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RecruitingNCT06967727Updated Aug 17, 2025

Registry and Natural History of Epilepsy-Dyskinesia Syndromes

An observational study in Epilepsy-Dyskinesia, Epilepsy and Dyskinesia, sponsored by Boston Children's Hospital. Recruiting at 1 site in United States. Open to participants aged 0 Years to 30 Years. Per ClinicalTrials.gov, last updated 2025-08-17.

Sponsored by Boston Children's Hospital · Observational

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
700
Ages
0 Years to 30 Years
Sex
All
01

Study summary

The Registry and Natural History of Epilepsy-Dyskinesia Syndromes is focused on gathering longitudinal clinical data as well as biological samples (blood, urine, and/or skin/tissue) from male and female patients, of all ages, who have a genetic diagnosis of epilepsy-dyskinesia syndromes. Through prospective review and molecular data analysis, the study aims to identify patterns and correlations between movement and seizure disorders, uncovering genotype-phenotype relationships. The initiative's goals are to enhance understanding of epilepsy-dyskinesia syndromes, inform precision medicine approaches, and foster international collaboration.

Read the detailed description

Movement disorders in childhood encompass a range of neurologic syndromes that are characterized by abnormalities of tone, posture, the initiation or control of voluntary movements, or unwanted involuntary movements. They are conventionally divided into hyperkinetic (dystonia, chorea, myoclonus, stereotypies, tics, and tremors) and hypokinetic (parkinsonism). Children often present with mixed movement disorders rather than pure syndromes and in a complex form, meaning associated comorbidities such as developmental delay, microcephaly, or epilepsy (Pearson and Pons 2019; Pérez-Dueñas et al. 2022).

Neurological disorders characterized by both non-epileptic abnormal movements and epileptic seizures are termed "Epilepsy-Dyskinesia Syndromes" (Papandreou et al. 2020). These conditions encompass a spectrum of disorders with diverse etiologies. Their origins can be categorized into two main groups: acquired and genetic. Acquired causes include conditions such as cerebral palsy, autoimmune encephalitis, post-infectious syndromes, and post-stroke complications. Conversely, genetic factors play a significant role in the development of these syndromes, contributing to their varied clinical presentations and underlying pathophysiology. By recognizing and categorizing these disorders based on their etiology, clinicians and researchers can better understand their diverse manifestations and tailor treatment strategies accordingly.

More than 100 genes have been associated with Epilepsy-Dyskinesia Syndromes, showcasing an increasing appreciation of the overlap of genetic early-onset epilepsies and hyperkinetic movement disorders with genes involved in key cellular functions for brain development; however, this association remains understudied (Spagnoli et al. 2021; Papandreou et al. 2020; de Gusmão et al. 2021). To add to this, with the increasing capacity and availability of genetic diagnostics, two important concepts have emerged: 1) Genetic heterogeneity - one phenotype can be caused by variants in multiple different genes; and 2) Phenotypic pleiotropy - variants in one gene cause several different movement disorders phenotypes (Gannamani et al. 2021).

Collaborative research into these syndromes is critical to building a better understanding of these concepts to advance in precision medicine for these syndromes, targeting molecular structures implicated in the pathogenesis of both movement disorders and epilepsy. Challenges for many rare disease research programs included a geographically dispersed and small patient population or lack of harmonization of existing research protocols.

The creation of prospective registry and natural history study aims to gather comprehensive information on various aspects of these conditions, including clinical features, progression, developmental history, level of functionality and response to treatment. This study will also compile data on other disease aspects, such as age of onset for both movement disorders and seizures, genetic variants, and concurrent neurological conditions.

General aims are to:

  1. Determine the natural history and genotype-phenotype correlations of disease-causing variants of epilepsy-dyskinesia syndromes.
  2. Establish a biobank for patients with a pathogenic or likely pathogenic variant in one of the genes of interest and the presence of a childhood-onset movement disorder, enabling quantitative profiling of biochemical biomarkers.
  3. Facilitate an early diagnosis, enable counseling with anticipatory guidance of affected families and help define clinically meaningful endpoints for future interventional traits.

Specific aims include:

1. To comprehensively understand the spectrum and association of movement and seizure disorders on both clinical and molecular levels.

1a. Assess the molecular mechanisms underlying the co-occurrence of movement and seizure disorders to elucidate common pathways and potential targets for intervention.

1b. Characterize the clinical manifestations and phenotypic spectrum of individuals presenting with movement and seizure disorders, aiming to delineate standard clinical features and diagnostic challenges.

1c. Investigate shared genetic and molecular mechanisms underlying the co-occurrence of movement and seizure disorders, focusing on identifying common genetic variants and pathways implicated in both conditions.

2. Investigate the efficacy of symptomatic treatments in addressing both seizure and movement disorders, aiming to identify shared therapeutic strategies.

3. To assess the impact of movement disorders on health-related quality of life, specifically within the context of genetic epilepsies.

3a. Quantify the effects of movement disorders on various health-related quality of life domains in individuals with genetic epilepsies, including physical, emotional, and social well-being.

3b. Identify factors contributing to the variability in quality-of-life outcomes among individuals with genetic epilepsies affected by movement disorders, such as disease severity and treatment response.

02

Conditions studied

  • Epilepsy-Dyskinesia
  • Epilepsy
  • Dyskinesia
  • EDS
  • Epilepsy-Dyskinesia Syndomes
  • Epilepsy in Children
  • Dyskinesias
  • Movement Disorders in Children
  • Neurologic Disorder
  • Chorea
  • Myoclonus
  • Ataxia
  • Dystonia Disorder
  • Movement Disorders

Keywords

  • epilepsy
  • Epilepsy-Dyskinesia
  • Epilepsy-Dyskinesia Syndrome
  • Dyskinesia
  • movement disorders
  • epileptic encephalopathy
  • neurogenetics
  • PRRT2
  • ATP1A3
  • GNAO1
  • MECP2
  • CACNA1A
  • CDKL5
  • FOXG1
  • SCN1A
  • SCN8A
  • SLC2A1
  • STXBP1
  • UBA5
  • ADCY5
03

In context

Epilepsy

1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.

This study's planned enrollment of 700 is above the median of 112 across 540 observational studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
0 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This study will enroll individuals diagnosed with a movement disorder due to pathogenic or likely pathogenic variants in the genes listed below.

AARS2, ADCY5, ALG13, AP3B2, AP4B1, AP4E1, AP4M1, AP4S1, ARX, ATP1A3, CACNA1A, CACNA1E, CACNA2D2, CDKL5, CSTB, DARS2, DLAT, DLD, DNM1, EARS2, EPG5, EPM2A, FARS2, FOXG1, FRRS1L, GABRA1, GABRA2, GABRB2, GABRB3, GABRG2, GNAO1, GRIA2, GRIA4, GRIN1, GRIN2A, GRIN2B, GRIN2D, HARS2, HNRNPU, HTT, IQSEC2, IRF2BPL, KCNA2, KCNB1, KCNC1, KCNMA1, KCNQ2, KCNQ3, KCNT1, LARS2, MECP2, MEF2C, MTND5, MTTK, MTTL1, NARS2, NHLRC1, PCDH12, PCDH19, PDE10A, PDE2, PDHA1, PDHB, PDHX, PDK3, PDP1, PIGA, PIGN, PIGP, PIGQ, PIGS, PLCB1, POLG, PRRT2, PURA, RHOBTB2, SCN1A, SCN1B, SCN2A, SCN8A, SCN9A, SETBP1, SETD5, SLC13A5, SLC1A2, SLC25A22, SLC2A1, SMC1A, SNX14, SPTAN1, ST3GAL3, STXBP1, SYNGAP1, SYNJ1, SZT2, TARS2, TBC1D24, UBA5, UBE3A, VAMP2, VARS2, WARS2, WDR45, WWOX, YIF1B, YWHAG, and other genes associated with epilepsy-dyskinesia syndromes.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Having at least one pathogenic or likely pathogenic variant in one of the genes of interest:

AARS2, ADCY5, ALG13, AP3B2, AP4B1, AP4E1, AP4M1, AP4S1, ARX, ATP1A3, CACNA1A, CACNA1E, CACNA2D2, CDKL5, CSTB, DARS2, DLAT, DLD, DNM1, EARS2, EPG5, EPM2A, FARS2, FOXG1, FRRS1L, GABRA1, GABRA2, GABRB2, GABRB3, GABRG2, GNAO1, GRIA2, GRIA4, GRIN1, GRIN2A, GRIN2B, GRIN2D, HARS2, HNRNPU, HTT, IQSEC2, IRF2BPL, KCNA2, KCNB1, KCNC1, KCNMA1, KCNQ2, KCNQ3, KCNT1, LARS2, MECP2, MEF2C, MTND5, MTTK, MTTL1, NARS2, NHLRC1, PCDH12, PCDH19, PDE10A, PDE2, PDHA1, PDHB, PDHX, PDK3, PDP1, PIGA, PIGN, PIGP, PIGQ, PIGS, PLCB1, POLG, PRRT2, PURA, RHOBTB2, SCN1A, SCN1B, SCN2A, SCN8A, SCN9A, SETBP1, SETD5, SLC13A5, SLC1A2, SLC25A22, SLC2A1, SMC1A, SNX14, SPTAN1, ST3GAL3, STXBP1, SYNGAP1, SYNJ1, SZT2, TARS2, TBC1D24, UBA5, UBE3A, VAMP2, VARS2, WARS2, WDR45, WWOX, YIF1B, YWHAG, and other genes associated with epilepsy-dyskinesia syndromes.

Exclusion criteria

Exclusion Criteria:

  • Not having a pathogenic or likely pathogenic variants in the genes of interest
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
700 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Creation of Biorepository

    Establish a biobank for patients with epilepsy-dyskinesia syndromes, enabling quantitative profiling of biochemical biomarkers.

    Time frame: 5 years

  2. Assess Health-Related Quality of Life

    Conduct a health-related quality of life survey on epilepsy-dyskinesia syndrome patients to understand the priorities of and impact on patients and caregivers.

    Time frame: 5 years

  3. Understanding of Disease Spectrum

    To comprehensively understand the spectrum and association of movement and seizure disorders on both clinical and molecular levels.

    Time frame: 5 years

  4. Investigate the Efficacy of Symptomatic Treatments

    Investigate the efficacy of symptomatic treatments in addressing both seizure and movement disorders, aiming to identify shared therapeutic strategies.

    Time frame: 5 years

Secondary outcomes

  1. Establish Clinical Trial Readiness

    To facilitate an early diagnosis, enable counseling and anticipatory guidance of affected families and help define clinically meaningful endpoints for future interventional trials.

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2025 (actual). Primary completion is estimated for Jun 2030, 60 months after the start.

Of 193 non-industry observational studies under Epilepsy, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 179. This study's planned 60 months is close to that.

Counting every sponsor, half of 230 studies reached it within 59 months; a quarter within 24 and three quarters within 119.

How these figures are worked out, and which studies are left out of them.

Registered
May 4, 2025
First posted
May 13, 2025
StartActual
Jun 1, 2025
Primary completionEst.
Jun 1, 2030
CompletionEst.
Jul 2030
Last update
Aug 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06967727
Responsible party
Darius Ebrahimi-Fakhari (Principal Investigator, Boston Children's Hospital) — Principal investigator
First posted
May 13, 2025
Start date
Jun 1, 2025
Primary completion
Jun 1, 2030 (estimated)
Completion
Jul 2030 (estimated)
Last update
Aug 17, 2025

Study contacts

Darius Ebrahimi-Fakhari, MD, PhD
Contact
movementdisorders@childrens.harvard.edu
617-355-0097
Josh Rong, BS
Contact
movementdisorders@childrens.harvard.edu
617-355-0903

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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