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Trial record 1 of 1 for:    NCT00697515
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Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

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ClinicalTrials.gov Identifier: NCT00697515
Recruitment Status : Completed
First Posted : June 16, 2008
Results First Posted : February 1, 2010
Last Update Posted : December 12, 2011
Sponsor:
Information provided by (Responsible Party):
Shire

Tracking Information
First Submitted Date  ICMJE June 11, 2008
First Posted Date  ICMJE June 16, 2008
Results First Submitted Date  ICMJE November 20, 2009
Results First Posted Date  ICMJE February 1, 2010
Last Update Posted Date December 12, 2011
Study Start Date  ICMJE July 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2010)
Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase [ Time Frame: 2, 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 13, 2008)
PERMP Rating Scale [ Time Frame: The PERMP will be administered at visit 5 and 6 ]
Change History Complete list of historical versions of study NCT00697515 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2010)
  • PERMP Total Score by Timepoint in the Crossover Phase [ Time Frame: 2, 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.
  • PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase [ Time Frame: 2, 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.
  • PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase [ Time Frame: 2, 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.
  • Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale With Prompts (ADHD-RS) Total Score at up to 28 Days in the Dose Optimization Phase [ Time Frame: Baseline 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.
  • ADHD-RS With Prompts Total Score in the Crossover Phase [ Time Frame: 7 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.
  • Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase [ Time Frame: Baseline ]
    CGI-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)
  • Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Dose Optimization Phase [ Time Frame: 7, 14, 21 and 28 days ]
    CGI-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.
  • Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Crossover Phase [ Time Frame: 7 days ]
    CGI-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.
  • Change From Baseline in the Brown Attention Deficit Disorder Scale (BADDS) Total Scores at 26 Days in the Dose Optimization Phase [ Time Frame: Baseline and 26 days ]
    The 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.
  • Level of Satisfaction With Study Treatment on Medication Satisfaction Questionnaire (MSQ) in the Dose Optimization Phase [ Time Frame: 26 days ]
    MSQ is a survey rating the subject's level of satisfaction with the study treatment medication.
  • Change From Baseline in Adult ADHD Impact Module (AIM-A) Question 1 Score at 26 Days in the Dose Optimization Phase [ Time Frame: Baseline and 26 days ]
    AIM-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).
  • Change From Baseline in AIM-A Question 4 Score at 26 Days in the Dose Optimization Phase [ Time Frame: Baseline 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).
  • Change From Baseline in Systolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase [ Time Frame: Baseline and 7, 14, 21 and 28 days ]
  • Change From Baseline in Diastolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase [ Time Frame: Baseline and 7, 14, 21 and 28 days ]
  • Change From Baseline in Pulse Rate at Up to 28 Days in the Dose Optimization Phase [ Time Frame: Baseline and 7, 14, 21 and 28 days ]
  • Change From Baseline in Electrocardiogram Results (QTcF Interval) at 7 Days in the Crossover Phase [ Time Frame: Baseline 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2008)
ADHD-RS, CGI, Safety, AIM-A, BADDS, MSQ [ Time Frame: The ADHD-RS, CGI, and PERMP will be administered at every visit starting at baseline. The AIM-A and BADDS will be administered at baseline and Day 26. The MSQ is given at Day 26. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
Official Title  ICMJE A Phase IIIb Randomized, Double-Blind, Multicenter, Placebo-Controlled, Dose Optimization, Crossover, Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
Brief Summary To evaluate the efficacy of LDX compared to placebo in adults with ADHD in the adult workplace environment (AWE) setting
Detailed Description This study has both an optimization and double-blind period
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE ADHD
Intervention  ICMJE
  • Drug: LDX
    oral, 30, 50, or 70 mg once-daily for 4 weeks during dose optimization, and then for 1 week during each crossover during the adult workplace environment setting
  • Drug: Placebo
    Placebo administered once-daily for one week during the adult workplace environment setting
Study Arms  ICMJE
  • Active Comparator: Lisdexamfetamine Dimesylate (LDX, SPD489)
    Intervention: Drug: LDX
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 1, 2009)
142
Original Estimated Enrollment  ICMJE
 (submitted: June 13, 2008)
106
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject must be 18-55 years of age, inclusive at the time of consent.
  • Female subjects must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to comply with any applicable contraceptive requirements of the protocol.
  • Subject meets Diagnostic and Statistical Manual of Mental Disorders Fourth Edition; Text Revision (DSM IV TR) criteria for a primary diagnosis of ADHD (diagnostic code 314.00 and 314.01) established by a comprehensive psychiatric evaluation that reviews DSM-IV-TR criteria with at least 6 of the 9 subtype criteria met. The Adult ADHD Clinical Diagnostic Scale version 1.2 (ACDS v1.2) will be utilized as the diagnostic tool.
  • Subject has a Baseline score of > or equal to 28 using the Adult ADHD-RS with prompts.
  • Subject must have a minimum level of intellectual functioning, as determined by an Intelligent Quotient (IQ) score of 80 or above based on the Kaufman Brief Intelligence Test (KBIT).

Exclusion Criteria:

  • Subject has a current comorbid psychiatric disorder that is either controlled with medications prohibited in this study or is uncontrolled and associated with significant symptoms. Comorbid psychiatric diagnoses will be established by the psychiatric evaluation that includes the Structured Clinical Interview for DSM-IV-TR disorders (SCID-I).
  • Subjects who are currently considered a suicide risk, any subject who has previously made a suicide attempt or those who are currently demonstrating active suicidal ideation.
  • Subject has a history of seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder.
  • Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, transient ischemic attack or stroke or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
  • Subject has current abnormal thyroid function, as defined as abnormal Screening thyroid stimulating hormone. Treatment with a stable dose of thyroid medication for at least 3 months is permitted.
  • Subject has a history of moderate to severe hypertension or has a resting sitting systolic blood pressure >139mmHg or diastolic blood pressure >89mmHg.
  • Subject has a documented allergy, hypersensitivity, or intolerance to amphetamines.
  • Subject has failed to respond to one or more adequate courses (dose and duration) of amphetamine therapy.
  • Subject has glaucoma.
  • Subject is taking other medications that have central nervous system (CNS) effects or affect performance, such as sedating antihistamines and decongestant sympathomimetics, or are monoamine oxidase inhibitors (during or within 14 days of test or reference product administration). Stable use of bronchodilator inhalers is not exclusionary.
  • Subject is female and pregnant or lactating.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00697515
Other Study ID Numbers  ICMJE SPD489-316
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shire
Study Sponsor  ICMJE Shire
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tim Wigal, PhD University of CA, Irvine Child Development Center
PRS Account Shire
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP