A Phase 4 interventional study of Methylphenidate Hydrochloride and Lisdexamfetamine Dimesylate in Attention Deficit-Hyperactivity Disorder, sponsored by Purdue Pharma, Canada. Completed at 12 sites in Canada. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2021-09-16.
Sponsored by Purdue Pharma, Canada · Phase 4, Interventional, and Treatment
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.
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.
729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.
This study's enrollment of 257 is above the median of 80 across 583 interventional studies indexed under Hyperkinesis.
Browse Hyperkinesis studies →Purdue Pharma, Canada is the lead sponsor of 5 studies on the registry; none are open to participants now.
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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:
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
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
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
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
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
Lisdexamfetamine Dimesylate given once daily (10 mg, 20 mg, 30 mg, 40 mg, 50 mg or 60 mg)
Also known as: VYVANSE
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.
Time frame: Change from Baseline ADHD Rating Scale Total Score at 4 months
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.
Time frame: Change from Baseline ADHD Rating Scale Total Score at 4 Months
Plan to share: No
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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Purdue Pharma, Canada