Safety and Efficacy of GTS21 in Adults With Attention-deficit Hyperactivity Disorder

A Double-Blind, Randomized, Proof-of-Concept Crossover Trial to Assess the Effects of GTS21 on Cognitive Function, Clinical Symptoms, and Adverse Events in Adults Diagnosed With Attention-Deficit Hyperactivity Disorder

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Drug: GTS21/Placebo

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States
      • George Washington University Medical Center
  • North Carolina
    • Durham, North Carolina, United States
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GTS21 25 mg tid/Placebo 25 mg tid	Drug: GTS21/Placebo
Active Comparator: GTS21 75 mg tid/Placebo 75 mg tid	Drug: GTS21/Placebo
Active Comparator: GTS21 150 mg tid/Placebo 150 mg tid	Drug: GTS21/Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to study completion

Collaborators and Investigators

• Sponsor: CoMentis
• Investigators: Study Director: Carl Grove, CoMentis (formerly Athenagen)

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: January 4, 2007
• First Submitted That Met QC Criteria: January 5, 2007
• First Posted (Estimate): January 8, 2007

Study Record Updates

• Last Update Posted (Estimate): September 10, 2010
• Last Update Submitted That Met QC Criteria: August 16, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Attention Deficit Hyperactivity Disorder in adults
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Disease; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; 3-(2,4-dimethoxybenzylidene)anabaseine
• Other Study ID Numbers: GTS21-202