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Disease
Neurodevelopmental disorder with speech impairment and with or without seizures
Late-stage therapeutic development
24
Clinical trials
1
Associated genes
1
Related proteins
What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
Executive briefingUpdating summary…Momentum: Moderate
Key developments
- 6 clinical trials expected to report results, the earliest in Q1 2028.
Upcoming Milestones
- Q1 2028A Multicenter, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ONO-2017 in Japanese Patients With Partial Onset Seizures Aged 2 to Under 18 Years.
- Q3 2029A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
- Q4 2029A MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE LONG-TERM SAFETY AND TOLERABILITY OF BRIVARACETAM IN STUDY PARTICIPANTS WITH CHILDHOOD ABSENCE EPILEPSY OR JUVENILE ABSENCE EPILEPSY
- Q1 2030A Pharmaco-Imaging Trial of Mixed Amphetamine Salts for the Treatment of ADHD in Intellectually-intact Youth With Autism Spectrum Disorder
- Q1 2030Mechanistic Clinical Trial Evaluating the Role of the Metabotropic Glutamate Receptor Subtype 5 (mGluR5) in the Antidepressant Mechanism of Cognitive Behavioral Therapy for Insomnia (CBT-I)
Major developments
Major trial resultsHigh impact
Results posted2026-07-02
Upcoming trial readoutHigh impact
Results expected Q3 20292026-08-13
Clinical MilestonesView all 15Hide
Results posted
- 2026-07-02CPT-SMART for Treatment of PTSD and Cigarette SmokingResults posted
Results expected
- 2026-08-13A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of RAP-219 in Adult Participants With Focal SeizuresResults expected Q3 2029
- 2026-07-09A MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE LONG-TERM SAFETY AND TOLERABILITY OF BRIVARACETAM IN STUDY PARTICIPANTS WITH CHILDHOOD ABSENCE EPILEPSY OR JUVENILE ABSENCE EPILEPSYResults expected Q4 2029
- 2026-06-08CELESTE: Comparative Effectiveness Study of behavioraL and Drug-rElated inSomnia Therapies for pEri- and Post-menopausal PeopleResults expected Q1 2031
- 2026-05-18A Multicenter, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ONO-2017 in Japanese Patients With Partial Onset Seizures Aged 2 to Under 18 Years.Results expected Q1 2028
- 2026-03-06A Pharmaco-Imaging Trial of Mixed Amphetamine Salts for the Treatment of ADHD in Intellectually-intact Youth With Autism Spectrum DisorderResults expected Q1 2030
Recently completed
- 2026-06-10A Multicenter Open-Label Extension Study to Evaluate the Long-Term Safety of Cenobamate Adjunctive Therapy in Subjects With Primary Generalized Tonic-Clonic SeizuresCompleted
- 2026-04-30The Effects of Solriamfetol and CBT-I (Alone and in Combination) on Sleep Continuity, Sleepiness, Fatigue, and Performance in Patients With Insomnia DisorderCompleted
- 2026-01-20Investigation of Efficacy and Tolerability of Levetiracetam for Epilepsy in ElderlyCompleted
- 2025-12-31Biomarker-Driven Pharmacological Treatment for Autism Spectrum DisorderCompleted
- 2025-12-01Pragmatic Trial Comparing Weight Gain in Children With Autism Taking Risperidone Versus AripiprazoleCompleted
Other updates
- 2027-02-01Identification, Assessment, and Treatment of Tardive Dyskinesia With Valbenazine in Adults With Intellectual/Developmental Disabilities and Co-occurring Psychiatric and/or Behavioral DisordersWithdrawn
- 2026-03-12A Phase 2/3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BHV-7000 as Adjunctive Therapy in Subjects With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures, With Open-label ExtensionTerminated
- 2025-11-25Memantine for the Treatment of Social Deficits in Youth With Disorders of Impaired Social Interactions: A Randomized-controlled TrialTerminated
+7 more in the activity timeline below
Activity timeline15
- 2027-02-01ClinicalIdentification, Assessment, and Treatment of Tardive Dyskinesia With Valbenazine in Adults With Intellectual/Developmental Disabilities and Co-occurring Psychiatric and/or Behavioral DisordersWithdrawn
- 2026-08-13ClinicalA Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of RAP-219 in Adult Participants With Focal SeizuresResults expected Q3 2029
- 2026-07-09ClinicalA MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE LONG-TERM SAFETY AND TOLERABILITY OF BRIVARACETAM IN STUDY PARTICIPANTS WITH CHILDHOOD ABSENCE EPILEPSY OR JUVENILE ABSENCE EPILEPSYResults expected Q4 2029
- 2026-07-02ClinicalCPT-SMART for Treatment of PTSD and Cigarette SmokingResults posted
- 2026-06-10ClinicalA Multicenter Open-Label Extension Study to Evaluate the Long-Term Safety of Cenobamate Adjunctive Therapy in Subjects With Primary Generalized Tonic-Clonic SeizuresCompleted
- 2026-06-08ClinicalCELESTE: Comparative Effectiveness Study of behavioraL and Drug-rElated inSomnia Therapies for pEri- and Post-menopausal PeopleResults expected Q1 2031
- 2026-05-18ClinicalA Multicenter, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ONO-2017 in Japanese Patients With Partial Onset Seizures Aged 2 to Under 18 Years.Results expected Q1 2028
- 2026-04-30ClinicalThe Effects of Solriamfetol and CBT-I (Alone and in Combination) on Sleep Continuity, Sleepiness, Fatigue, and Performance in Patients With Insomnia DisorderCompleted
- 2026-03-12ClinicalA Phase 2/3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BHV-7000 as Adjunctive Therapy in Subjects With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures, With Open-label ExtensionTerminated
- 2026-03-06ClinicalA Pharmaco-Imaging Trial of Mixed Amphetamine Salts for the Treatment of ADHD in Intellectually-intact Youth With Autism Spectrum DisorderResults expected Q1 2030
Clinical trials
The current development programme across all trial phases.
Clinical programme
24
6
18
6
Late-stage studies
Recruiting
Recently completed
Associated genes
Genes associated with this disease in the canonical knowledge graph (Open Targets evidence). Number shows the association score.
Disease biology
Proteins whose encoding gene is associated with this disease, reached through the canonical gene→disease graph. Number shows the gene's association score.
References & data sources
- Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
- Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
- Related entities are derived from literature co-mention (studied together) — associative, not causal.