A Study of ND0801 in 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)

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 Overview

• Status: Completed
• Conditions: Attention Deficit and Hyperactivity Disorder
• Intervention / Treatment: Drug: ND0801

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Hospital
  • Hod Hasharon, Israel
    • Shalvata Mental Health Center (SMHC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ND0801	Drug: ND0801; Confidential

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety & Tolerability Evaluation	Safety and tolerability of ND0801 will be based on adverse events reporting by the subjects during the study.	1 week

Collaborators and Investigators

• Sponsor: NeuroDerm Ltd.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: August 1, 2010
• First Submitted That Met QC Criteria: August 2, 2010
• First Posted (Estimate): August 3, 2010

Study Record Updates

• Last Update Posted (Actual): December 5, 2019
• Last Update Submitted That Met QC Criteria: December 4, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: ND0801/001