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Trial · NCT00697515

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPermanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase2, 4, 8, 10, 12 and 14 hours post-dose on Day 7
The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.
SecondaryPERMP Total Score by Timepoint in the Crossover Phase2, 4, 8, 10, 12 and 14 hours post-dose on Day 7
The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.
SecondaryPERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase2, 4, 8, 10, 12 and 14 hours post-dose on Day 7
The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.
SecondaryPERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase2, 4, 8, 10, 12 and 14 hours post-dose on Day 7
The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.
SecondaryChange From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale With Prompts (ADHD-RS) Total Score at up to 28 Days in the Dose Optimization PhaseBaseline and 7, 14, 21 and 28 days
The Attention Deficit Hyperactivity Disorder Rating Scale with Prompts (ADHD-RS) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
SecondaryADHD-RS With Prompts Total Score in the Crossover Phase7 days
The Attention Deficit Hyperactivity Disorder Rating Scale with Prompts (ADHD-RS) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
SecondaryAssessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization PhaseBaselineCGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
SecondaryNumber of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Dose Optimization Phase7, 14, 21 and 28 daysCGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
SecondaryNumber of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Crossover Phase7 daysCGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
SecondaryChange From Baseline in the Brown Attention Deficit Disorder Scale (BADDS) Total Scores at 26 Days in the Dose Optimization PhaseBaseline and 26 daysThe BADDS assessment consists of 40 items rated on a scale from 0 (never) to 3 (almost daily). The total score ranges from 0 to 120 with increasing scores indicating more severe impairment.
SecondaryLevel of Satisfaction With Study Treatment on Medication Satisfaction Questionnaire (MSQ) in the Dose Optimization Phase26 daysMSQ is a survey rating the subject's level of satisfaction with the study treatment medication.
SecondaryChange From Baseline in Adult ADHD Impact Module (AIM-A) Question 1 Score at 26 Days in the Dose Optimization PhaseBaseline and 26 daysAIM-A is a quality of life instrument. Question 1 is 'On a scale of 1 to 10, how would you rate the overall quality of life right now?' It is rated on a scale of 1 (worst) to 10 (best).
SecondaryChange From Baseline in AIM-A Question 4 Score at 26 Days in the Dose Optimization PhaseBaseline and 26 days
AIM-A is a quality of life instrument. Question 4 is 'How much do you agree with this statement: Over the past few weeks, I've had more good days than bad days?' This is rated on a scale of 1 (strongly agree) to 5 (strongly disagree).
SecondaryChange From Baseline in Systolic Blood Pressure at Up to 28 Days in the Dose Optimization PhaseBaseline and 7, 14, 21 and 28 days
SecondaryChange From Baseline in Diastolic Blood Pressure at Up to 28 Days in the Dose Optimization PhaseBaseline and 7, 14, 21 and 28 days
SecondaryChange From Baseline in Pulse Rate at Up to 28 Days in the Dose Optimization PhaseBaseline and 7, 14, 21 and 28 days
SecondaryChange From Baseline in Electrocardiogram Results (QTcF Interval) at 7 Days in the Crossover PhaseBaseline and 7 days
QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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