A Phase 1 interventional study of Methylphenidate Oral Solution in Intellectual Disability, Fragile X Syndrome and Down Syndrome, sponsored by University of California, Davis. Enrolling by invitation at 3 sites in United States. Open to participants aged 6 Years to 24 Years. Per ClinicalTrials.gov, last updated 2025-12-15.
Sponsored by University of California, Davis · Phase 1, Interventional, and Other
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Among 121 studies in Intellectual Disability with a site in United States — 31 open to participants now, 39 under way, 3 of them phase 3. Intellectual Disability · United States.
Among the 121 studies in Intellectual Disability with a site in United States, this one is the 27th largest by planned enrollment of the 81 interventional ones that give a count, is one of 13 that started in 2023, is one of 7 in phase 1, reaches primary completion later than 10 of the 37 other live ones, and was the 79th registered.
388 studies on the registry are indexed under Intellectual Disability; 106 are open to participants now.
Browse Intellectual Disability studies →31 of the 121 studies in Intellectual Disability with a site in United States are open now. Recruiting first, the newest first:
Children's Mercy Hospital Kansas City · Sites in United States
Ages 8–12
Children's Hospital Los Angeles · Sites in United States
Ages 10–17
University Hospitals Cleveland Medical Center · Sites in United States
Ages 18–89
National Institutes of Health Clinical Center (CC) · Sites in United States
Ages 8–30 · Healthy volunteers
Joel E. Ringdahl · Sites in United States
Ages 2–90
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 69 Intellectual Disability studies recruiting now, 27 (39%) set no upper age limit and 33 (48%) stop at 75 or younger; 49 take children under 18; 13 take healthy volunteers.
This study: 6 Years to 24 Years · all sexes · no healthy volunteers.
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121 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 12 · Phase 2 9 · Phase 3 9 · Phase 4 5
First in 1987; this study’s year is marked. 13 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 68 is above the median of 59 across 249 interventional studies indexed under Intellectual Disability.
Median enrollment 40 across the 81 interventional studies, 176 across the 37 observational. Of the 75 that completed or were terminated, 18 (24%) have results posted.
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10 of 121 have an industry lead sponsor. The 10 most frequent:
University of California, Davis is the lead sponsor of 810 studies on the registry; 142 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.
University of California, Davis has 4 studies filed under Intellectual Disability — fewer than ten, so there is no comparison to draw.
10 of the studies in Intellectual Disability with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02914951Yale UniversityCognitive-Behavioral Therapy for Irritability in Children With Autism Spectrum Disorder and Intellectual Disability | 2026-12 |
| NCT06829264University of California, DavisTesting an Evidence-Based Supported Employment Model in Autistic Young Adults | 2026-12-01 |
| NCT00305305University of California, San FranciscoBrain Development Research Program | 2027-01 |
| NCT03718936Icahn School of Medicine at Mount SinaiADNP Syndrome: The Seaver Autism Center for Research and Treatment is Characterizing ADNP-related Neurodevelopmental Disorders Using Genetic, Medical, and Neuropsychological Measures. | 2027-03 |
| NCT06065527Northwell HealthFuture Planning and Well-Being for Individuals With Intellectual Disabilities and Family Caregivers | 2027-06-30 |
Add all 10 to your calendar (.ics) → With an account.
Among the 121 studies in Intellectual Disability with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study is a randomized, double-blind, placebo-controlled, crossover trial of extended-release liquid methylphenidate (XRMPH) to evaluate the sensitivity of the NIH Toolbox Cognition Battery (NIHTB-CB) to changes in cognition in children and adolescents ages 6 to 17 with intellectual disability (D) and comorbid Attention Deficit Hyperactivity Disorder (ADHD). The sample will include 68 males or females (expected male: female ratio of 1.8:1 with ID and ADHD as determined by structured diagnostic interview and Conners 3 scores. Additional inclusion criteria will include Full Scale IQ above 50 and mental age greater than or equal to 3 years. In addition, participants must be able to complete NIHTB-CB testing and provide valid scores at baseline. After baseline testing, participants will then be randomized to drug or placebo in a 1:1 ratio (N=34 per group) at the end of the baseline visit. XRMPH in oral suspension supplied as Quillivant XR in 5 mg/ml (Tris Pharma, Monmouth Junction, NJ) will be the active treatment. The XRMPH or matching placebo will be started at a dose of 0.3 mg/kg/day and individually titrated over two weeks. Phone calls at the end of weeks 1, 2, and 3 will be used to collect adverse event and response data. If there is no evidence of side effects and ongoing symptoms of ADHD, the dose will be increased to 0.5 mg/kg/day at one week and 0.7 mg/kg/day at 2 weeks (maximum dose of 60 mg per day consistent with FDA labeled use in youth). The Clinical Global Impression (CGI) will be used as a guide to define optimal dose. If side effects occur the dose will be reduced to the dose level at which there were no side effects. Final optimal dose will be established by the end of week 3 and this will be maintained for 2 weeks until 5 weeks post randomization, at which time the follow-up parent and teacher Conners scales, NIHTB-CB, Go/No-Go, and PedsQL will be completed. Participants will have a washout period of 1 week, will then complete re-assessment at the second baseline, and then will cross over to the other treatment (Quillivant to placebo; placebo to Quillivant), also in a double-blind fashion. In the second treatment arm, patients will have the same titration, monitoring and treatment periods as in the first arm, again followed by repeated assessments at the conclusion of 5 weeks. The accrual of participants and number of visits is shown in the Timeline per 6-month period.
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Exclusion Criteria:
Drug: Methylphenidate Oral Solution
Drug: Methylphenidate Oral Solution
The XRMPH or matching placebo will be started at a dose of 0.3 mg/kg/day and individually titrated over two weeks. Phone calls at the end of weeks 1, 2, and 3 will be used to collect adverse event and response data. If there is no evidence of side effects and ongoing symptoms of ADHD, the dose will be increased to 0.5 mg/kg/day at one week and 0.7 mg/kg/day at 2 weeks (maximum dose of 60 mg per day consistent with FDA labeled use in youth).
Composite score of NIHTB-CB Flanker, Dimensional Change Card Sort, List Sorting and Speeded Matching tests.
The composite score is calculated as the average of the non-age adjusted standard scores of each of these four tests. These standard scores have a mean of 100 and SD of 15. A minimum of 3/4 valid scores is required to calculate an average composite score.
Time frame: 11 weeks
Conners 3 ADHD Rating Scale Inattention Scale
Time frame: 11 weeks
Conners 3 ADHD Rating Scale Hyperactivity/Impulsivity Scale
Time frame: 11 weeks
Started Feb 2023 (actual). Primary completion is estimated for Sep 2026, 43 months after the start.
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Studies of the drug tested here: Methylphenidate
University of California, Davis →