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Real World Evidence of the Efficacy and Safety of FOQUEST (reFOQus)

Primary Purpose

Attention Deficit-Hyperactivity Disorder

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Methylphenidate Hydrochloride
Lisdexamfetamine Dimesylate
Sponsored by
Purdue Pharma, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit-Hyperactivity Disorder

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Potential patients who meet any of the contraindications or warnings detailed in the respective 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 to be non-responsive to methylphenidate or amphetamine treatment. Non-response is defined as methylphenidate or amphetamine use at various doses for a phase of at least four weeks 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 becoming pregnant or breast feeding.
  3. Having a history of hyperthyroidism, thyrotoxicosis, advanced arteriosclerosis, severe renal insufficiency or glaucoma.
  4. Having structural cardiac abnormalities, symptomatic cardiovascular disease or moderate 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 drug in the previous month.
  8. Having a history of drug or alcohol abuse or dependence.
  9. Currently considered a suicide risk by the Investigator.

Sites / Locations

  • Matheson Centre for Mental Health Research & Education, University of Calgary
  • Adult ADHD Centeres at Pacific Coast Recovery Care
  • Medical Arts Health Research Group
  • The Kids Clinic Inc.
  • Chatham-Kent Clinical Trials Research Centre
  • Pediatric Institute of Excellence
  • Center for Pediatric Excellence
  • Health Sciences North
  • ADDClinic Windsor
  • Recherche Clinique Sigma Inc
  • Alpha recherche clinique
  • Alpha recherche clinique

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

FOQUEST adults

VYVANSE adults

FOQUEST pediatric

VYVANSE pediatric

Arm Description

adult (≥18 years or older) patients with ADHD receiving FOQUEST (controlled-release methylphenidate 25 mg, 35 mg, 45 mg, 55 mg, 70 mg, 85 mg, or 100 mg/day)

adult (≥18 years or older) patients with ADHD receiving VYVANSE (lisdexamfetamine 10 mg, 20 mg, 30 mg, 40 mg, 50 mg or 60 mg/day)

pediatric (6 to 17 years old) patients with ADHD receiving FOQUEST (controlled-release methylphenidate 25 mg, 35 mg, 45 mg, 55 mg or 70 mg/day)

pediatric (6 to 17 years old) patients with ADHD receiving VYVANSE (lisdexamfetamine 10 mg, 20 mg, 30 mg, 40 mg, 50 mg or 60 mg/day)

Outcomes

Primary Outcome Measures

Change in ADHD Rating Scale Total Score
The ADHD Rating Scale DSM-5 (ADHD-RS-5) is a clinician-rated scale that reflects current symptoms of ADHD based on DSM-5 criteria. It is a global assessment that measures the severity of symptoms from visit to visit, but is not utilized to assess symptoms of ADHD over the course of the day. The ADHD-RS-5 consists of 18 items that are grouped into two subscales (hyperactivity/impulsivity, and inattention). Higher score means higher frequency and severity of symptoms.

Secondary Outcome Measures

Non-Inferiority Comparison between Treatments in Change in ADHD Rating Scale Total Score
The ADHD Rating Scale DSM-5 (ADHD-RS-5) is a clinician-rated scale that reflects current symptoms of ADHD based on DSM-5 criteria. It is a global assessment that measures the severity of symptoms from visit to visit, but is not utilized to assess symptoms of ADHD over the course of the day. The ADHD-RS-5 consists of 18 items that are grouped into two subscales (hyperactivity/impulsivity, and inattention). Higher score means higher frequency and severity of symptoms.

