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

This study has been completed.
Sponsor:
Information provided by:
CoMentis
ClinicalTrials.gov Identifier:
NCT00419445
First received: January 4, 2007
Last updated: August 16, 2010
Last verified: August 2010
  Purpose

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 Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: GTS21/Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by CoMentis:

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


Enrollment: 37
Study Start Date: February 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 < 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419445

Locations
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
CoMentis
Investigators
Study Director: Carl Grove CoMentis (formerly Athenagen)
  More Information

Additional Information:
No publications provided

Responsible Party: Carl Grove, CoMentis (formerly Athenagen)
ClinicalTrials.gov Identifier: NCT00419445     History of Changes
Other Study ID Numbers: GTS21-202
Study First Received: January 4, 2007
Results First Received: August 16, 2010
Last Updated: August 16, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by CoMentis:
Attention Deficit Hyperactivity Disorder in adults

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
3-(2,4-dimethoxybenzylidene)anabaseine
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014