Attention Deficit Hyperactivity DisorderPhase 2NCT00467428
Efficacy and Safety of NS2359 in Adults With Attention Deficit Hyperactivity Disorder
A Phase 2 study testing NS2359 in people with Attention Deficit Hyperactivity Disorder, run by NeuroSearch A/S at 1 site in United States.
Trial summary
The purpose of the study is to investigate if NS2359 is effective in the treatment of ADHD in adult patients. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- NS2359
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Sep 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview using the K-SADS-E adult ADHD module
- Patients with a CGI Global Severity (GS) score ≥4 (moderate impairment)
- The Patient provided written informed consent.
- Non-lactating women of childbearing potential that used adequate contraception (i.e. the use of oral contraceptives and practising a double-barrier form of birth control) and had a negative pregnancy test at screening. Women of no childbearing potential who had been postmenopausal for less than 2 years must have a negative pregnancy test at screening.
Who cannot join
- Any clinically unstable medical condition
- Clinically significant abnormal baseline laboratory values
- Mental retardation
- Organic brain disorders
- Non-febrile seizure disorder
- Patients with a history of an eating disorder including anorexia or bulimia nervosa
Show all 19Show fewer
- Psychotic disorder of any type
- Patients with a HAM-D (17 item) >15
- Patients currently (within the past 6 months) known to abuse or to be dependent on any drug, including alcohol or a positive urine drug screen for cocaine, heroin, or marijuana
- Treatment with stimulants was prohibited within 1 week prior to randomisation
- Treatment with antipsychotics/neuroleptics was prohibited for 8 weeks prior to randomisation
- Treatment with monoamine oxidase inhibitors was prohibited for 8 weeks prior to randomisation
- Treatment with tricyclic antidepressants, histamines and selective serotonin reuptake inhibitors was prohibited for 4 weeks (fluoxetine for 6 weeks) prior to randomisation
- Treatment with benzodiazepines, anticonvulsants (for behaviour) and lithium for 2 weeks prior to randomisation
- Patients with a history of bipolar disorder
- Patients using any concurrent medication for the treatment of ADHD
- Patients that had previously participated in a NS2359 study
- Patients treated with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication
- Patients with a history of positive human immunodeficiency virus (HIV) test.
Trial locations and contacts
1 site in 1 country.
United States1 site
Adult and Pediatric Psychopharmacology, Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Efficacy and Safety of NS2359 in Adults With Attention Deficit Hyperactivity Disorder. A Randomised, Double-Blind, Placebo-Controlled Study
The purpose of the study is to investigate if NS2359 is effective in the treatment of ADHD in adult patients.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- NS2359, Placebo
- Keywords
- ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NS2359Drug
PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the efficacy of NS2359 in adult patients diagnosed with ADHD (predominantly inattentive, predominantly hyperactive/impulsive or combined) according to DSM-IV criteria.
Secondary outcomes (1)
To investigate the safety and tolerability of NS2359 in adult ADHD patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2007 (estimated)
- Study startAug 2003
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroSearch A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thimothy Wilens, MD, Principal investigator, Adult and Pediatric Psychopharmacology, Masschusetts General Hospial, Boston, US
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467428
- Sponsor's protocol ID
- NS2359-001
- Status last verified
- Apr 2007
- First submitted
- 27 Apr 2007
- Last updated
- 30 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of NS2359 in Adults With Attention Deficit Hyperactivity Disorder. A Randomised, Double-Blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT00467428
- Acronym / sponsor ID
- NS2359-001
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- NeuroSearch A/SIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Study completion
- Sep 2004 (actual)
- First posted
- 30 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to investigate if NS2359 is effective in the treatment of ADHD in adult patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview using the K-SADS-E adult ADHD module
- Patients with a CGI Global Severity (GS) score ≥4 (moderate impairment)
- The Patient provided written informed consent.
- Non-lactating women of childbearing potential that used adequate contraception (i.e. the use of oral contraceptives and practising a double-barrier form of birth control) and had a negative pregnancy test at screening. Women of no childbearing potential who had been postmenopausal for less than 2 years must have a negative pregnancy test at screening.
Key exclusion criteria (19 listed)
- Any clinically unstable medical condition
- Clinically significant abnormal baseline laboratory values
- Mental retardation
- Organic brain disorders
- Non-febrile seizure disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NS2359 | Drug | – |
| Placebo | Drug | – |
Primary outcome
To investigate the efficacy of NS2359 in adult patients diagnosed with ADHD (predominantly inattentive, predominantly hyperactive/impulsive or combined) according to DSM-IV criteria.
1 secondary outcome
To investigate the safety and tolerability of NS2359 in adult ADHD patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2007.
Related trials for Attention Deficit Hyperactivity Disorder
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thimothy Wilens, MD principal investigator
Adult and Pediatric Psychopharmacology, Masschusetts General Hospial, Boston, US
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NS2359 in people with Attention Deficit Hyperactivity Disorder, run by NeuroSearch A/S at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the efficacy of NS2359 in adult patients diagnosed with ADHD (predominantly inattentive, predominantly hyperactive/impulsive or combined) according to DSM-IV criteria.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2007.