A Study to Assess Safety, Tolerability, Pharmacokinetics, and Efficacy of S247240 in Adult Male Participants With Fragile X Syndrome
NCT07930520, Phase 2, Not yet recruiting, Institut de Recherches Internationales Servier (I.R.I.S.)
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Study to Assess Safety, Tolerability, Pharmacokinetics, and Efficacy of S247240 in Adult Male Participants With Fragile X Syndrome | ClinicalTrials.gov |
| NCT number | NCT07930520 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 100 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Institut de Recherches Internationales Servier (I.R.I.S.) | ClinicalTrials.gov |
| Conditions | Fragile X Syndrome (FXS) | ClinicalTrials.gov |
| Interventions | S247240 Low dose, S247240 Middle dose, S247240 High dose, Placebo | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Number of Adverse Events (AEs) | Through Week 16 | ClinicalTrials.gov | |
| Primary | Severity of AEs | Through Week 16 | ClinicalTrials.gov | |
| Secondary | Change from baseline at Week 14 in NRS-FXS score | Through Week 14 | The Numerical Rating Scale - Fragile X Syndrome (NRS-FXS) is based on patient-specific behaviors within the domains of Daily Function, Language/Communication, and Emotions and behaviors. The score in each domain ranges from 0 to 10, with higher numbers indicating better functioning. This will be completed by the participant's caregiver. | ClinicalTrials.gov |
| Secondary | Change from baseline at Week 14 in CGI-S score | Through Week 14 | The Clinical Global Impression-Severity (CGI-S) score ranges from 1 to 7, with higher numbers indicating worse functioning. This will be completed by the clinician. | ClinicalTrials.gov |
| Secondary | Change from baseline to Week 14 in CGI-I score | Through Week 14 | The Clinical Global Impression-Improvement (CGI-I) score ranges from 1 to 7, with higher numbers indicating a worsening in functioning. This will be completed by the clinician. | ClinicalTrials.gov |
| Secondary | Change from baseline at Week 14 in ABC-C FXS score | Through Week 14 | The Aberrant Behavior Checklist - Community, Fragile X Syndrome (ABC-C FXS) is a 58-item questionnaire that assesses the severity of behaviors. Each item is rated on a 4-point scale from 0 to 3 with higher numbers indicating worse functioning. This will be completed by the participant's caregiver. | ClinicalTrials.gov |
| Secondary | Change from baseline at Week 14 in NIH-TCB score | Through Week 14 | For the National Institutes of Health - Toolbox Cognition Battery (NIH-TCB) 6 Fluid Battery tests, higher scores indicate better cognitive functioning. Superior ability is 130; average is approx. 100 and less than 70 is impairment. This will be completed by the participant. | ClinicalTrials.gov |
| Secondary | Change from baseline to Week 14 in PARS score | Through Week 14 | The Pediatric Anxiety Rating Scale (PARS) ranges from 0 to 25, with higher numbers indicating worse functioning. This will be completed by a central clinician through a remote interview of the participant's caregiver. | ClinicalTrials.gov |
| Secondary | Change from baseline to Week 14 in ADAMS score | Through Week 14 | The Anxiety Depression and Mood Scale (ADAMS) contains 29 subscales, each of which has a score ranging from 0 to 3 with higher numbers indicating worse functioning. This will be completed by the participant's caregiver. | ClinicalTrials.gov |
| Secondary | Change from baseline to Week 14 in VABS-3 score | Through Week 14 | Each item of the Vineland Adaptive Behavior Scale Third Edition (VABS-3) ranges from 0 to 2. This yields an ABC score which ranges from 20 to 140, and sub-domain V-scale scores which range from 1 to 24. This will be completed by a central clinician through a remote interview of the participant's caregiver. | ClinicalTrials.gov |
| Secondary | Sleep quality as assessed by PSQI score | Through Week 16 | The Pittsburgh Sleep Quality Index (PSQI) ranges from 0 to 21, with higher numbers indicating worse sleep quality. This will be completed by the participant's caregiver. | ClinicalTrials.gov |
| Secondary | Quality of life as assessed by EQ-5D-5L score | Through Week 14 | The EuroQol-5Dimension-5Level (EQ-5D-5L) is a questionnaire assessing health status. It consists of 2 parts, one descriptive part assessing health in 5 dimensions, and one visual analogue scale which scores from 0 to 100, with higher scores indicating better health status. This will be completed by the participant's caregiver. | ClinicalTrials.gov |
| Secondary | Measured concentration at the end of a dosing interval at steady state (Ctrough) of S247240 in plasma | Through Week 16 | ClinicalTrials.gov | |
| Secondary | Observed maximum plasma concentration after administration (Cmax) of S247240 in plasma | Through Week 16 | ClinicalTrials.gov | |
| Secondary | Area Under the concentration time curve from time zero up to the next administration (AUCtau) of S247240 in plasma | Through Week 16 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.