A Study of ND0801 in Attention Deficit/Hyperactivity Disorder (ADHD)
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A multicenter, open label, escalating dose study to assess the tolerability and the safety and to explore the efficacy and the pharmacokinetics of ND0801 in adult patients with attention deficit/hyperactivity disorder (ADHD).
A Multicenter, Open Label, Escalating Dose Study to Assess the Tolerability and the Safety and to Explore the Efficacy and the Pharmacokinetics of ND0801 in Adult Patients With Attention Deficit/Hyperactivity Disorder (ADHD)
Study Start Date
Estimated Primary Completion Date
Estimated Study Completion Date
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Ages Eligible for Study:
18 Years to 55 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Men and women 18-55 years of age.
Primary DSM-IV diagnosis of adult ADHD confirmed by senior physician
Capable and willing to provide informed consent
Able to adhere to the treatment schedule, and withdrawal of ongoing pharmacotherapy for the treatment of ADHD prior to the beginning of the study treatment and during the study drug treatment.
Subjects must be able to read, hear, write and speak the local language.
Subject has signed a written informed consent to participate in the study.
Unstable or significant medical disorder.
Current (within 12 months of baseline) primary or secondary depression.
History of substance abuse or dependence within the past 6 months
Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features
Obsessive compulsive disorder
Post-traumatic stress disorder
Current generalized anxiety disorder
Presence of a personality disorder
Individuals with a significant other neurological disorder.
Use of any investigational drug within 4 weeks of the randomization visit
Known or suspected pregnancy
Women who are breast-feeding
Women of childbearing potential and not using a medically accepted form of contraception