NCT07714213 Aripiprazole Androgen-Insensitivity Syndrome Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07714213 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: 7 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07714213 is a hot trial to watch
Androgen-Insensitivity Syndrome is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07714213 is notable because it evaluates Aripiprazole in a Phase 2 design sponsored by Charité - Universitätsmedizin Berlin. 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 | NCT07714213 |
| Official title | Post-acute Infectious Syndrome - Aripiprazole Symptom Evaluation (PAIS-AriSE) (PAISE-AriSE) |
| Phase / status | Phase 2 / Not yet recruiting |
| Intervention | Aripiprazole |
| Sponsor | Charité - Universitätsmedizin Berlin |
| Geography | Germany |
| Enrollment | [object Object] |
| Primary endpoint | Intra-patient change in the Chalder Fatigue Scale (CFQ) by ≥ 3 points from baseline to week 9 in patients with PAIS. |
| Endpoint time frame | 9 weeks after first IMP intake |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
Post-acute infectious syndrome (PAIS), including post-COVID-19 condition (PCC or Long COVID), can develop after an infection and may cause persistent symptoms such as fatigue, problems with memory and concentration ("brain fog"), mood changes, and reduced quality of life. In some people, these symptoms continue for months or longer and can substantially affect daily activities. Currently, there are no approved treatments that specifically target these symptoms. Aripiprazole is a medicine that is approved to treat certain psychiatric disorders. At low doses, it may affect brain signaling and immune processes that are thought to contribute to symptoms experienced by people with PAIS. Small observational studies have suggested that low-dose aripiprazole may improve symptoms such as fatigue and cognitive impairment in people with related conditions, but its effectiveness and safety have not yet been confirmed in a randomized controlled tria
Allocation is Randomized, masking is Quadruple, and the intervention model is Crossover Assignment. Planned enrollment of [object Object] participants across Germany 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.
- Intra-patient change in the Chalder Fatigue Scale (CFQ) by ≥ 3 points from baseline to week 9 in patients with PAIS. (9 weeks after first IMP intake) — The CFQ assesses the extent and severity of fatigue and has been used in multiple randomized controlled trials of behavioral interventions in patients with ME/CFS. Each of the 11 items is rated on a 4-point scale, resulting in a total score ranging from 0 (no symptoms) to 33 (maximum symptom severity). In this trial, intra-patient change in CFQ by ≥3 points from baseline to week 9 will be interpreted as meaningful im
Readout outlook and evidence gap
The current protocol points to [object Object] 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: Aripiprazole 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: Charité - Universitätsmedizin Berlin is resolved to a normalized organization record in Germany. 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
NCT07714213 provides a focused lens on Androgen-Insensitivity Syndrome development. Its value will be determined by whether Aripiprazole can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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