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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00419445
Recruitment Status : Completed
First Posted : January 8, 2007
Results First Posted : September 10, 2010
Last Update Posted : September 10, 2010
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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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: GTS21/Placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. To Assess the Safety and Tolerability of GTS21 (25 mg Tid, 75 mg Tid, 150 mg Tid). [ Time Frame: Baseline to study completion ]
    The proportion of subjects with Treatment Emergent Adverse Events.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00419445

United States, District of Columbia
George Washington University Medical Center
Washington, District of Columbia, United States
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States
Sponsors and Collaborators
Study Director: Carl Grove CoMentis (formerly Athenagen)

Additional Information:
Responsible Party: Carl Grove, CoMentis (formerly Athenagen) Identifier: NCT00419445     History of Changes
Other Study ID Numbers: GTS21-202
First Posted: January 8, 2007    Key Record Dates
Results First Posted: September 10, 2010
Last Update Posted: September 10, 2010
Last Verified: August 2010

Keywords provided by CoMentis:
Attention Deficit Hyperactivity Disorder in adults

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs