A Study to Evaluate the Efficacy and Safety of Two Doses of PF-03654746 in Adults With Attention Deficit Hyperactivity Disorder (ADHD).

NCT00531752 | Completed Phase 2 Results

• 2 other identifiers: A88010043-WK, CO MTD IN ADULTS W/ADHD
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to determine whether PF-03654746 is effective in the treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD). This will be a randomized, double-blind, crossover study in which adults with ADHD will receive 3 weeks of treatment with PF-03654746, either a low dose (1 mg), or flexible dose (0.50 mg titrated up to 2 mg), and 3 weeks of placebo. A washout period will separate the 2 treatment periods. Participants will be required to washout of prior ADHD medication before entering the study. Participants will be required to come to the site for 10 visits over approximately a 10-week period.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 3

  AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.

  Baseline, Week 3

Secondary Outcomes (12)

• Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 1 and 2

  Baseline, Week 1, 2

• Percentage of Participants With at Least 30 Percent Decrease From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score

  Week 1, 2, 3

• Percentage of Participants With 1 or 2 Score on Clinical Global Impression-Severity Scale (CGI-S)

  Week 1, 2, 3

• Percentage of Participants With Less Than or Equal to 18 Score on Adult ADHD Investigator Symptom Rating Scale (AISRS)

  Week 1, 2, 3

• Percentage of Participants With Sustained Response of at Least 30 Percent Decrease From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score

  Day 7, 14, 21

Other Outcomes (11)

• Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3

  Baseline, Week 1, 2, 3

• Change From Baseline in Subjective Sleep Questionnaire (SSQ) Latency Subscale Scores at Week 1, 2 and 3

  Baseline, Week 1, 2, 3

• Change From Baseline in Subjective Sleep Questionnaire (SSQ) Hours of Sleep Subscale Scores at Week 1, 2 and 3

  Baseline, Week 1, 2, 3

Study Arms (3)

Flexible Dose

EXPERIMENTAL

Drug: PF-03654746

Placebo

PLACEBO COMPARATOR

Drug: Placebo capsules

Fixed Dose

EXPERIMENTAL

Drug: PF-03654746

Interventions

PF-03654746 DRUG

Dosage Form: 0.5 mg capsules of PF-03654746 Dosage: 0.5 mg QD for Days 1-7, then 1.0 mg QD Days 8-14, then 2.0 mg QD Days 15-21

Flexible Dose

Placebo capsules DRUG

Dosage Form: matching placebo capsules Dosage: Subjects will take two placebo capsules each morning throughout the 3 week double-blind treatment placebo treatment period.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects with a diagnosis of Attention Deficit Hyperactivity Disorder, based on clinical assessment and interview.
• Male and female outpatients. Subjects with a diagnosis of Attention Deficit Hyperactivity Disorder, based on clinical assessment and interview.
• Female subjects must be of non-childbearing potential.

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular (including hypertension), hepatic, neurologic, or allergic disease.
• Current or lifetime history of psychosis or bipolar disorder; any current anxiety disorder (with the exception of social or specific phobia), or substance abuse or dependence in the past 6 months.
• Current episode of Major Depression or episode within the last 6 months.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (7)

Bay Area Research Institute

Lafayette, California, 94549, United States

Location

Pharmacology Research Institute

Los Alamitos, California, 90720, United States

Location

Pharmacology Research Institute

Newport Beach, California, 92660, United States

Location

The University of Illinois at Chicago, Institute for Juvenile Research

Chicago, Illinois, 60608, United States

Location

Massachusetts General Hospital, ADHD Program

Cambridge, Massachusetts, 02138, United States

Location

New York University School of Medicine

New York, New York, 10010, United States

Location

NeuroScience, Inc

Herndon, Virginia, 20170, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

N-ethyl-3-fluoro-3-(3-fluoro-4-(pyrrolidinylmethyl)phenyl)cyclobutanecarboxamide

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Instead of time to sustained response, data for percentage of sustained responders in time-sensitive ADHD symptom scale (TASS) total score was reported as per planned analysis.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: September 18, 2007
• First Posted: September 19, 2007
• Study Start: December 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: February 19, 2016
• Results First Posted: February 19, 2016

Record last verified: 2016-01

Locations

US (7)