A Study of ND0801 in Attention Deficit/Hyperactivity Disorder (ADHD)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: August 1, 2010
Last updated: November 5, 2012
Last verified: November 2012
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).
Attention Deficit and Hyperactivity Disorder
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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)
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2013 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
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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
|Haifa, Israel |
|Shalvata Mental Health Center (SMHC)
|Hod Hasharon, Israel |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 1, 2010
||November 5, 2012
||Israel: Ministry of Health
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 19, 2014
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Signs and Symptoms