Attention Deficit Hyperactivity DisorderPhase 4NCT07710014
Evaluation of Foquest in Adults 65 Years and Older With ADHD
A Phase 4 study testing Methylphenidate hydrochloride extended-release capsules in people with Attention Deficit Hyperactivity Disorder, run by Dar Clinical Research Inc. at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Methylphenidate hydrochloride extended-release capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 6 Oct 2026to 21 Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Male or female aged 65 years or older at the time of consent.
- Mentally and physically competent to provide informed consent and willing to comply with the study protocol
- Meets DSM-5 criteria for ADHD combined presentation, inattentive presentation, or hyperactive/impulsive presentation based on clinical history
- SRS-5 score of 14 or greater at screening
- AISRS total score of 24 or greater at baseline
- Montreal Cognitive Assessment (MoCA) score of 26 or greater
Who cannot join
- Satisfied with current ADHD treatment
- History of myocardial infarction, arrhythmia, or congenital heart disease
- Mean systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg measured in triplicate at screening despite treatment
- Treated hypertension not stable on medication or with dose changes in the last 30 days
- History of transient ischemic attack or stroke
- Current or lifetime DSM-5 diagnosis of bipolar I or II disorder, cyclothymic disorder, or bipolar disorder not otherwise specified
Show all 18Show fewer
- Clinical history strongly suggestive of undiagnosed bipolar spectrum disorder
- Active suicidal ideation or behavior per C-SSRS at screening
- Current substance use disorder
- History of drug or alcohol abuse in the last 10 years as defined by DSM-5 criteria for substance use disorder (moderate or severe)
- True allergy to methylphenidate, history of serious adverse reactions to methylphenidate, or known non-response to methylphenidate
- History of seizure disorder other than a single childhood febrile seizure before age 3
- History of glaucoma, hyperthyroidism, thyrotoxicosis, advanced arteriosclerosis, or severe renal insufficiency (eGFR less than 30 mL/min/1.73 m²)
- Use of a monoamine oxidase inhibitor currently or within the past 14 days
- Abnormal baseline ECG including left ventricular hypertrophy or QTc greater than 450 ms (males) or greater than 470 ms (females)
- History of heart failure, unexplained dyspnea on exertion, or newly identified murmur
- MoCA score less than 26 or evidence of cognitive impairment
- Currently considered a suicide risk in the opinion of the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
DAR Clinical Research Inc.
Ottawa, Ontario, K2J 3Z6
About this study
Official title: Evaluation of Foquest® (Multilayer-Release Methylphenidate) in Adults ≥ 65 Years With ADHD: An Open-Label, Investigator-Initiated Trial
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.
Read more
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.
Read the detailed description
This is a prospective, open-label, within-subject (pre-post), investigator-initiated Phase IV trial evaluating the safety and efficacy of Foquest (multilayer-release methylphenidate hydrochloride; MLR-MPH) in adults aged 65 years and older with a DSM-5 diagnosis of ADHD.
Background: Foquest is a once-daily oral stimulant consisting of a 20% immediate-release outer layer and an 80% delayed-release core, with onset of effect within approximately 1 hour and duration of up to 16 hours. It is approved by Health Canada for ADHD in adults up to age 65. The product monograph acknowledges that data are lacking for individuals above this age. Pharmacoepidemiologic evidence (Tadrous et al., 2021) suggests a transient increase in cardiovascular risk during the first 30 days of stimulant initiation in adults aged 66 and older, underscoring the need for careful cardiac screening and monitoring in this population.
Study Design: Each participant will be involved for approximately 10 weeks, comprising a 6-week dose titration phase, a 2-week maintenance phase, and a 2-week follow-up period. Participants will attend 5 in-person visits and 4 phone visits. Foquest will be initiated at 25 mg daily (or an investigator-selected dose based on prior medication history) and titrated weekly to a maximum of 100 mg daily based on efficacy and tolerability.
Cardiovascular Safety Monitoring: Enhanced cardiovascular monitoring is incorporated based on published evidence of early cardiovascular risk with stimulant initiation in older adults. Blood pressure and heart rate are measured in triplicate at screening and assessed at all in-person visits. Twelve-lead ECGs are performed at screening, baseline, Week 3, Week 5, and end of treatment (Week 8). Predefined criteria for treatment interruption include sustained resting heart rate greater than 100 bpm, systolic blood pressure greater than 180 mmHg, or diastolic blood pressure greater than 110 mmHg. Immediate discontinuation criteria include blood pressure at or above 180/120 mmHg, new arrhythmia, or symptoms suggestive of acute cardiovascular or cerebrovascular events.
