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NCT03422367: JETS
JASPER Early Intervention for Tuberous Sclerosis
NA trial testing JASPER in Tuberous Sclerosis in 64 participants. Status unknown.
15 June 2022
Quick facts
| Lead sponsor | University of California, Los Angeles |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 64 |
| Start date | 24 October 2017 |
| Primary completion | 15 June 2022 |
| Estimated completion | 15 June 2022 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- JASPER
Conditions studied
- Tuberous Sclerosis — all drugs for Tuberous Sclerosis →
Sponsor
University of California, Los Angeles
Who can join
Adults 6 Months to 40 Months, any sex, with Tuberous Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The investigators are running an intervention study for young children with Tuberous Sclerosis Complex (TSC). The study will include free play-based behavioral intervention administered remotely that may improve social and communication skills in children with TSC. Eligible families will have a child in the age range of 12-36 months, with a diagnosis of TSC. Children with TSC below 12 months may be eligible for an early markers study prior to enrollment in the intervention trial. The intervention will focus on teaching caregivers skills to improve the social and communication outcomes of their children. The content of the intervention will be individually tailored to the child's developmental level. The intervention involves 4 on-site assessment visits, and 12 weekly intervention sessions, administered in-person and remotely. The intervention focuses on improving social-communication and play skills.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
A clinical update on tuberous sclerosis complex-associated neuropsychiatric disorders (TAND).
de Vries PJ, Wilde L, de Vries MC, Moavero R, et al · · 2018 · cited 73× · PMID 30117265 · DOI 10.1002/ajmg.c.31637 -
Secular changes in severity of intellectual disability in tuberous sclerosis complex: A reflection of improved identification and treatment of epileptic spasms?
Tye C, Thomas LE, Sampson JR, Lewis J, et al · · 2018 · cited 10× · PMID 29881807 · DOI 10.1002/epi4.12111 -
A telehealth approach to improving clinical trial access for infants with tuberous sclerosis complex.
Hyde C, Pizzano M, McDonald NM, Nelson CA, et al · · 2020 · cited 9× · PMID 31969108 · DOI 10.1186/s11689-019-9302-0 -
Resting state EEG in young children with Tuberous Sclerosis Complex: associations with medications and seizures.
Clements CC, Engelstad AM, Wilkinson CL, Hyde C, et al · · 2025 · cited 3× · PMID 39827117 · DOI 10.1186/s11689-025-09590-z -
Inaugural annual special section of the intellectual and developmental disabilities research centers: developmental cognitive neuroscience and neurodevelopmental disorders.
Jeste SS, Nelson CA. · · 2018 · PMID 30541435 · DOI 10.1186/s11689-018-9258-5
Verify or expand the search:
- PubMed search for NCT03422367
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of JASPER
Trials testing the same drug.
- NCT05638412 — Investigating the Impact of JASPER Behavioral Therapy in Children With Down Syndrome · NA · completed
- NCT04218331 — Boosting Language Outcomes of Minimally Verbal Children With ASD (BLOOM) · NA · active not recruiting
- NCT03883139 — PRISM Intervention Study · NA · active not recruiting
- NCT04283045 — Community-based Adaptive Autism Intervention for Toddlers · NA · completed
- NCT04698538 — TSC Remote Assessment and Intervention · NA · completed
Other recruiting trials for Tuberous Sclerosis
Currently open trials in the same condition.
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- NCT06523582 — Genetic Bases of Neuroendocrine Neoplasms in Mexican Patients · recruiting
- NCT05161494 — Gait in Rare Diseases · active not recruiting
- NCT04463316 — GROWing Up With Rare GENEtic Syndromes · recruiting
- NCT03050268 — Familial Investigations of Childhood Cancer Predisposition · recruiting
Other University of California, Los Angeles trials
Trials by the same sponsor.
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- NCT06701760 — Sodium Lactate in Severe TBI · Phase 2 · not yet recruiting
- NCT04996667 — Effect of iNO in Patients With Submassive and Massive PE · Phase 2 · withdrawn
- NCT05067387 — Evaluation of Oral THC and CBD in Men and Women · Phase 1 · not yet recruiting
- NCT07534696 — Evaluation of Non-Invasive Pelvic Floor Neuromuscular Stimulation for Urinary Incontinence After Prostatectomy · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03422367 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of California, Los Angeles
- Last refreshed: 6 November 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03422367.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing