Phase 2
Completed N=32
Safety and Efficacy of GTS21 in Adults With Attention-deficit Hyperactivity Disorder
Source: ClinicalTrials.gov NCT00419445 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Sep 2010
Primary outcomePrimary: To Assess the Safety and Tolerability of GTS21 (25 mg Tid, 75 mg Tid, 150 mg Tid). — 67; 72; 100 % of subjects
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Assess the Safety and Tolerability of GTS21 (25 mg Tid, 75 mg Tid, 150 mg Tid). |
67; 72; 100 | — |
Eligibility Criteria
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 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- Patients that had previously been enrolled into this study and subsequently withdrawn.
Data sourced from ClinicalTrials.gov (NCT00419445). 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.