Overview

This trial is active, not recruiting.

Condition attention deficit and hyperactivity disorder
Treatment nd0801
Phase phase 1/phase 2
Sponsor NeuroDerm Ltd.
Start date October 2010
End date June 2013
Trial size 45 participants
Trial identifier NCT01174355, ND0801/001

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
nd0801
Confidential

Primary Outcomes

Measure
Safety & Tolerability Evaluation
time frame: 1 week

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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

Additional Information

Official title 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)
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by NeuroDerm Ltd..