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

Attention Deficit and Hyperactivity Disorder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01174355
• Other study ID #: ND0801/001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 2010
• Est. completion date: June 2017

Study information

• Verified date: December 2019
• Source: NeuroDerm Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit and Hyperactivity Disorder
• Attention Deficit Disorder with Hyperactivity
• Hyperkinesis

Intervention

Drug:
• ND0801
Confidential

Locations

Country	Name	City	State
Israel	Rambam Hospital	Haifa
Israel	Shalvata Mental Health Center (SMHC)	Hod Hasharon

Sponsors (1)

Lead Sponsor	Collaborator
NeuroDerm Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety & Tolerability Evaluation	Safety and tolerability of ND0801 will be based on adverse events reporting by the subjects during the study.	1 week