Effect of Guanfacine Extended-Release on Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia

NCT01156051 | Terminated Phase 4 Results DMC

• 1 other identifier: CSHTR-TR-0901
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

This study seeks to determine, using special sleep tests (polysomnography and actigraphy) if guanfacine extended release is able to improve nighttime sleep in children with ADHD - associated insomnia while improving daytime ADHD symptoms. Male and female children with diagnosed or suspected ADHD with sleep problems (difficulty falling asleep, difficulty staying asleep, or less than expected hours of sleep) will be recruited. After obtaining informed consent and assent (when appropriate) and after discontinuation of excluded medications, children will have evaluations of his or her sleep and evaluations confirming the ADHD diagnosis. Children who successfully pass screening will be enrolled into the double-blind, placebo-controlled, randomized investigation with 50% of participants receiving guanfacine extended release and 50% of participants receiving matching placebo. Using a flexible-dose optimization design based on ADHD symptom improvement and medication tolerability, the dose will be adjusted between 1 to 4 mg over the course of four weeks. At the end of medication adjustment (week 4 or 5), ADHD questionnaires, sleep questionnaires, and sleep tests will be repeated and analyzed. The medication will be weaned over the course of the following 3-10 days.

Conditions

Attention-Deficit/Hyperactivity Disorder; Attention Deficit Disorder; Insomnia; Sleep Disorders

Keywords

ADHD; ADD; sleep disturbance

Outcome Measures

Primary Outcomes (1)

• Change in Polysomnographic Total Sleep Time (TST)

  Change in objective measures of sleep, using polysomnography

  Baseline to last observation carried forward (after at least one week of dose stability)

Secondary Outcomes (3)

• Change in Baseline to Treatment ADHD-Rating Scale IV Total Score

  Baseline to last observation carried forward (after at least one week of dose stability)

• Change in Baseline to Treatment Latency to Persistent Sleep (LPS)

  Baseline to last observation carried forward (after at least one week of dose stability)

• Change in Baseline to Treatment Minutes of Wake Time After Sleep Onset (WASO)

  Baseline to last observation carried forward (after at least one week of dose stability)

Study Arms (2)

Guanfacine Extended-Release Tablets

EXPERIMENTAL

Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg

Drug: Guanfacine extended-release tablets

Placebo comparator

PLACEBO COMPARATOR

Placebo control

Drug: Placebo comparator

Interventions

Guanfacine extended-release tablets DRUG

Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated

Also known as: Intuniv (TM), guanfacine HCl, SPD503

Guanfacine Extended-Release Tablets

Placebo comparator DRUG

Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine).

Also known as: "sugar pill"

Placebo comparator

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subject must be male or female, aged 6 - 12 years with ADHD.
• Subject must (a) be taking methylphenidate, amphetamine, or atomoxetine for treatment of ADHD with parent or subject concerns of inadequate efficacy or intolerable side effects, or (b) free of any other medication used to treat ADHD for at least 30 days at the time of the initial sleep study.
• Subject must have repeated difficulty with sleep initiation or persistence despite attempts at adequate sleep hygiene.
• Subject must be able to swallow tablets.

You may not qualify if:

• Subject or parent/LAR is unable or unwilling to discontinue present medications used to treat ADHD.
• Subject has a body mass index \< 5th percentile for age, using the Centers for Disease Control standards reported in 2000.
• Subject has a body weight \> 176 pounds.
• Subject has a diagnosis of Autism or Autism Spectrum Disorder.
• Subject has other serious psychiatric diagnoses.
• Subject has a medical condition that may require treatment with an unapproved medication, that may cause a safety concern, or that may confound outcome results
• Subject has an excessive caffeine intake (greater than 2.5 mg/kg/d).
• Subject has a prior problem with clonidine or guanfacine.

Sponsors & Collaborators

• Children's Specialized Hospital: lead
• Shire: collaborator

Study Sites (2)

Children's Specialized Hospital

Hamilton, New Jersey, 08619, United States

Location

Children's Specialized Hospital

Toms River, New Jersey, 08755, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Parasomnias

Interventions

Guanfacine; Sugars

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Carbohydrates

Results Point of Contact

• Title: Thomas A Rugino MD
• Organization: Children's Specialized Hospital

trugino@childrens-specialized.org

732-797-3826

Study Officials

• Thomas A Rugino, MD

  Children's Specialized Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2010
• First Posted: July 2, 2010
• Study Start: June 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: August 11, 2014
• Results First Posted: August 11, 2014

Record last verified: 2014-07

Locations

US (2)