Status:
COMPLETED
A Study of ND0801 in Attention Deficit/Hyperactivity Disorder (ADHD)
Lead Sponsor:
NeuroDerm Ltd.
Conditions:
Attention Deficit and Hyperactivity Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
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/hyper...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01174355
Start Date
October 1 2010
End Date
June 1 2017
Last Update
December 5 2019
Active Locations (2)
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1
Rambam Hospital
Haifa, Israel
2
Shalvata Mental Health Center (SMHC)
Hod HaSharon, Israel