A Study of ND0801 in Attention Deficit/Hyperactivity Disorder (ADHD)
This study is ongoing, but not recruiting participants.
Sponsor:
NeuroDerm Ltd.
Information provided by (Responsible Party):
NeuroDerm Ltd.
ClinicalTrials.gov Identifier:
NCT01174355
First received: August 1, 2010
Last updated: November 5, 2012
Last verified: November 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Attention Deficit and Hyperactivity Disorder |
Drug: ND0801 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: 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) |
Resource links provided by NLM:
Further study details as provided by NeuroDerm Ltd.:
Primary Outcome Measures:
- Safety & Tolerability Evaluation [ Time Frame: 1 week ] [ Designated as safety issue: No ]Safety and tolerability of ND0801 will be based on adverse events reporting by the subjects during the study.
| Estimated Enrollment: | 45 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ND0801 |
Drug: ND0801
Confidential
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| 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 More Information
No publications provided
| Responsible Party: | NeuroDerm Ltd. |
| ClinicalTrials.gov Identifier: | NCT01174355 History of Changes |
| Other Study ID Numbers: | ND0801/001 |
| Study First Received: | August 1, 2010 |
| Last Updated: | November 5, 2012 |
| Health Authority: | Israel: Ministry of Health |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders |
Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013