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

NCT00683462 | Completed Phase 2

• 1 other identifier: TC-1734-226-CRD-005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

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

  Visit 1, 2, 3, 4, 5, 8, 9, 10,13, 14 and 15

Secondary Outcomes (3)

• Clinical Global Impressions Scales (NIMH 1985)

  Visit 1, 2, 3, 4, 5, 8, 9, 10, 13, 14,15

• CDR computerized cognitive battery

  2, 3, 5, 8, 10, 13, 15

• CNRU computerized cognitive battery

  2, 3, 5, 8, 10, 13, 15

Study Arms (3)

1

PLACEBO COMPARATOR

Drug: Placebo

2

EXPERIMENTAL

Drug: AZD3480

3

EXPERIMENTAL

Drug: AZD3480

Interventions

Placebo DRUG

1

AZD3480 DRUG

Capsules 5 mg/day (once a day) for 2 weeks

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Targacept Inc.: collaborator

Study Sites (1)

Research Site

Burlington, Vermont, United States

Location

Related Publications (1)

• 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.

  PMID: 23856296 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

ispronicline

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 21, 2008
• First Posted: May 23, 2008
• Study Start: May 1, 2008
• Study Completion: July 1, 2009
• Last Updated: October 30, 2009

Record last verified: 2009-10

Locations

US (1)