Real World Evidence of the Efficacy and Safety of FOQUEST

NCT04152629 | Completed Phase 4

• 1 other identifier: CAN-MA-FOQ-001
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 12

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.

Conditions

Attention Deficit-Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from Baseline ADHD Rating Scale Total Score at 4 months

Secondary Outcomes (1)

• Non-Inferiority Comparison between Treatments in Change in ADHD Rating Scale Total Score

  Change from Baseline ADHD Rating Scale Total Score at 4 Months

Study Arms (4)

FOQUEST adults

EXPERIMENTAL

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

VYVANSE adults

ACTIVE COMPARATOR

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

FOQUEST pediatric

EXPERIMENTAL

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

VYVANSE pediatric

ACTIVE COMPARATOR

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

Interventions

Methylphenidate Hydrochloride DRUG

CR Methylphenidate Hydrochloride given once daily (25 mg, 35 mg, 45 mg, 55 mg, 70 mg, 85 mg or 100 mg)

Also known as: FOQUEST, ADHANSIA XR

FOQUEST adults; FOQUEST pediatric

Lisdexamfetamine Dimesylate DRUG

Lisdexamfetamine Dimesylate given once daily (10 mg, 20 mg, 30 mg, 40 mg, 50 mg or 60 mg)

Also known as: VYVANSE

VYVANSE adults; VYVANSE pediatric

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Purdue Pharma, Canada: lead

Study Sites (12)

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

Calgary, Alberta, T2N 4Z6, Canada

Location

Adult ADHD Centeres at Pacific Coast Recovery Care

Burnaby, British Columbia, V3N 3N4, Canada

Location

Medical Arts Health Research Group

Burnaby, British Columbia, V7T 1C5, Canada

Location

The Kids Clinic Inc.

Ajax, Ontario, L1Z 0M1, Canada

Location

Chatham-Kent Clinical Trials Research Centre

Chatham, Ontario, N7L 1C1, Canada

Location

Pediatric Institute of Excellence

Etobicoke, Ontario, M9V 4C2, Canada

Location

Health Sciences North

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Center for Pediatric Excellence

Ottawa, Ontario, K2G1W2, Canada

Location

ADDClinic Windsor

Windsor, Ontario, N8X 4X9, Canada

Location

Recherche Clinique Sigma Inc

Québec, Quebec, G1G 3Y8, Canada

Location

Alpha recherche clinique

Québec, Quebec, G2J 0C4, Canada

Location

Alpha recherche clinique

Québec, Quebec, G3K 2P8, Canada

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate; Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 5, 2019
• Study Start: September 19, 2019
• Primary Completion: July 9, 2021
• Study Completion: July 9, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (12)