Phase 2
Completed N=295
A Study of TD-9855 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Source: ClinicalTrials.gov NCT01458340 ↗Enrolled (actual)
295
Serious AEs
0.3%
Results posted
Mar 2022
Primary outcomePrimary: Change From Baseline in AISRS Total Score at Day 42 — -12.1; -11.7; -12.2 score on a scale — p=0.6026
Summary
The safety and efficacy of multiple dosages of TD-9855, administered once daily, will be evaluated in adult males with ADHD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in AISRS Total Score at Day 42 |
-12.1; -11.7; -12.2 | 0.6026 |
| SECONDARY Change From Baseline in BDEFS-SF: Self Report Total Score at Day 42 |
-9.8; -9.7; -11.6 | 0.5269 |
| SECONDARY Change From Baseline in AISRS Inattentive Subscale at Day 42 |
-6.2; -6.8; -7.2 | — |
| SECONDARY Change From Baseline in AISRS Hyperactive-impulsive Subscale at Day 42 |
-5.2; -5.1; -5.0 | — |
| SECONDARY Percentage of Participants With an AISRS Response at Day 42 |
46.1; 43.9; 51.9 | — |
| SECONDARY Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Day 42 |
-1.0; -0.8; -1.0 | — |
| SECONDARY Change From Baseline in Adult ADHD Self-Report Scale (ASRS) Total Score at Day 42 |
-12.5; -12.1; -14.0 | — |
| SECONDARY Change From Baseline in ASRS Inattentive Subscale at Day 42 |
-6.7; -6.9; -7.7 | — |
| SECONDARY Change From Baseline in ASRS Hyperactive-impulsive Subscale at Day 42 |
-5.9; -5.2; -6.3 | — |
| SECONDARY Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 42 |
-1.3; -0.3; -0.9 | — |
| SECONDARY Percentage of Participants With a Reliable Change on the BDEFS-SF at Day 42 |
30.4; 32.6; 47.6 | — |
| SECONDARY Percentage of Participants With a Reliable Change and Normalized Score on the BDEFS-SF at Day 42 |
29.0; 28.8; 38.2 | — |
| SECONDARY Change From Baseline in BDEFS-SF Symptom Count at Day 42 |
-3.3; -4.2; -4.5 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects must meet the following ADHD diagnostic and inclusion criteria:
- Subjects must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for current ADHD subtypes (ADHD combined type, ADHD predominately inattentive type, ADHD predominately hyperactive-impulsive type) as assessed by the clinical interview and confirmed by Adult Attention-Deficit/Hyperactivity Disorder Clinical Diagnostic Scale (ACDS V1.2).
- Subjects must have a total score of 24 or greater on the AISRS at both the Screening and Baseline Visits AND the Baseline Visit AISRS scores must not vary by more than 20% from Screening.
- Subjects are required to have CGI-S score ≥4 (moderate) at both the Screening and Baseline Visits. Subjects should have at least moderate severity for ADHD symptoms.
- For women of childbearing potential, documentation of a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 0. All female subjects of childbearing potential must be using a highly effective method of birth control during the study and for at least 1 month after completion of study drug dosing.
- A highly effective method of birth control is defined as one that results in a low failure rate (i.e., 15.
- A diagnosis of ADHD NOS.
- Any diagnosis of lifetime bipolar disorder or psychotic disorder
- A current diagnosis of any severe comorbid Axis II disorder
- Any history of mental retardation, organic mental disorders due to general medical condition or pervasive developmental disorder as defined by DSM-IV-TR.-
Data sourced from ClinicalTrials.gov (NCT01458340). 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.