- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00683462
An Exploratory Trial of AZD3480 (TC-1734) for the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD)
October 29, 2009 updated by: AstraZeneca
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Vermont
-
Burlington, Vermont, United States
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 2
|
Capsules 5 mg/day (once a day) for 2 weeks
Capsules 50 mg/day (once a day) for 2 weeks
|
Placebo Comparator: 1
|
|
Experimental: 3
|
Capsules 5 mg/day (once a day) for 2 weeks
Capsules 50 mg/day (once a day) for 2 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Visit 1, 2, 3, 4, 5, 8, 9, 10,13, 14 and 15
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical Global Impressions Scales (NIMH 1985)
Time Frame: Visit 1, 2, 3, 4, 5, 8, 9, 10, 13, 14,15
|
Visit 1, 2, 3, 4, 5, 8, 9, 10, 13, 14,15
|
CDR computerized cognitive battery
Time Frame: 2, 3, 5, 8, 10, 13, 15
|
2, 3, 5, 8, 10, 13, 15
|
CNRU computerized cognitive battery
Time Frame: 2, 3, 5, 8, 10, 13, 15
|
2, 3, 5, 8, 10, 13, 15
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
May 21, 2008
First Submitted That Met QC Criteria
May 21, 2008
First Posted (Estimate)
May 23, 2008
Study Record Updates
Last Update Posted (Estimate)
October 30, 2009
Last Update Submitted That Met QC Criteria
October 29, 2009
Last Verified
October 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TC-1734-226-CRD-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on ADHD
-
The Hong Kong Polytechnic UniversityRecruiting
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)Recruiting
-
VIZO Specs LtdRecruiting
-
Loewenstein HospitalWingate InstituteRecruiting
-
Florida State UniversityRecruiting
-
Florida International UniversityRecruiting
-
Region Örebro CountyRecruiting
-
Johns Hopkins UniversityWithdrawn
-
Tris Pharma, Inc.Premier Research Group plcCompleted
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States