A Study of ND0801 in Attention Deficit/Hyperactivity Disorder (ADHD)

NeuroDerm

Status and phase

Completed

Phase 2

Phase 1

Conditions

Attention Deficit and Hyperactivity Disorder

Treatments

Drug: ND0801

Study type

Interventional

Funder types

Industry

Identifiers

NCT01174355

ND0801/001

Details and patient eligibility

About

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).

Enrollment

40 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Outpatients.
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.

Exclusion criteria

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
Bipolar disorder
Eating disorder
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