Efficacy and Safety of NS2359 in Adults With Attention Deficit Hyperactivity Disorder

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Efficacy and Safety of NS2359 in Adults With Attention Deficit Hyperactivity Disorder. A Randomised, Double-Blind, Placebo-Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00467428
• Other study ID #: NS2359-001
• Status: Completed
• Phase: Phase 2
• First received: April 27, 2007
• Last updated: April 27, 2007
• Start date: August 2003
• Est. completion date: September 2004

Study information

• Verified date: April 2007
• Source: NeuroSearch A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to investigate if NS2359 is effective in the treatment of ADHD in adult patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• NS2359

• Placebo

Locations

Country	Name	City	State
United States	Adult and Pediatric Psychopharmacology, Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
NeuroSearch A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To investigate the safety and tolerability of NS2359 in adult ADHD patients.