Full Information

First Posted
October 31, 2019
Last Updated
September 14, 2021
Sponsor
Purdue Pharma, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT04152629
Brief Title
Real World Evidence of the Efficacy and Safety of FOQUEST
Acronym
reFOQus
Official Title
A Phase IV, Real World, Open-label, Multi-centre Study on the Use of FOQUEST® (Methylphenidate Hydrochloride Controlled-release Capsules) for the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Pediatric and Adult Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 19, 2019 (Actual)
Primary Completion Date
July 9, 2021 (Actual)
Study Completion Date
July 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Purdue Pharma, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit-Hyperactivity Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
257 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FOQUEST adults
Arm Type
Experimental
Arm Description
adult (≥18 years or older) patients with ADHD receiving FOQUEST (controlled-release methylphenidate 25 mg, 35 mg, 45 mg, 55 mg, 70 mg, 85 mg, or 100 mg/day)
Arm Title
VYVANSE adults
Arm Type
Active Comparator
Arm Description
adult (≥18 years or older) patients with ADHD receiving VYVANSE (lisdexamfetamine 10 mg, 20 mg, 30 mg, 40 mg, 50 mg or 60 mg/day)
Arm Title
FOQUEST pediatric
Arm Type
Experimental
Arm Description
pediatric (6 to 17 years old) patients with ADHD receiving FOQUEST (controlled-release methylphenidate 25 mg, 35 mg, 45 mg, 55 mg or 70 mg/day)
Arm Title
VYVANSE pediatric
Arm Type
Active Comparator
Arm Description
pediatric (6 to 17 years old) patients with ADHD receiving VYVANSE (lisdexamfetamine 10 mg, 20 mg, 30 mg, 40 mg, 50 mg or 60 mg/day)
Intervention Type
Drug
Intervention Name(s)
Methylphenidate Hydrochloride
Other Intervention Name(s)
FOQUEST, ADHANSIA XR
Intervention Description
CR Methylphenidate Hydrochloride given once daily (25 mg, 35 mg, 45 mg, 55 mg, 70 mg, 85 mg or 100 mg)
Intervention Type
Drug
Intervention Name(s)
Lisdexamfetamine Dimesylate
Other Intervention Name(s)
VYVANSE
Intervention Description
Lisdexamfetamine Dimesylate given once daily (10 mg, 20 mg, 30 mg, 40 mg, 50 mg or 60 mg)
Primary Outcome Measure Information:
Title
Change in ADHD Rating Scale Total Score
Description
The ADHD Rating Scale DSM-5 (ADHD-RS-5) is a clinician-rated scale that reflects current symptoms of ADHD based on DSM-5 criteria. It is a global assessment that measures the severity of symptoms from visit to visit, but is not utilized to assess symptoms of ADHD over the course of the day. The ADHD-RS-5 consists of 18 items that are grouped into two subscales (hyperactivity/impulsivity, and inattention). Higher score means higher frequency and severity of symptoms.
Time Frame
Change from Baseline ADHD Rating Scale Total Score at 4 months
Secondary Outcome Measure Information:
Title
Non-Inferiority Comparison between Treatments in Change in ADHD Rating Scale Total Score
Description
The ADHD Rating Scale DSM-5 (ADHD-RS-5) is a clinician-rated scale that reflects current symptoms of ADHD based on DSM-5 criteria. It is a global assessment that measures the severity of symptoms from visit to visit, but is not utilized to assess symptoms of ADHD over the course of the day. The ADHD-RS-5 consists of 18 items that are grouped into two subscales (hyperactivity/impulsivity, and inattention). Higher score means higher frequency and severity of symptoms.
Time Frame
Change from Baseline ADHD Rating Scale Total Score at 4 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pediatric: Male or non-pregnant, non-nursing female patients the age of 6 to less than 18. Adults: Male or non-pregnant, non-nursing female patients the age of 18 or older. Diagnosed with ADHD (inattentive, hyperactive or combined-type) who are deemed eligible to receive treatment with FOQUEST or VYVANSE, as per the respective Product Monograph. Mentally and physically competent to provide informed consent, or assent and able and willing to comply with the study protocol, including the study duration. Exclusion Criteria: Potential patients who meet any of the contraindications or warnings detailed in the respective Canadian Product Monographs are excluded from participation in the study: Having a true allergy to methylphenidate or amphetamines or sympathomimetic amines, history of serious adverse reactions to methylphenidate or amphetamines or be known to be non-responsive to methylphenidate or amphetamine treatment. Non-response is defined as methylphenidate or amphetamine use at various doses for a phase of at least four weeks at each dose with little or no clinical benefit in the past 10 years. Females of child-bearing potential (FOCP) who are pregnant, planning on becoming pregnant or breast feeding. Having a history of hyperthyroidism, thyrotoxicosis, advanced arteriosclerosis, severe renal insufficiency or glaucoma. Having structural cardiac abnormalities, symptomatic cardiovascular disease or moderate to severe hypertension. Currently, or within the past 14 days, receiving MAO inhibitors. Having a primary diagnosis of bipolar disorder, as assessed at Visit 1. Currently receiving any investigational drug, or have received an investigational drug in the previous month. Having a history of drug or alcohol abuse or dependence. Currently considered a suicide risk by the Investigator.
Facility Information:
Facility Name
Matheson Centre for Mental Health Research & Education, University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Adult ADHD Centeres at Pacific Coast Recovery Care
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V3N 3N4
Country
Canada
Facility Name
Medical Arts Health Research Group
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V7T 1C5
Country
Canada
Facility Name
The Kids Clinic Inc.
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1Z 0M1
Country
Canada
Facility Name
Chatham-Kent Clinical Trials Research Centre
City
Chatham
State/Province
Ontario
ZIP/Postal Code
N7L 1C1
Country
Canada
Facility Name
Pediatric Institute of Excellence
City
Etobicoke
State/Province
Ontario
ZIP/Postal Code
M9V 4C2
Country
Canada
Facility Name
Center for Pediatric Excellence
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2G1W2
Country
Canada
Facility Name
Health Sciences North
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
ADDClinic Windsor
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 4X9
Country
Canada
Facility Name
Recherche Clinique Sigma Inc
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1G 3Y8
Country
Canada
Facility Name
Alpha recherche clinique
City
Québec
State/Province
Quebec
ZIP/Postal Code
G2J 0C4
Country
Canada
Facility Name
Alpha recherche clinique
City
Québec
State/Province
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Real World Evidence of the Efficacy and Safety of FOQUEST

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