Phase 3
Completed N=284
An Efficacy and Safety Study for JNS001 in Adults With Attention-Deficit Hyperactivity Disorder
Source: ClinicalTrials.gov NCT01323192 ↗Enrolled (actual)
284
Serious AEs
0.7%
Results posted
Sep 2013
Primary outcomePrimary: Change From Baseline to Endpoint in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Total Attention Deficit-Hyperactivity Disorder (ADHD) Symptoms Scores of Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O: SV) — -12.5; -7.9 Scores on a scale — p=<0.0001
Summary
The main purpose of this study is to evaluate the efficacy of JNS001 titrated to daily doses of 18 to 72 mg in adults with attention-deficit hyperactivity disorder (ADHD) relative to placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Endpoint in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Total Attention Deficit-Hyperactivity Disorder (ADHD) Symptoms Scores of Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O: SV) |
-12.5; -7.9 | <0.0001 sig |
| SECONDARY Mean Change From Baseline to Endpoint in the Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O: SV) Total Score Other Than Total Attention Deficit-Hyperactivity Disorder (ADHD) Symptoms Score |
-19.5; -12.5 | 0.0002 sig |
| SECONDARY Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Scores |
-1.0; -1.0 | <0.0001 sig |
| SECONDARY Clinical Global Impression of Change (CGI-C) Scores |
3; 3 | <0.0001 sig |
| SECONDARY Mean Change From Baseline to Endpoint in the Conners' Adult Attention Deficit-Hyperactivity Disorder (ADHD) Rating Scales-Self Report: Screening Version (CAARS-S:SV) Score |
-18.0; -10.9 | 0.0003 sig |
| SECONDARY Mean Change From Baseline to Endpoint in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Total Scores |
2.4; 0.8 | 0.4041 |
Eligibility Criteria
Inclusion Criteria
- Patients who meet the criteria of ADHD (predominantly inattentive type [314.00], predominantly hyperactive-impulsive type [314.01], and combined type [314.01]) of DSM-IV-TR both at present and in childhood, based on Conners' Adult ADHD Diagnostic Interview for DSM-IV (CAADID) at screening
- DSM-IV Total ADHD Symptoms scores (18 items) of CAARS-O: SV score of = 24 as determined by investigator or co-investigator at baseline
- Healthy on the basis of physical examination, medical history, vital signs, 12-lead ECG and clinical laboratory tests performed at screening
- Women of childbearing potential must have a negative urine pregnancy test at screening
- Patients (and their legally-acceptable representative if patients are 18 or 19 years of age) must have signed an informed consent form (ICF), indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion Criteria
- Presence or history of co-morbid psychiatric diagnosis per DSM-IV-TR criteria of bipolar I disorder, schizophrenia, schizoaffective disorder, or severe obsessive compulsive disorders
- Presence of co-morbid psychiatric diagnosis per DSM-IV-TR criteria of pervasive developmental disorder (including autistic disorder or Asperger's disorder), suicidality, or any other diagnosis that in the judgment the investigator or co-investigator would exclude the patient from the study
- Presence of motor tics, history of Tourette's disorder, or family history of Tourette's disorder
- Known or suspected mental retardation
Data sourced from ClinicalTrials.gov (NCT01323192). 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. Informational only — not medical advice.