Real World Evidence of the Efficacy and Safety of FOQUEST

Last updated: September 14, 2021
Sponsor: Purdue Pharma, Canada
Overall Status: Completed

Phase

4

Condition

Williams Syndrome

Attention Deficit/hyperactivity Disorder (Adhd - Adults)

Treatment

N/A

Clinical Study ID

NCT04152629
CAN-MA-FOQ-001
  • Ages > 6
  • All Genders

Study Summary

This study is a four-month, phase IV, open-label study of ADHD symptomatology and functional outcomes in pediatric (6 to 17 years old) and adult (≥18 years or older) patients with ADHD treated with FOQUEST or VYVANSE.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Pediatric: Male or non-pregnant, non-nursing female patients the age of 6 to less than
  2. Adults: Male or non-pregnant, non-nursing female patients the age of 18 or older.
  3. Diagnosed with ADHD (inattentive, hyperactive or combined-type) who are deemedeligible to receive treatment with FOQUEST or VYVANSE, as per the respective ProductMonograph.
  4. Mentally and physically competent to provide informed consent, or assent and able andwilling to comply with the study protocol, including the study duration.

Exclusion

Exclusion Criteria: Potential patients who meet any of the contraindications or warnings detailed in therespective Canadian Product Monographs are excluded from participation in the study:

  1. Having a true allergy to methylphenidate or amphetamines or sympathomimetic amines,history of serious adverse reactions to methylphenidate or amphetamines or be known tobe non-responsive to methylphenidate or amphetamine treatment. Non-response is definedas methylphenidate or amphetamine use at various doses for a phase of at least fourweeks at each dose with little or no clinical benefit in the past 10 years.
  2. Females of child-bearing potential (FOCP) who are pregnant, planning on becomingpregnant or breast feeding.
  3. Having a history of hyperthyroidism, thyrotoxicosis, advanced arteriosclerosis, severerenal insufficiency or glaucoma.
  4. Having structural cardiac abnormalities, symptomatic cardiovascular disease ormoderate to severe hypertension.
  5. Currently, or within the past 14 days, receiving MAO inhibitors.
  6. Having a primary diagnosis of bipolar disorder, as assessed at Visit 1.
  7. Currently receiving any investigational drug, or have received an investigational drugin the previous month.
  8. Having a history of drug or alcohol abuse or dependence.
  9. Currently considered a suicide risk by the Investigator.

Study Design

Total Participants: 257
Study Start date:
September 19, 2019
Estimated Completion Date:
July 09, 2021

Study Description

After giving written, informed consent or assent (for patients <18 years old), patients will be screened to ascertain their suitability for the study according to the patient selection criteria (Section 4). Based on clinician assessment, patients will be assigned to receive either FOQUEST or VYVANSE. Patients will be titrated to their optimal dose of ADHD medication based on Investigator judgement. At monthly visits, patients will have their ADHD symptomatology evaluated by the Investigator (ADHD-Rating Scale-DSM 5 Version [ADHD-RS-5]) and will complete questionnaires on functional outcomes (Weiss Functional Impairment Ratings Scale - Parent [WFIRS-P] or Weiss Functional Impairment Ratings Scale - Self [WFIRS-Self]), morning and evening behaviours (Daily Parent Rating of Evening and Morning Behaviours - Revised [DPREMB-R] or Adult ADHD Quality of Life Rating Scale - Revised [AAQoL-R]) and Patient Sleep & Satisfaction survey (PSS). Safety will be evaluated through non-directed spontaneous adverse event (AE) reporting. Patients will be monitored for signs of suicide-related behavior, as per standard of care. A post-study safety follow-up phone call (conducted between 7 and 14 days post-last visit) will assess patients for any adverse events that occur following their last dose of medication received as part of the study. Following the last dose of study medication, the patient's continuing, post-study ADHD treatment will be based on Investigator discretion and standard of care.

Connect with a study center

  • Matheson Centre for Mental Health Research & Education, University of Calgary

    Calgary, Alberta T2N 4Z6
    Canada

    Site Not Available

  • Adult ADHD Centeres at Pacific Coast Recovery Care

    Burnaby, British Columbia V3N 3N4
    Canada

    Site Not Available

  • Medical Arts Health Research Group

    Burnaby, British Columbia V7T 1C5
    Canada

    Site Not Available

  • The Kids Clinic Inc.

    Ajax, Ontario L1Z 0M1
    Canada

    Site Not Available

  • Chatham-Kent Clinical Trials Research Centre

    Chatham, Ontario N7L 1C1
    Canada

    Site Not Available

  • Pediatric Institute of Excellence

    Etobicoke, Ontario M9V 4C2
    Canada

    Site Not Available

  • Center for Pediatric Excellence

    Ottawa, Ontario K2G1W2
    Canada

    Site Not Available

  • Health Sciences North

    Sudbury, Ontario P3E 5J1
    Canada

    Site Not Available

  • ADDClinic Windsor

    Windsor, Ontario N8X 4X9
    Canada

    Site Not Available

  • Recherche Clinique Sigma Inc

    Quebec City, Quebec G1G 3Y8
    Canada

    Site Not Available

  • Alpha recherche clinique

    Québec, Quebec G2J 0C4
    Canada

    Site Not Available

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