NCT01012375

Brief Summary

The purpose of this study is to determine whether 2 weeks of treatment with AZD1446 compared to placebo improves ADHD symptoms and is well tolerated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

September 2, 2011

Status Verified

September 1, 2010

Enrollment Period

9 months

First QC Date

November 11, 2009

Last Update Submit

August 31, 2011

Conditions

Adult ADHD

Keywords

Adult ADHD

Outcome Measures

Primary Outcomes (1)

  • AZD1446 compared to placebo, improves ADHD core symptoms in adult non-users and users of nicotine products after 2 weeks of treatment as measured by the Conners' Adult ADHD Rating Scale-Investigator Rated (CAARS-INV) Total ADHD Symptoms score (18 item)

    The CAARS-INV will be administered once at each of the following visits: Visit 1; Visit 2; Visits 3,4,5; Visit 7; Visits 8, 9, 10; Visit 12; and Visits 13, 14 and 15

Secondary Outcomes (3)

  • To evaluate the effect of AZD1446 treatment compared to placebo on ADHD symptoms as derived from the 30 item Conners' Adult ADHD Rating Scale-Investigator Rated (CAARS-INV) scoring

    Visit 1; Visit 2; Visits 3,4,5; Visit 7; Visits 8, 9, 10; Visit 12; and Visits 13, 14 and 15

  • To assess the safety and tolerability of effects of 2 weeks treatment with AZD1446 compared to placebo.

    From enrollment visit to follow up

  • To evaluate the pharmacokinetics (PK) of AZD1446.

    Visits 2,3, 4 7, 8, 9 12, 13 and 14 PK will be collected

Study Arms (4)

1

EXPERIMENTAL

AZD1446 tid

Drug: AZD1446

2

EXPERIMENTAL

AZD1446 tid

Drug: AZD1446

3

EXPERIMENTAL

AZD1446 qd

Drug: AZD1446

4

PLACEBO COMPARATOR

Matching placebo capsule

Drug: Placebo

Interventions

AZD1446DRUG

10 mg capsule, oral dose

1
PlaceboDRUG

Matching capsule, oral dose

4

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A confirmed diagnosis of ADHD
  • Patient understands and is willing to comply with all study requirements
  • Adults between the ages of 18-65 inclusive

You may not qualify if:

  • Current psychiatric disorder other than ADHD
  • Previous randomization into this study
  • Women with a positive pregnancy test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Research Site

Los Alamitos, California, United States

Location

Research Site

Fort Myers, Florida, United States

Location

Research Site

New York, New York, United States

Location

Research Site

Austin, Texas, United States

Location

Research Site

Burlington, Vermont, United States

Location

Research Site

Seattle, Washington, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

3-(5-chloro-2-furoyl)-3,7-diazabicyclo(3.3.0)octane

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Paul A Newhouse, MD

    Clinical Science Research Unit, Department of Psychiatry, University of Vermont,1 South Prospect Street, Burlington, VT 05401

    PRINCIPAL INVESTIGATOR

  • Bjorn Paulsson, MD

    AstraZeneca Pharmaceuticals, Kvarnbergagatan 12S-151 85, Sodertalje, Sweden

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2009

First Posted

November 13, 2009

Study Start

November 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

September 2, 2011

Record last verified: 2010-09

Locations

US(6)