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

September 14, 2021 updated by: Purdue Pharma, Canada

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
257

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Matheson Centre for Mental Health Research & Education, University of Calgary
    • British Columbia
      • Burnaby, British Columbia, Canada, V3N 3N4
        • Adult ADHD Centeres at Pacific Coast Recovery Care
      • Burnaby, British Columbia, Canada, V7T 1C5
        • Medical Arts Health Research Group
    • Ontario
      • Ajax, Ontario, Canada, L1Z 0M1
        • The Kids Clinic Inc.
      • Chatham, Ontario, Canada, N7L 1C1
        • Chatham-Kent Clinical Trials Research Centre
      • Etobicoke, Ontario, Canada, M9V 4C2
        • Pediatric Institute of Excellence
      • Ottawa, Ontario, Canada, K2G1W2
        • Center for Pediatric Excellence
      • Sudbury, Ontario, Canada, P3E 5J1
        • Health Sciences North
      • Windsor, Ontario, Canada, N8X 4X9
        • ADDClinic Windsor
    • Quebec
      • Quebec City, Quebec, Canada, G1G 3Y8
        • Recherche Clinique Sigma inc
      • Québec, Quebec, Canada, G2J 0C4
        • Alpha Recherche Clinique
      • Québec, Quebec, Canada, G3K 2P8
        • Alpha Recherche Clinique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FOQUEST adults
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)
Drug: Methylphenidate Hydrochloride
CR Methylphenidate Hydrochloride given once daily (25 mg, 35 mg, 45 mg, 55 mg, 70 mg, 85 mg or 100 mg)
Other Names:
  • FOQUEST
  • ADHANSIA XR
Active Comparator: VYVANSE adults
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)
Drug: Lisdexamfetamine Dimesylate
Lisdexamfetamine Dimesylate given once daily (10 mg, 20 mg, 30 mg, 40 mg, 50 mg or 60 mg)
Other Names:
  • VYVANSE
Experimental: FOQUEST pediatric
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)
Drug: Methylphenidate Hydrochloride
CR Methylphenidate Hydrochloride given once daily (25 mg, 35 mg, 45 mg, 55 mg, 70 mg, 85 mg or 100 mg)
Other Names:
  • FOQUEST
  • ADHANSIA XR
Active Comparator: VYVANSE pediatric
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)
Drug: Lisdexamfetamine Dimesylate
Lisdexamfetamine Dimesylate given once daily (10 mg, 20 mg, 30 mg, 40 mg, 50 mg or 60 mg)
Other Names:
  • VYVANSE

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in ADHD Rating Scale Total Score
Time Frame: Change from Baseline ADHD Rating Scale Total Score at 4 months
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.
Change from Baseline ADHD Rating Scale Total Score at 4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Non-Inferiority Comparison between Treatments in Change in ADHD Rating Scale Total Score
Time Frame: Change from Baseline ADHD Rating Scale Total Score at 4 Months
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.
Change from Baseline ADHD Rating Scale Total Score at 4 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Purdue Pharma, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 9, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 9, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAN-MA-FOQ-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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