NCT07773883 Solriamfetol Hydrochloride Attention Deficit Disorder With Hyperactivity Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07773883 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 1 September 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07773883 is a hot trial to watch
Attention Deficit Disorder With Hyperactivity is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07773883 is notable because it evaluates Solriamfetol Hydrochloride in a Phase 3 design sponsored by Axsome Therapeutics, Inc.. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07773883 |
| Official title | An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD |
| Phase / status | Phase 3 / Enrolling by invitation |
| Intervention | Solriamfetol Hydrochloride |
| Sponsor | Axsome Therapeutics, Inc. |
| Geography | United States |
| Enrollment | 300 |
| Primary endpoint | Treatment-Emergent Adverse Events (TEAEs) |
| Endpoint time frame | Up to 52 weeks |
| Primary completion / readout proxy | Not reported |
Protocol design and endpoint interpretation
This study is a Phase 3, multi-center, open-label trial to evaluate the long-term safety of solriamfetol in children and adolescents with ADHD.
Allocation is Non-Randomized, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of 300 participants across United States shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Treatment-Emergent Adverse Events (TEAEs) (Up to 52 weeks) — An AE is defined as treatment emergent if the first onset or worsening is after the first administration of the study drug and not more than 7 days after the last dose of study drug or 30 days after the last dose of study drug for SAEs.
Readout outlook and evidence gap
The current protocol points to Not reported as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: Solriamfetol Hydrochloride is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: Axsome Therapeutics, Inc. is resolved to a normalized organization record in United States. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07773883 provides a focused lens on Attention Deficit Disorder With Hyperactivity development. Its value will be determined by whether Solriamfetol Hydrochloride can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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