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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
NeuroDerm Ltd.
ClinicalTrials.gov Identifier:
NCT01174355
First received: August 1, 2010
Last updated: November 5, 2012
Last verified: November 2012
  Purpose

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).


Condition Intervention Phase
Attention Deficit and Hyperactivity Disorder
Drug: ND0801
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by NeuroDerm Ltd.:

Primary Outcome Measures:
  • Safety & Tolerability Evaluation [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Safety and tolerability of ND0801 will be based on adverse events reporting by the subjects during the study.


Estimated Enrollment: 45
Study Start Date: October 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ND0801 Drug: ND0801
Confidential

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174355

Locations
Israel
Rambam Hospital
Haifa, Israel
Shalvata Mental Health Center (SMHC)
Hod Hasharon, Israel
Sponsors and Collaborators
NeuroDerm Ltd.
  More Information

No publications provided

Responsible Party: NeuroDerm Ltd.
ClinicalTrials.gov Identifier: NCT01174355     History of Changes
Other Study ID Numbers: ND0801/001
Study First Received: August 1, 2010
Last Updated: November 5, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014