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

NCT ID: NCT01174355

Last Updated: 2019-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2017-06-30

Brief 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).

Conditions

Attention Deficit and Hyperactivity Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ND0801

Group Type: EXPERIMENTAL

ND0801

Intervention Type: DRUG

Confidential

Interventions

ND0801

Confidential

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NeuroDerm Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rambam Hospital

Haifa, , Israel

Shalvata Mental Health Center (SMHC)

Hod HaSharon, , Israel

Countries

Israel

Other Identifiers

ND0801/001

Identifier Type: -

Identifier Source: org_study_id