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

This study has been completed.
Sponsor:
Collaborator:
Targacept Inc.
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00683462
First received: May 21, 2008
Last updated: October 29, 2009
Last verified: October 2009
History of Changes
  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 2

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

Resource links provided by NLM:

U.S. FDA Resources

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
Study Completion Date: July 2009
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo
Experimental: 2 Drug: AZD3480
Capsules 5 mg/day (once a day) for 2 weeks
Other Name: AZD3480
Experimental: 3 Drug: AZD3480
Capsules 50 mg/day (once a day) for 2 weeks
Other Name: AZD3480

  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

Locations
United States, Vermont
Research Site
Burlington, Vermont, United States
Sponsors and Collaborators
AstraZeneca
Targacept Inc.
  More Information

No publications provided

Responsible Party: Hans-Göran Hårdemark, MD, PhD, Medical Science Director AZD3480, AstraZeneca R&D, Södertälje
ClinicalTrials.gov Identifier: NCT00683462     History of Changes
Obsolete Identifiers: NCT00683215
Other Study ID Numbers: TC-1734-226-CRD-005
Study First Received: May 21, 2008
Last Updated: October 29, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on June 17, 2013