attention Deficit Hyperactivity Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder 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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