Primary Endpoint: Mean change from baseline (Week 1) to end of treatment (Week 8) in AISRS total score, analyzed using a paired t-test in the modified intention-to-treat population.
Secondary Endpoints: Change from baseline to Week 8 in ASRS-5 total score, CGI-S score, BRIEF-A Global Executive Composite T-score, and distribution of CGI-I scores at Week 8. Cardiovascular parameters (systolic and diastolic blood pressure, heart rate, QTcF interval) and adverse events will be analyzed as safety endpoints.
Sample Size: 36 participants are planned, allowing for up to 15% attrition to ensure 30 completers, providing 80% power to detect a within-subject effect size of Cohen's d of 0.53 or greater.
This study addresses a critical evidence gap regarding the pharmacological treatment of ADHD in older adults and aims to inform evidence-based prescribing decisions for this underserved population.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Methylphenidate hydrochloride extended-release capsules
- Keywords
- ADHD, Methylphenidate, Foquest, Geriatric, Extended-Release Stimulant, Attention Deficit Disorder
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylphenidate hydrochloride extended-release capsulesDrug
Also called Foquest, MLR-MPH
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 group | Role | What they receive |
|---|---|---|
| Foquest (Multilayer-Release Methylphenidate) | Experimental | 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. Receives: Drug: Methylphenidate hydrochloride extended-release capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score
Mean change from baseline (Week 1) to end of treatment (Week 8) in AISRS total score. The AISRS is an 18-item clinician-administered scale aligned with DSM criteria for ADHD, with each item rated 0-3 (total score range 0-54). Higher scores indicate greater symptom severity. Analysis uses a paired t-test in the modified intention-to-treat population.
Measured: Baseline (Week 1) to End of Treatment (Week 8)
Secondary outcomes (7)
Mean Change in ASRS-5 Total Score
Mean change from baseline to Week 8 in the Adult ADHD Self-Report Scale version 1.1 (ASRS-5) total score. The ASRS-5 is an 18-item self-report questionnaire with Part A (Inattention) and Part B (Hyperactivity/Impulsivity), items rated 0 (Never) to 4 (Very Often). Analyzed using paired t-test and repeated-measures ANOVA across post-baseline timepoints (Weeks 3, 5, and 8).
Measured: Baseline (Week 1) to Week 8, with interim assessments at Weeks 3 and 5
Mean Change in Clinical Global Impression - Severity (CGI-S) Score
Mean change from baseline to Week 8 in CGI-S score. The CGI-S is a 7-point clinician-rated scale of overall illness severity (1 = Normal, not at all ill; 7 = Among the most extremely ill patients). A responder analysis will report the proportion of participants achieving CGI-S score of 3 or less (mildly ill or better) at Week 8.
Measured: Baseline (Week 1) to Week 8
Clinical Global Impression - Improvement (CGI-I) Responder Rate
Distribution of CGI-I scores at Week 8. The CGI-I is a 7-point clinician-rated scale evaluating change from baseline (1 = Very much improved; 7 = Very much worse). The clinical responder rate is defined as the proportion of participants rated as much improved or very much improved (CGI-I score of 2 or less) at Week 8, reported with 95% exact binomial confidence intervals.
Measured: Week 8 (End of Treatment)
Mean Change in BRIEF-A Global Executive Composite (GEC) T-Score
Mean change from baseline to Week 8 in the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Global Executive Composite T-score. The BRIEF-A is a 75-item self-report measure of executive functioning in adults aged 18-90, producing norm-referenced T-scores. Higher scores indicate greater executive dysfunction. Individual index scores (Behavioral Regulation Index, Metacognition Index) will also be analyzed.
Measured: Baseline (Week 1) to Week 8
Change in Systolic Blood Pressure
Mean change from baseline to Week 8 in resting systolic blood pressure (mmHg). Assessed at in-person visits at Weeks 0, 3, 5, and 8. Outlier criteria: systolic BP greater than 140 mmHg or increase greater than 20 mmHg from baseline.
