Attention Deficit Hyperactivity Disorder
Conditions
Keywords
Attention Deficit Hyperactivity Disorder in adults
Brief summary
This study will be a randomized, double-blind, placebo-controlled crossover study to assess the effects of GTS21 (25 mg three times a day (tid), 75 mg tid, 150 mg tid) compared to placebo in non-smoking adults aged 18-55 with a diagnosis of ADHD, any subtype.
Interventions
DRUGGTS21/Placebo
Sponsors
CoMentis
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Male or female between the ages of 18-55, inclusive. * Diagnostic and Statistical Manual for the Classification of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD, any subtype, based on a detailed psychiatric evaluation including the Conners' Adult ADHD Interview for DSM-IV (CAADID) and the Structured Clinical Interview for DSM-IV (SCID). * A minimum Total ADHD Symptoms Index score of 28 on the clinician administered CAARS. * A Clinical Global Impressions-Severity (CGI-S) score of ≥ 4 at Screening. * Normal or clinically insignificant ECG and clinical laboratory (e.g., liver enzymes, complete blood count, etc.) findings at Screening. * Intellectual function at age-appropriate levels, as deemed by the Investigator. * Supine systolic and diastolic blood pressure measurements \< 140 and \< 90, respectively, at Screening. * Written, signed and dated informed consent for the patient to participate in the study must have been given by the patient. * Females of child-bearing potential must have had a negative serum beta human chorionic gonadotropin (HCG) pregnancy test at Screening and be practicing double-barrier methods of contraception, if sexually active and for 30 days following administration of any study drug. * Male patients who were sexually active must have agreed to use a reliable form of contraception during the study and for 30 days following administration of any study drug. * Be fluent in English (speaking, writing and reading).
Exclusion criteria
* Any current, controlled (requiring a prohibited medication) or uncontrolled, comorbid psychiatric diagnosis (except simple phobias), all major depressive disorders \[dysthymia and mood disorder not otherwise specified (NOS) allowed unless medication required\],and any severe comorbid Axis II disorders or severe Axis I disorders such as Post Traumatic Stress Disorder, bipolar illness, psychosis, obsessive-compulsive disorder, substance abuse disorder, or other symptomatic manifestations that, in the opinion of the Investigator, contraindicated treatment with GTS21 or confound efficacy or safety assessments. * Any condition or illness (including clinically significant abnormal laboratory values) which, in the opinion of the Investigator, represented an inappropriate risk to the patient and/or could confound the interpretation of the study. * Regular use of nicotine products (including 90 days before Screening), including smoking, transdermal patch, chewing tobacco, etc. (verified via salivary cotinine levels at Screening). * Current use of any prohibited medication or other medications, including herbal supplements, that have central nervous system (CNS) effects or affect cognitive performance, such as sedating antihistamines and decongestant sympathomimetics (bronchodilators were permitted). * Use of another investigational product or participation in a clinical study within 30 days prior to Screening. * Body Mass Index (BMI) \> 32. * Known or suspected allergy, hypersensitivity, or clinically significant intolerance to nicotine or nicotinic agonists. * Clinically important abnormality on urine drug screen (excluding the patient's current ADHD stimulant, if applicable) at Screening. * Pregnant or currently lactating. * Patients that had previously been enrolled into this study and subsequently withdrawn.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Assess the Safety and Tolerability of GTS21 (25 mg Tid, 75 mg Tid, 150 mg Tid). | Baseline to study completion | The proportion of subjects with Treatment Emergent Adverse Events. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 25 mg Tid | 8 |
| 75 mg Tid | 16 |
| 150 mg Tid | 8 |
| Total | 32 |
Baseline characteristics
| Characteristic | 75 mg Tid | 150 mg Tid | 25 mg Tid | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 8 Participants | 8 Participants | 32 Participants |
| Age Continuous | 371. years STANDARD_DEVIATION 10.24 | 34.8 years STANDARD_DEVIATION 15.42 | 41.5 years STANDARD_DEVIATION 9.47 | 39.2 years STANDARD_DEVIATION 10.69 |
| Region of Enrollment United States | 16 participants | 8 participants | 8 participants | 32 participants |
| Sex: Female, Male Female | 7 Participants | 3 Participants | 2 Participants | 12 Participants |
| Sex: Female, Male Male | 9 Participants | 5 Participants | 6 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 8 | 13 / 18 | 8 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 16 | 0 / 8 |
Outcome results
Primary
To Assess the Safety and Tolerability of GTS21 (25 mg Tid, 75 mg Tid, 150 mg Tid).
The proportion of subjects with Treatment Emergent Adverse Events.
Time frame: Baseline to study completion
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 25 mg Tid | To Assess the Safety and Tolerability of GTS21 (25 mg Tid, 75 mg Tid, 150 mg Tid). | 67 % of subjects |
| 75 mg Tid | To Assess the Safety and Tolerability of GTS21 (25 mg Tid, 75 mg Tid, 150 mg Tid). | 72 % of subjects |
| 150 mg Tid | To Assess the Safety and Tolerability of GTS21 (25 mg Tid, 75 mg Tid, 150 mg Tid). | 100 % of subjects |