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

Primary Purpose

ADHD

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
AZD3480
AZD3480
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

The Total Symptoms Scale Score (of ADHD) of the Connors Adult ADHD Rating Scale-Investigator Rating (CAARS-INV).

Secondary Outcome Measures

Clinical Global Impressions Scales (NIMH 1985)
CDR computerized cognitive battery
CNRU computerized cognitive battery

Full Information

First Posted
May 21, 2008
Last Updated
October 29, 2009
Sponsor
AstraZeneca
Collaborators
Targacept Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00683462
Brief Title
An Exploratory Trial of AZD3480 (TC-1734) for the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD)
Official Title
An Exploratory Trial of AZD3480 (TC-1734) for the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca
Collaborators
Targacept Inc.

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
AZD3480
Intervention Description
Capsules 5 mg/day (once a day) for 2 weeks
Intervention Type
Drug
Intervention Name(s)
AZD3480
Intervention Description
Capsules 50 mg/day (once a day) for 2 weeks
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Clinical Global Impressions Scales (NIMH 1985)
Time Frame
Visit 1, 2, 3, 4, 5, 8, 9, 10, 13, 14,15
Title
CDR computerized cognitive battery
Time Frame
2, 3, 5, 8, 10, 13, 15
Title
CNRU computerized cognitive battery
Time Frame
2, 3, 5, 8, 10, 13, 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Research Site
City
Burlington
State/Province
Vermont
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23856296
Citation
Potter AS, Dunbar G, Mazzulla E, Hosford D, Newhouse PA. AZD3480, a novel nicotinic receptor agonist, for the treatment of attention-deficit/hyperactivity disorder in adults. Biol Psychiatry. 2014 Feb 1;75(3):207-14. doi: 10.1016/j.biopsych.2013.06.002. Epub 2013 Jul 12.
Results Reference
derived

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

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