Measured: Baseline (Week 1) to Week 8, with interim assessments at Weeks 3 and 5
Incidence of Treatment-Emergent Adverse Events
Incidence of treatment-emergent adverse events (TEAEs) summarized by system organ class and preferred term using MedDRA coding. TEAEs tabulated by severity (mild, moderate, severe) and relationship to study medication. Serious adverse events, adverse events leading to dose modification, and adverse events leading to discontinuation reported separately.
Measured: From first dose of study medication to 14 days after study completion (approximately 10 weeks)
Columbia-Suicide Severity Rating Scale (C-SSRS) Changes
C-SSRS data summarized at each visit using frequency and percentage of participants in each suicidal ideation severity category (0-5), shift tables showing treatment-emergent changes from baseline (new onset or worsening of suicidal ideation category), and incidence of any suicidal behavior events.
Measured: Baseline (Week 1) through End of Study/Follow-Up (Week 10), assessed at every study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start6 Oct 2026
- Primary completion21 Jul 2027 (estimated)
- Study completion21 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive the same drug; there is no randomization to different arms. This is a within-subject (pre-post) design.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dar Clinical Research Inc.
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Judy van Stralen, MD, FRCPC, Principal investigator, JPM van Stralen Medicine Professional Corporation / DAR Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710014
- Sponsor's protocol ID
- MLR-MPH-OLDERADULT-01
- Status last verified
- Oct 2026
- First submitted
- 8 Jul 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wakamatsu A, Nomura S, Tate Y, Shimizu S, Harada Y. Effects of methylphenidate hydrochloride on the cardiovascular system in vivo and in vitro: a safety pharmacology study. J Pharmacol Toxicol Methods. 2009 May-Jun;59(3):128-34. doi: 10.1016/j.vascn.2009.01.003. Epub 2009 Mar 9.
PubMed 19281853Tadrous M, Shakeri A, Chu C, Watt J, Mamdani MM, Juurlink DN, Gomes T. Assessment of Stimulant Use and Cardiovascular Event Risks Among Older Adults. JAMA Netw Open. 2021 Oct 1;4(10):e2130795. doi: 10.1001/jamanetworkopen.2021.30795.
PubMed 34694389Parasrampuria DA, Schoedel KA, Schuller R, Silber SA, Ciccone PE, Gu J, Sellers EM. Do formulation differences alter abuse liability of methylphenidate? A placebo-controlled, randomized, double-blind, crossover study in recreational drug users. J Clin Psychopharmacol. 2007 Oct;27(5):459-67. doi: 10.1097/jcp.0b013e3181515205.
PubMed 17873677Michielsen M, Kleef D, Bijlenga D, Zwennes C, Dijkhuizen K, Smulders J, Hazewinkel A, Beekman ATF, Kooij JJS. Response and Side Effects Using Stimulant Medication in Older Adults With ADHD: An Observational Archive Study. J Atten Disord. 2021 Oct;25(12):1712-1719. doi: 10.1177/1087054720925884. Epub 2020 Jun 8.
PubMed 32508213Godfrey J. Safety of therapeutic methylphenidate in adults: a systematic review of the evidence. J Psychopharmacol. 2009 Mar;23(2):194-205. doi: 10.1177/0269881108089809. Epub 2008 May 30.
PubMed 18515459Garcia-Argibay M, Burkner PC, Lichtenstein P, Zhang L, D'Onofrio BM, Andell P, Chang Z, Cortese S, Larsson H. Methylphenidate and Short-Term Cardiovascular Risk. JAMA Netw Open. 2024 Mar 4;7(3):e241349. doi: 10.1001/jamanetworkopen.2024.1349.
PubMed 38446477Adler LA, Orman C, Starr HL, Silber S, Palumbo J, Cooper K, Berwaerts J, Harrison DD. Long-term safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder: an open-label, dose-titration, 1-year study. J Clin Psychopharmacol. 2011 Feb;31(1):108-14. doi: 10.1097/JCP.0b013e318203ea0a.
