Evaluation of Immediate-Release Viloxazine in Adults With ADHD
- Conditions
- Attention-Deficit/Hyperactivity Disorder (ADHD)
- Interventions
- Drug: Placebo
- Registration Number
- NCT01107496
- Lead Sponsor
- Supernus Pharmaceuticals, Inc.
- Brief Summary
This will be a randomized, double-blind, placebo-controlled, parallel group, safety and tolerability study in adults with ADHD. The target subjects are healthy male or female adults aged 18 to 64 years, inclusive, with a diagnosis of ADHD.
- Detailed Description
This will be a randomized, double-blind, multicenter, placebo-controlled, parallel group, safety and tolerability study in adults with ADHD. The target subjects are healthy male or female adults aged 18 to 64 years of age, inclusive, with a diagnosis of ADHD. Approximately 50 subjects will be enrolled at approximately 5 sites in the United States. Subjects will be randomized (1:1) to one of two treatment groups, immediate-release (IR) viloxazine or placebo. Primary objective is to determine the safety of IR viloxazine in adults with ADHD.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IR Viloxazine IR Viloxazine Treatment A: immediate-release (IR) viloxazine capsules administered orally 3 times a day Placebo Placebo Treatment B: Placebo capsules administered orally 3 times a day
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events During 6 Weeks of Treatment Weeks 1-6 The percent of subjects who took at least one dose of immediate-release viloxazine (Safety Population; N) and who reported at least one Adverse Event (n). The percent is calculated by dividing "the number of subjects who reported at least one Adverse Event (n)" by "the number of subjects in the Safety Population (N)" and multiplying the product by 100. The higher the percentage, the higher the incidence in the Safety Population
- Secondary Outcome Measures
Name Time Method Change From Baseline in the Investigator-Rated Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (CAARS) Total Score at Week 6 (End of Study) Baseline and Week 6 The Conners' Adult ADHD Rating Scale (CAARS) is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology in adults. The CAARS consists of 30 items, including 18 items that correspond to the 18 ADHD symptoms per the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV). The 18 items are further subdivided into two subscales: Inattention (9 items) and Hyperactivity/Impulsivity (9 items). Each item is rated on a 4-point scale from 0 (not at all, never) to 3 (very much, very frequently). The sum of 18 items yields the raw Total score (range: 0 to 54; the higher the score, the more severe the ADHD symptoms). Raw score is converted to a change from baseline (CFB) score. A lower CFB score (\<0) represents a better outcome.
Change From Baseline in the Investigator-Rated Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (CAARS) Total Score at Week 1 Baseline and Week 1 The Conners' Adult ADHD Rating Scale (CAARS) is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology in adults. The CAARS consists of 30 items, including 18 items that correspond to the 18 ADHD symptoms per the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV). The 18 items are further subdivided into two subscales: Inattention (9 items) and Hyperactivity/Impulsivity (9 items). Each item is rated on a 4-point scale from 0 (not at all, never) to 3 (very much, very frequently). The sum of 18 items yields the raw Total score (range: 0 to 54; the higher the score, the more severe the ADHD symptoms). Raw score is converted to a change from baseline (CFB) score. A lower CFB score (\<0) represents a better outcome.
Change in Global Clinical Impression-Improvement (CGI-I) Score From Baseline Global Clinical Impression-Severity of Illness (CGI-S) Score at Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6 Weeks 1, 2, 3, 4, 5, and 6 The Global Clinical Impression-Improvement (CGI-I) scale is a single item clinician-rated assessment of how much the subject's condition (symptoms) has improved, worsened, or has not changed relative to his/her baseline state prior to the beginning of treatment; it is rated on a 7-point scale from 1 to 7, where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse. The Clinical Global Impression-Severity of Illness (CGI-S) score is a single item clinician-rated assessment of the severity of subject's condition (symptoms) in relation to the clinician's total experience with patients with ADHD; it is rated on a 7-point scale with 1=Normal, not at all ill, 2=Borderline Ill, 3=Mildly Ill, 4=Moderately Ill, 5=Markedly Ill, 6=Severely Ill, 7=Among the most extremely ill patients. CGI-I scores at post-baseline visits were subtracted from CGI-S score at baseline; a change from baseline score \<0 represent better outcome.
Change From Baseline in the Investigator-Rated Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (CAARS) Total Score at Week 2, Week 3, Week 4, and Week 5 Baseline and Weeks 2, 3, 4, and 5 The Conners' Adult ADHD Rating Scale (CAARS) is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology in adults. The CAARS consists of 30 items, including 18 items that correspond to the 18 ADHD symptoms per the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV). The 18 items are further subdivided into two subscales: Inattention (9 items) and Hyperactivity/Impulsivity (9 items). Each item is rated on a 4-point scale from 0 (not at all, never) to 3 (very much, very frequently). The sum of 18 items yields the raw Total score (range: 0 to 54; the higher the score, the more severe the ADHD symptoms). Raw score is converted to a change from baseline (CFB) score. A lower CFB score (\<0) represents a better outcome.
Change From Baseline in the Self-rated Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (CAARS) Total Score at Week 6 Baseline and Week 6 The Conners' Adult ADHD Rating Scale (CAARS) is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology in adults. The CAARS consists of 30 items, including 18 items that correspond to the 18 ADHD symptoms per the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV). The 18 items are further subdivided into two subscales: Inattention (9 items) and Hyperactivity/Impulsivity (9 items). Each item is rated on a 4-point scale from 0 (not at all, never) to 3 (very much, very frequently). The sum of 18 items yields the raw Total score (range: 0 to 54; the higher the score, the more severe the ADHD symptoms). Raw score is converted to a change from baseline (CFB) score. A lower CFB score (\<0) represents a better outcome.
Global Clinical Impression-Improvement (CGI-I) Score at Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6 Weeks 1, 2, 3, 4, 5, and 6 The Global Clinical Impression-Improvement (CGI-I) scale is a single item clinician-rated assessment of how much the subject's condition (symptoms) has improved, worsened, or has not changed relative to his/her baseline state prior to the beginning of treatment; it is rated on a 7-point scale from 1 to 7, where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse. A CGI-I score \<4 represents a better outcome.