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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01174355
Recruitment Status : Recruiting
First Posted : August 3, 2010
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Attention Deficit and Hyperactivity Disorder Drug: ND0801 Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : October 2010
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: ND0801 Drug: ND0801
Confidential


Outcome Measures

Primary Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01174355


Contacts
Contact: Sheila Oren, MD +9728-9462729 sheila@neuroderm.com

Locations
Israel
Rambam Hospital Recruiting
Haifa, Israel
Principal Investigator: Judith Aharon-Peretz, MD         
Shalvata Mental Health Center (SMHC) Completed
Hod Hasharon, Israel
Sponsors and Collaborators
NeuroDerm Ltd.
More Information

Responsible Party: NeuroDerm Ltd.
ClinicalTrials.gov Identifier: NCT01174355     History of Changes
Other Study ID Numbers: ND0801/001
First Posted: August 3, 2010    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms