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NCT03422367: JETS

JASPER Early Intervention for Tuberous Sclerosis

Status unknown NA Last updated 6 November 2020
What this trial tests

NA trial testing JASPER in Tuberous Sclerosis in 64 participants. Status unknown.

Timeline
24 October 2017
Primary endpoint
15 June 2022
15 June 2022

Quick facts

Lead sponsorUniversity of California, Los Angeles
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment64
Start date24 October 2017
Primary completion15 June 2022
Estimated completion15 June 2022
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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:

Other trials of JASPER

Trials testing the same drug.

Other recruiting trials for Tuberous Sclerosis

Currently open trials in the same condition.

Other University of California, Los Angeles trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing