Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

NCT00697515 | Completed Phase 3 Results

• 1 other identifier: SPD489-316
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 5

Brief Summary

To evaluate the efficacy of LDX compared to placebo in adults with ADHD in the adult workplace environment (AWE) setting

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

• Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase

  The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.

  2, 4, 8, 10, 12 and 14 hours post-dose on Day 7

Secondary Outcomes (16)

• PERMP Total Score by Timepoint in the Crossover Phase

  2, 4, 8, 10, 12 and 14 hours post-dose on Day 7

• PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase

  2, 4, 8, 10, 12 and 14 hours post-dose on Day 7

• PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase

  2, 4, 8, 10, 12 and 14 hours post-dose on Day 7

• Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale With Prompts (ADHD-RS) Total Score at up to 28 Days in the Dose Optimization Phase

  Baseline and 7, 14, 21 and 28 days

• ADHD-RS With Prompts Total Score in the Crossover Phase

  7 days

Study Arms (2)

Lisdexamfetamine Dimesylate (LDX, SPD489)

ACTIVE COMPARATOR

Drug: LDX

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

LDX DRUG

oral, 30, 50, or 70 mg once-daily for 4 weeks during dose optimization, and then for 1 week during each crossover during the adult workplace environment setting

Lisdexamfetamine Dimesylate (LDX, SPD489)

Placebo DRUG

Placebo administered once-daily for one week during the adult workplace environment setting

Placebo

Eligibility Criteria

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

You may qualify if:

• Subject must be 18-55 years of age, inclusive at the time of consent.
• Female subjects must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to comply with any applicable contraceptive requirements of the protocol.
• Subject meets Diagnostic and Statistical Manual of Mental Disorders Fourth Edition; Text Revision (DSM IV TR) criteria for a primary diagnosis of ADHD (diagnostic code 314.00 and 314.01) established by a comprehensive psychiatric evaluation that reviews DSM-IV-TR criteria with at least 6 of the 9 subtype criteria met. The Adult ADHD Clinical Diagnostic Scale version 1.2 (ACDS v1.2) will be utilized as the diagnostic tool.
• Subject has a Baseline score of \> or equal to 28 using the Adult ADHD-RS with prompts.
• Subject must have a minimum level of intellectual functioning, as determined by an Intelligent Quotient (IQ) score of 80 or above based on the Kaufman Brief Intelligence Test (KBIT).

You may not qualify if:

• Subject has a current comorbid psychiatric disorder that is either controlled with medications prohibited in this study or is uncontrolled and associated with significant symptoms. Comorbid psychiatric diagnoses will be established by the psychiatric evaluation that includes the Structured Clinical Interview for DSM-IV-TR disorders (SCID-I).
• Subjects who are currently considered a suicide risk, any subject who has previously made a suicide attempt or those who are currently demonstrating active suicidal ideation.
• Subject has a history of seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder.
• Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, transient ischemic attack or stroke or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
• Subject has current abnormal thyroid function, as defined as abnormal Screening thyroid stimulating hormone. Treatment with a stable dose of thyroid medication for at least 3 months is permitted.
• Subject has a history of moderate to severe hypertension or has a resting sitting systolic blood pressure \>139mmHg or diastolic blood pressure \>89mmHg.
• Subject has a documented allergy, hypersensitivity, or intolerance to amphetamines.
• Subject has failed to respond to one or more adequate courses (dose and duration) of amphetamine therapy.
• Subject has glaucoma.
• Subject is female and pregnant or lactating.

Sponsors & Collaborators

• Shire: lead

Study Sites (5)

Clinical Study Centers, LLC

Little Rock, Arkansas, 72205, United States

Location

University of CA, Irvine Child Development Center

Irvine, California, 92612, United States

Location

Vince & Associates Clinical Research

Overland Park, Kansas, 66212, United States

Location

Center for Psychiatry & Behavioral Medicine, Inc

Las Vegas, Nevada, 89128, United States

Location

Bayou City Research, LTD

Houston, Texas, 77007, United States

Location

Related Publications (4)

• Wigal T, Brams M, Gasior M, Gao J, Squires L, Giblin J; 316 Study Group. Randomized, double-blind, placebo-controlled, crossover study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder: novel findings using a simulated adult workplace environment design. Behav Brain Funct. 2010 Jun 24;6:34. doi: 10.1186/1744-9081-6-34.

  PMID: 20576091 RESULT

• Brams M, Giblin J, Gasior M, Gao J, Wigal T. Effects of open-label lisdexamfetamine dimesylate on self-reported quality of life in adults with ADHD. Postgrad Med. 2011 May;123(3):99-108. doi: 10.3810/pgm.2011.05.2288.

  PMID: 21566420 RESULT

• Brown TE, Brams M, Gasior M, Adeyi B, Babcock T, Dirks B, Scheckner B, Wigal T. Clinical utility of ADHD symptom thresholds to assess normalization of executive function with lisdexamfetamine dimesylate treatment in adults. Curr Med Res Opin. 2011;27 Suppl 2:23-33. doi: 10.1185/03007995.2011.605441.

  PMID: 21973229 RESULT

• Brown TE, Brams M, Gao J, Gasior M, Childress A. Open-label administration of lisdexamfetamine dimesylate improves executive function impairments and symptoms of attention-deficit/hyperactivity disorder in adults. Postgrad Med. 2010 Sep;122(5):7-17. doi: 10.3810/pgm.2010.09.2196.

  PMID: 20861583 DERIVED

Related Links

• FDA recall information

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2008
• First Posted: June 16, 2008
• Study Start: July 18, 2008
• Primary Completion: December 20, 2008
• Study Completion: December 20, 2008
• Last Updated: June 9, 2021
• Results First Posted: February 1, 2010

Record last verified: 2021-05

Locations

US (5)