Phase 4
N=159
Safety and Efficacy of SPD489 on Executive Function Behaviors in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
ADHD Specifically With Executive Function Impairment
Bottom Line
View on ClinicalTrials.gov: NCT01101022 ↗Enrolled (actual)
159
Serious AEs
0.0%
Results posted
Feb 2012
Primary outcome: Primary: Change From Baseline in Subject-reported Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at up to 10 Weeks — -22.3; -11.1 T-scores — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- SPD489 (Drug); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Subject-reported Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at up to 10 Weeks |
-22.3; -11.1 | <0.0001 sig |
| SECONDARY Change From Baseline in Adult ADHD Impact Module (AIM-A) Multi-Item Scales Total Score at up to 10 Weeks |
38.8; 17.2; 30.6; 15.7; 29.3; 15.8 | <0.0001 sig |
| SECONDARY Change From Baseline in Informant-reported BRIEF-A T-scores at up to 10 Weeks |
-10.2; -5.3; -8.6; -5.5; -10.3; -4.6 | 0.0016 sig |
| SECONDARY Change From Baseline in Subject-reported BRIEF-A T-scores at up to 10 Weeks |
-17.5; -9.2; -22.8; -11.2 | 0.0002 sig |
| SECONDARY Change From Baseline in Subject-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks |
-17.8; -9.5; -14.5; -7.8; -10.9; -5.7 | 0.0001 sig |
| SECONDARY Change From Baseline in Informant-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks |
-10.2; -5.8; -9.1; -4.3; -5.9; -4.6 | 0.0048 sig |
| SECONDARY Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 10 Weeks |
-21.4; -10.3 | <0.0001 sig |
| SECONDARY Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at up to 10 Weeks |
13.9; 6.7; 38.0; 16.0; 21.5; 10.7 | — |
| SECONDARY Percent of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at up to 10 Weeks |
78.5; 34.7 | <0.0001 sig |
| SECONDARY Change From Baseline in AIM-A Multi-Item Scales of Living With ADHD and General Well-being Score at up to 10 Weeks |
14.0; 4.9; 19.7; 9.0 | <0.0001 sig |
| SECONDARY Change From Baseline in AIM-A Quality of Life Questions 1 and 4 Scores at up to 10 Weeks |
1.6; 1.0; -1.0; -0.4 | 0.0184 sig |
| SECONDARY Change From Baseline in Conner's Adult ADHD Rating Scale-Observer: Short Version (CAARS-O:S) ADHD Index T-score at up to 10 Weeks |
-11.3; -5.8 | 0.0019 sig |
| SECONDARY Change From Baseline in CAARS-O:S Factor-derived Subscale T-scores at up to 10 Weeks |
-10.0; -4.9; -9.1; -5.0; -8.0; -4.0 | 0.0017 sig |
| SECONDARY Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Total Score at up to 10 Weeks |
38.0; 17.0; 19.3; 7.2; 18.5; 6.0 | 0.0016 sig |
Summary
The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo on executive function (self-regulation) behaviors in adults with ADHD who report clinically significant impairment of executive function behavior in their everyday environment, as measured by the self-report Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Global Executive Composite (GEC) T-score.
Eligibility Criteria
Inclusion Criteria
- Subject must be 18-55 years of age, inclusive at the time of consent.
- Subject has an established close relationship of at least 6-months duration before screening (Visit -1) with an informant who will be able to observe and be willing to report on the subject's behavior and symptoms in multiple social settings during the course of the study. Informant is defined as a person who has a domicile relationship with the subject. When applicable, the informant should be the subject's spouse/significant other. Additionally, the informant cannot participate as a subject in the study and can only serve as the informant for a single subject.
- Subject has a lifestyle that in the opinion of the Investigator will enable the subject to complete all study testing and requirements defined in the protocol.
- Female subjects must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test at screening (Visit -1) and a negative urine pregnancy test at baseline (Visit 0) and agree to comply with any applicable contraceptive requirements of the protocol.
- Subject meets the 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 total score of ≥65 on BRIEF-A GEC T-score by self-report at baseline (Visit 0).
- Subject has a total score of ≥28 using the Adult ADHD-RS with prompts at baseline (Visit 0).
- Subject must have a minimum level of intellectual functioning as determined by the Investigator at screening (Visit -1).
- Subject is able to swallow a capsule.
- Subject is willing and able to comply with all the testing and requirements defined in this protocol.
- Subject and informant must be able to provide written, personally signed and dated informed consent to participate in the study in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines and applicable regulations before completing any study related procedures.
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. Prohibited disorders include those associated with diagnoses including but not limited to any severe comorbid Axis II disorder or severe Axis I disorder (such as Post Traumatic Stress Disorder [PTSD], psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder). Other symptomatic manifestations (such as agitated states) that contraindicate treatment with SPD489 or confound efficacy or safety assessments in the opinion of the examining physician are also prohibited. 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.
- The subject has a body mass index (BMI) of 139mmHg or diastolic blood pressure >89mmHg. Subjects with well-controlled mild or moderate hypertension on a single antihypertensive agent are allowed. Combination antihypertensive medications are not allowed.
- Subject is taking any medication that is excluded.
- Subject has a documented allergy, hypersensitivity, or intolerance to amphetamines.
- Subject has a documented allergy, hypersensitivity, or intolerance to any excipients in the investigational medicinal product.
- Subject has failed to respond to one or more adequa
Data sourced from ClinicalTrials.gov (NCT01101022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.