PubMed 21192153
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Foquest® (Multilayer-Release Methylphenidate) in Adults ≥ 65 Years With ADHD: An Open-Label, Investigator-Initiated Trial
- ClinicalTrials.gov ID
- NCT07710014
- Acronym / sponsor ID
- MLR-MPH-OLDERADULT-01
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Methylphenidate, Foquest, Geriatric, Extended-Release Stimulant, Attention Deficit Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Dar Clinical Research Inc.Research network
- Study start
- 6 Oct 2026 (actual)
- Primary completion
- 21 Jul 2027 (estimated)
- Study completion
- 21 Jul 2027 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, open-label, within-subject (pre-post), investigator-initiated Phase IV trial evaluating the safety and efficacy of Foquest (multilayer-release methylphenidate hydrochloride; MLR-MPH) in adults aged 65 years and older with a DSM-5 diagnosis of ADHD.
Background: Foquest is a once-daily oral stimulant consisting of a 20% immediate-release outer layer and an 80% delayed-release core, with onset of effect within approximately 1 hour and duration of up to 16 hours. It is approved by Health Canada for ADHD in adults up to age 65. The product monograph acknowledges that data are lacking for individuals above this age. Pharmacoepidemiologic evidence (Tadrous et al., 2021) suggests a transient increase in cardiovascular risk during the first 30 days of stimulant initiation in adults aged 66 and older, underscoring the need for careful cardiac screening and monitoring in this population.
Study Design: Each participant will be involved for approximately 10 weeks, comprising a 6-week dose titration phase, a 2-week maintenance phase, and a 2-week follow-up period. Participants will attend 5 in-person visits and 4 phone visits. Foquest will be initiated at 25 mg daily (or an investigator-selected dose based on prior medication history) and titrated weekly to a maximum of 100 mg daily based on efficacy and tolerability.
Cardiovascular Safety Monitoring: Enhanced cardiovascular monitoring is incorporated based on published evidence of early cardiovascular risk with stimulant initiation in older adults. Blood pressure and heart rate are measured in triplicate at screening and assessed at all in-person visits. Twelve-lead ECGs are performed at screening, baseline, Week 3, Week 5, and end of treatment (Week 8). Predefined criteria for treatment interruption include sustained resting heart rate greater than 100 bpm, systolic blood pressure greater than 180 mmHg, or diastolic blood pressure greater than 110 mmHg. Immediate discontinuation criteria include blood pressure at or above 180/120 mmHg, new arrhythmia, or symptoms suggestive of acute cardiovascular or cerebrovascular events.
Primary Endpoint: Mean change from baseline (Week 1) to end of treatment (Week 8) in AISRS total score, analyzed using a paired t-test in the modified intention-to-treat population.
Secondary Endpoints: Change from baseline to Week 8 in ASRS-5 total score, CGI-S score, BRIEF-A Global Executive Composite T-score, and distribution of CGI-I scores at Week 8. Cardiovascular parameters (systolic and diastolic blood pressure, heart rate, QTcF interval) and adverse events will be analyzed as safety endpoints.
Sample Size: 36 participants are planned, allowing for up to 15% attrition to ensure 30 completers, providing 80% power to detect a within-subject effect size of Cohen's d of 0.53 or greater.
This study addresses a critical evidence gap regarding the pharmacological treatment of ADHD in older adults and aims to inform evidence-based prescribing decisions for this underserved population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive the same drug; there is no randomization to different arms. This is a within-subject (pre-post) design.
| Arm | Type | Receives |
|---|---|---|
| Foquest (Multilayer-Release Methylphenidate) | Experimental | Drug: Methylphenidate hydrochloride extended-release capsulesAll 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Male or female aged 65 years or older at the time of consent.
- Mentally and physically competent to provide informed consent and willing to comply with the study protocol
- Meets DSM-5 criteria for ADHD combined presentation, inattentive presentation, or hyperactive/impulsive presentation based on clinical history
- SRS-5 score of 14 or greater at screening
- AISRS total score of 24 or greater at baseline
Key exclusion criteria (18 listed)
- Satisfied with current ADHD treatment
- History of myocardial infarction, arrhythmia, or congenital heart disease
- Mean systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg measured in triplicate at screening despite treatment
- Treated hypertension not stable on medication or with dose changes in the last 30 days
- History of transient ischemic attack or stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylphenidate hydrochloride extended-release capsulesAlso: Foquest, MLR-MPHOnce-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 | Drug | Foquest (Multilayer-Release Methylphenidate) |
Primary outcome
Mean Change in Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score
Time frame: Baseline (Week 1) to End of Treatment (Week 8)
Mean change from baseline (Week 1) to end of treatment (Week 8) in AISRS total score. The AISRS is an 18-item clinician-administered scale aligned with DSM criteria for ADHD, with each item rated 0-3 (total score range 0-54). Higher scores indicate greater symptom severity. Analysis uses a paired t-test in the modified intention-to-treat population.
