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

NCT01174355 | Completed Phase 1

• 1 other identifier: ND0801/001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Safety & Tolerability Evaluation

  Safety and tolerability of ND0801 will be based on adverse events reporting by the subjects during the study.

  1 week

Study Arms (1)

ND0801

EXPERIMENTAL

Drug: ND0801

Interventions

ND0801 DRUG

Confidential

ND0801

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NeuroDerm Ltd.: lead

Study Sites (2)

Rambam Hospital

Haifa, Israel

Location

Shalvata Mental Health Center (SMHC)

Hod HaSharon, Israel

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2010
• First Posted: August 3, 2010
• Study Start: October 1, 2010
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: December 5, 2019

Record last verified: 2019-12

Locations

IL (2)