Back to resultsA Study of ND0801 in Attention Deficit/Hyperactivity Disorder (ADHD)
Primary Purpose
Attention Deficit and Hyperactivity Disorder
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
ND0801
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit and Hyperactivity Disorder
Eligibility 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
Sites / Locations
- Rambam Hospital
- Shalvata Mental Health Center (SMHC)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ND0801
Arm Description
Outcomes
Primary Outcome Measures
Safety & Tolerability Evaluation
Safety and tolerability of ND0801 will be based on adverse events reporting by the subjects during the study.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01174355
Brief Title
A Study of ND0801 in Attention Deficit/Hyperactivity Disorder (ADHD)
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 Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeuroDerm Ltd.
4. Oversight
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit and Hyperactivity Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ND0801
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ND0801
Intervention Description
Confidential
Primary Outcome Measure Information:
Title
Safety & Tolerability Evaluation
Description
Safety and tolerability of ND0801 will be based on adverse events reporting by the subjects during the study.
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Rambam Hospital
City
Haifa
Country
Israel
Facility Name
Shalvata Mental Health Center (SMHC)
City
Hod Hasharon
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
A Study of ND0801 in Attention Deficit/Hyperactivity Disorder (ADHD)
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