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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04152629
Recruitment Status : Recruiting
First Posted : November 5, 2019
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma, Canada

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.

Condition or disease Intervention/treatment Phase
Attention Deficit-Hyperactivity Disorder Drug: Methylphenidate Hydrochloride Drug: Lisdexamfetamine Dimesylate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 236 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 19, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020


Arm Intervention/treatment
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 Name: 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 Name: VYVANSE




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04152629


Contacts
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Contact: Ruta Zurkevicius 905-420-3270 Ruta.Zurkevicius@purdue.ca
Contact: Jodan Ratz 905-420-4965 Jodan.Ratzs@purdue.ca

Locations
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Canada, Alberta
Matheson Centre for Mental Health Research & Education, University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Contact: Investigator    403-955-8942      
Canada, British Columbia
Adult ADHD Centeres at Pacific Coast Recovery Care Recruiting
Burnaby, British Columbia, Canada, V3N 3N4
Contact: investigator, PhD    604-526-0088      
Medical Arts Health Research Group Recruiting
Burnaby, British Columbia, Canada, V7T 1C5
Contact: investigator    1-888-736-0667      
Canada, Ontario
The Kids Clinic Inc. Recruiting
Ajax, Ontario, Canada, L1Z 0M1
Contact: Investigator    905-683-1129      
Chatham-Kent Clinical Trials Research Centre Recruiting
Chatham, Ontario, Canada, N7L 1C1
Contact: Investigator    519-397-3791      
Pediatric Institute of Excellence Not yet recruiting
Etobicoke, Ontario, Canada, M9V 4C2
Contact: Investigator    416-748-3939      
Center for Pediatric Excellence Recruiting
Ottawa, Ontario, Canada, K2G1W2
Contact: Investigator, MD    613-726-7436      
Health Sciences North Recruiting
Sudbury, Ontario, Canada, P3E 5J1
Contact: Investigator    705-523-7300      
ADDClinic Windsor Recruiting
Windsor, Ontario, Canada, N8X 4X9
Contact: Investigator    519-252-6400      
Canada, Quebec
Recherche Clinique Sigma Inc Recruiting
Quebec City, Quebec, Canada, G1G 3Y8
Contact: Investigator    418-561-1165      
Alpha recherche clinique Recruiting
Québec, Quebec, Canada, G2J 0C4
Contact: Investigator    418-704-1112      
Alpha recherche clinique Recruiting
Québec, Quebec, Canada, G3K 2P8
Contact: M Investigator    418-847-1112      
Sponsors and Collaborators
Purdue Pharma, Canada
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Responsible Party: Purdue Pharma, Canada
ClinicalTrials.gov Identifier: NCT04152629    
Other Study ID Numbers: CAN-MA-FOQ-001
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Methylphenidate
Lisdexamfetamine Dimesylate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents