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Trial · NCT06528392

Efgartigimod for Stiff Person Syndrome (ESPS)

NCT06528392, Phase 2, Not yet recruiting, University of South Florida

3 sourcestrials-2026-11-12-0.4.0

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ConductScience Library. Efgartigimod for Stiff Person Syndrome (ESPS). Trials, record NCT06528392. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06528392

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Efgartigimod for Stiff Person Syndrome (ESPS)
NCT number
NCT06528392
Status
Not yet recruiting
Phases
Phase 2
Enrollment
10 participants, estimated
Lead sponsor
University of South Florida
Conditions
Stiff-Person Syndrome
Interventions
Efgartigimod
First posted
2024-07-30
Last updated
2025-04-11

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryDistribution of Stiffness Index (DSI)From enrollment to the end of treatment at week 13
DSI is a validated indicator or stiffness. Scores range from 0 to 6 and reflect the extent of stiffness. One point is given for stiffness in each of the following areas: lower trunk, upper trunk, legs, arms, face and abdomen.
Primaryheightened sensitivity score (HSS)From enrollment to end of treatment at week 13
HSS measures changes in the frequency of spasms. Scores range from 1 to 7; one point given for each source or type of spasm: unexpected noises, visual stimuli, somatosensory stimuli, voluntary activities, emotional upset or stress, no specific stimuli, or nocturnal spasms.
SecondaryProportion of patients with SPS who are treatment respondersenrollment to end of 13 weeks
Proportion of patients with SPS who are treatment responders, defined as: \>= 2 points reduction in the distribution of stiffness index (DSI) AND \>= 1 point reduction in heightened sensitivity score (HSS)
SecondaryThe duration of time patients maintain responder statusfrom enrollment to end of treatment at week 13A responder is defined as one having \>= 2 points reduction in the distribution of stiffness index (DSI) AND \>= 1 point reduction in heightened sensitivity score (HSS)
SecondaryModified Rankin ScaleFrom enrollment to end of treatment at week 13

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release
trials-2026-11-12-0.4.0
Release manifest SHA-256
0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture
2026-11-12
Results copy, AACT
2026-03-23
NIH clinical studies file
2026-11-13

Source ClinicalTrials.gov

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT06528392

GET https://conductscience.org/api/trials/v1/NCT06528392/registered