NCT04152629

Real World Evidence of the Efficacy and Safety of FOQUEST

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 257 (actual)
• Sponsor: Purdue Pharma, Canada · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Attention Deficit-Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Methylphenidate Hydrochloride	CR Methylphenidate Hydrochloride given once daily (25 mg, 35 mg, 45 mg, 55 mg, 70 mg, 85 mg or 100 mg)
DRUG	Lisdexamfetamine Dimesylate	Lisdexamfetamine Dimesylate given once daily (10 mg, 20 mg, 30 mg, 40 mg, 50 mg or 60 mg)

Timeline

• Start date: 2019-09-19
• Primary completion: 2021-07-09
• Completion: 2021-07-09
• First posted: 2019-11-05
• Last updated: 2021-09-16

Locations

12 sites across 1 country: Canada