7 secondary outcomes
Mean Change in ASRS-5 Total Score
Time frame: Baseline (Week 1) to Week 8, with interim assessments at Weeks 3 and 5
Mean Change in Clinical Global Impression - Severity (CGI-S) Score
Time frame: Baseline (Week 1) to Week 8
Clinical Global Impression - Improvement (CGI-I) Responder Rate
Time frame: Week 8 (End of Treatment)
Mean Change in BRIEF-A Global Executive Composite (GEC) T-Score
Time frame: Baseline (Week 1) to Week 8
Change in Systolic Blood Pressure
Time frame: Baseline (Week 1) to Week 8, with interim assessments at Weeks 3 and 5
Incidence of Treatment-Emergent Adverse Events
Time frame: From first dose of study medication to 14 days after study completion (approximately 10 weeks)
Columbia-Suicide Severity Rating Scale (C-SSRS) Changes
Time frame: Baseline (Week 1) through End of Study/Follow-Up (Week 10), assessed at every study visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 19281853Wakamatsu A, Nomura S, Tate Y, Shimizu S, Harada Y. Effects of methylphenidate hydrochloride on the cardiovascular system in vivo and in vitro: a safety pharmacology study. J Pharmacol Toxicol Methods. 2009 May-Jun;59(3):128-34. doi: 10.1016/j.vascn.2009.01.003. Epub 2009 Mar 9.
- Background: PubMed 34694389Tadrous M, Shakeri A, Chu C, Watt J, Mamdani MM, Juurlink DN, Gomes T. Assessment of Stimulant Use and Cardiovascular Event Risks Among Older Adults. JAMA Netw Open. 2021 Oct 1;4(10):e2130795. doi: 10.1001/jamanetworkopen.2021.30795.
- Background: PubMed 17873677Parasrampuria DA, Schoedel KA, Schuller R, Silber SA, Ciccone PE, Gu J, Sellers EM. Do formulation differences alter abuse liability of methylphenidate? A placebo-controlled, randomized, double-blind, crossover study in recreational drug users. J Clin Psychopharmacol. 2007 Oct;27(5):459-67. doi: 10.1097/jcp.0b013e3181515205.
- Background: PubMed 32508213Michielsen M, Kleef D, Bijlenga D, Zwennes C, Dijkhuizen K, Smulders J, Hazewinkel A, Beekman ATF, Kooij JJS. Response and Side Effects Using Stimulant Medication in Older Adults With ADHD: An Observational Archive Study. J Atten Disord. 2021 Oct;25(12):1712-1719. doi: 10.1177/1087054720925884. Epub 2020 Jun 8.
- Background: PubMed 18515459Godfrey J. Safety of therapeutic methylphenidate in adults: a systematic review of the evidence. J Psychopharmacol. 2009 Mar;23(2):194-205. doi: 10.1177/0269881108089809. Epub 2008 May 30.
- Background: PubMed 38446477Garcia-Argibay M, Burkner PC, Lichtenstein P, Zhang L, D'Onofrio BM, Andell P, Chang Z, Cortese S, Larsson H. Methylphenidate and Short-Term Cardiovascular Risk. JAMA Netw Open. 2024 Mar 4;7(3):e241349. doi: 10.1001/jamanetworkopen.2024.1349.
- Background: PubMed 21192153Adler LA, Orman C, Starr HL, Silber S, Palumbo J, Cooper K, Berwaerts J, Harrison DD. Long-term safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder: an open-label, dose-titration, 1-year study. J Clin Psychopharmacol. 2011 Feb;31(1):108-14. doi: 10.1097/JCP.0b013e318203ea0a.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Judy van Stralen, MD, FRCPC principal investigator
JPM van Stralen Medicine Professional Corporation / DAR Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylphenidate hydrochloride extended-release capsules in people with Attention Deficit Hyperactivity Disorder, run by Dar Clinical Research Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Judy van Stralen, M.D, FRCPC (613-726-7355 ext. 101, judy@cfpe.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07710014, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.