An Exploratory Trial of AZD3480 (TC-1734) for the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD) - Full Text View

Sponsors and Collaborators:	AstraZeneca Targacept Inc.
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00683462

Purpose

A 3-way cross-over trial of two weeks of treatment with three drug conditions. AZD3480 will be given in doses of (A) 5mg/day, (B) 50 mg/day and (C) placebo to 24 non-smoking adults with DSM-IV confirmed ADHD. Three week washout between each treatment period. CYP2D6 genotyping will be completed at screening and slow metabolisers will be excluded from participation in this study. Cognitive, ADHD symptom, safety and pharmacokinetic (PK) assessments will be made during each treatment period. Safety and tolerability assessments will be a major component of the trial and all serious adverse events (SAE) will be immediately (within 24 hours) reported to both Targacept and to AstraZenca.

Condition	Intervention	Phase
ADHD	Drug: Placebo Drug: AZD3480	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Efficacy Study
Official Title:	An Exploratory Trial of AZD3480 (TC-1734) for the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD)

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The Total Symptoms Scale Score (of ADHD) of the Connors Adult ADHD Rating Scale-Investigator Rating (CAARS-INV). [ Time Frame: Visit 1, 2, 3, 4, 5, 8, 9, 10,13, 14 and 15 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical Global Impressions Scales (NIMH 1985) [ Time Frame: Visit 1, 2, 3, 4, 5, 8, 9, 10, 13, 14,15 ] [ Designated as safety issue: No ]
CDR computerized cognitive battery [ Time Frame: 2, 3, 5, 8, 10, 13, 15 ] [ Designated as safety issue: No ]
CNRU computerized cognitive battery [ Time Frame: 2, 3, 5, 8, 10, 13, 15 ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	May 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: Placebo
2: Experimental	Drug: AZD3480 Capsules 5 mg/day (once a day) for 2 weeks
3: Experimental	Drug: AZD3480 Capsules 50 mg/day (once a day) for 2 weeks

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed diagnosis of DSM-IV ADHD
Score of equal or more than 2 on at least six of nine items in at least one of the subscales of the Connor´s Adult ADHD Rating Scale (CAARS-INV)
Score of equal or more than 4 (at least moderate severity) on the Clinical Global Impressions-Severity (CGI-S) test

Exclusion Criteria:

Current DSM-IV Axis I psychiatric disorder (other than ADHD)
Current user of cigarettes or other nicotine-containing product.
Slow metabolizers as indicated by CYP2D6 genotyping.
Use of drugs affecting cognitive function within 8 weeks prior to enrollment visit or intended use during the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683462

Contacts

Contact: David Hosford, MD

+1 919 480-2137

david.hosford@targacept.com

Locations

United States, Vermont
Research Site	Recruiting
Burlington, Vermont, United States

Sponsors and Collaborators

AstraZeneca

Targacept Inc.

More Information

Responsible Party:	AstraZeneca R&D, Södertälje ( Hans-Göran Hårdemark, MD, PhD, Medical Science Director AZD3480 )
Study ID Numbers:	TC-1734-226-CRD-005
Study First Received:	May 21, 2008
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00683462
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis

ClinicalTrials.gov processed this record on January 16, 2009