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NCT05522361 · ClinicalTrials.gov registry record · Phase 4
Risdiplam in Patients With Spinal Muscular Atrophy Previously Treated With Nusinersen
A Phase 4 study of Spinal Muscular Atrophy, sponsored by Clinic for Special Children.
- Active
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT05522361 is a Phase 4 study of Spinal Muscular Atrophy that is active but no longer recruiting, run by Clinic for Special Children. The registered enrollment target is 10 participants, below the 109-participant average among 22 other Spinal Muscular Atrophy trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05522361, a Phase 4 study of Spinal Muscular Atrophy, is active but no longer recruiting, sponsored by Clinic for Special Children.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Risdiplam Exchange (RISE) is a study of spinal muscular atrophy (SMA) patients who crossover to 36 months of open-label risdiplam monotherapy following a comparable period of nusinersen treatment. The schedule of assessments (SOAs) carry over seamlessly for the cohort from studies done while treated with nusinersen and continue to track the most informative outcomes from that trial (e.g. nine hole peg test and grip strength), while adding the Box and Block Test (BBT) as an additional measure of upper limb endurance and function.
Conditions Studied
Interventions
- DRUG Risdiplam
Study Locations (1)
Pennsylvania
- Clinic for Special Children - Strasburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-11-06 |
| Est. Completion | 2026-06-15 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05522361
The ClinicalTrials.gov registry entry for NCT05522361 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 109-participant average among 22 other Spinal Muscular Atrophy trials with a reported enrollment target (91% lower). The listed sponsor is Clinic for Special Children, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Spinal Muscular Atrophy appearing as the primary indexed condition, and to 1 intervention - of which Risdiplam is the first listed.
NCT05522361 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05522361 about?
NCT05522361 is a clinical study titled "Risdiplam in Patients With Spinal Muscular Atrophy Previously Treated With Nusinersen". Risdiplam Exchange (RISE) is a study of spinal muscular atrophy (SMA) patients who crossover to 36 months of open-label risdiplam monotherapy following a comparable period of nusinersen treatment. The schedule of assessments (SOAs) carry over seamlessly for the cohort from studies done while treated...
What is the current status of trial NCT05522361?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2022-11-06. Estimated completion is 2026-06-15.
What conditions does trial NCT05522361 study?
This clinical trial studies the following conditions: Spinal Muscular Atrophy.
What interventions are being tested in trial NCT05522361?
The interventions under investigation include: Risdiplam (DRUG).
Who is sponsoring clinical trial NCT05522361?
This trial is sponsored by Clinic for Special Children, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05522361 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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