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Completed

NCT Number: NCT01174355

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).

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Key information

Conditions

Attention Deficit and Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Rambam Hospital, Haifa, Israel

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ND0801

Drug

Confidential

Primary outcomes

  1. Safety & Tolerability Evaluation

    Time frame: 1 week

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

Sponsors and collaborators

Lead sponsor

NeuroDerm Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Aug 3, 2010
Registry last updated
Dec 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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