Evaluation of Foquest in Adults 65 Years and Older With ADHD

Sponsor
Dar Clinical Research Inc.
Study ID
NCT07710014
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Methylphenidate hydrochloride extended-release capsules — DRUG
    Once-daily oral extended-release methylphenidate capsule with multilayer-release technology (20% immediate-release outer layer, 80% delayed-release core). Starting dose 25 mg daily, titrated weekly over 6 weeks to optimal dose (maximum 100 mg daily) based on efficacy and tolerability. Capsules taken in the morning, swallowed whole or opened and sprinkled on applesauce or yogurt. Available strengths: 25, 35, 45, 55, 70, 85, and 100 mg. Two-week maintenance at optimal dose followed by 2-week follow

Study Details

This study is evaluating the safety and effectiveness of Foquest (multilayer-release methylphenidate), a once-daily extended-release medication for attention-deficit/hyperactivity disorder (ADHD), in adults aged 65 years and older. ADHD can persist into older age and is associated with reduced quality of life and difficulties with executive function. Foquest is currently approved in Canada for the treatment of ADHD in adults up to age 65, but there is very limited research on its use in older adults. People over 65 may respond differently to stimulant medications due to age-related changes in how the body processes drugs, other medical conditions, and increased sensitivity to cardiovascular side effects. This is an open-label study, meaning all participants will know they are receiving the study medication. There is no placebo group. Participants will take Foquest once daily for approximately 10 weeks, including a 6-week dose adjustment period, a 2-week maintenance period, and a 2-week follow-up period. The dose will start at 25 mg daily and may be increased weekly up to a maximum of 100 mg daily based on how well the participant responds and tolerates the medication. The main goal of the study is to measure changes in ADHD symptoms using a clinician-rated scale called the Adult ADHD Investigator Symptom Rating Scale (AISRS). The study will also assess changes in executive function, overall clinical improvement, and cardiovascular safety measures including blood pressure, heart rate, and electrocardiograms (ECGs). Safety will be closely monitored throughout the study, with enhanced cardiovascular monitoring during the first 6 weeks of treatment.

Key Dates

First listed
Jul 17, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Jul 21, 2027
Completion
Jul 21, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Foquest (Multilayer-Release Methylphenidate)
    All participants receive open-label Foquest (multilayer-release methylphenidate hydrochloride) once daily, initiated at 25 mg and titrated weekly over 6 weeks to an optimal dose up to a maximum of 100 mg daily, followed by a 2-week maintenance phase and a 2-week follow-up period.

Primary Outcome Measure

Mean Change in Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score [ Time Frame: Baseline (Week 1) to End of Treatment (Week 8) ]

Central Contacts

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