CLINICAL TRIALS PROFILE FOR EVRYSDI
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All Clinical Trials for EVRYSDI
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT04718181 ↗ | Bioavailability and Bioequivalence of Two Risdiplam Tablets in Healthy Participants | Recruiting | Hoffmann-La Roche | Phase 1 | 2021-02-01 | The study is a randomized, single oral dose, crossover study in up to three parts to investigate the relative bioavailability and bioequivalence of two different formulations of risdiplam 5 mg (dispersible tablets) versus the current risdiplam oral solution formulation in healthy male and female participants. The effect of food on these two dispersible tablets and the current oral solution will be studied, as well as the effect of omeprazole on the dispersible tablets. |
| NCT05232929 ↗ | Long-Term Follow-Up Study of Risdiplam in Participants With Spinal Muscular Atrophy (SMA) | Not yet recruiting | Genentech, Inc. | Phase 4 | 2022-01-31 | A multi-center, longitudinal, prospective, non-comparative study to investigate the long-term safety and effectiveness of risdiplam, prescribed based on clinician judgment as per the Evrysdi® U.S. Package Insert (USPI) in adult and pediatric participants with spinal muscular atrophy (SMA). In this study, participants will be followed for up to 5 years from enrollment or until withdrawal of consent, loss to follow-up, or death. |
| NCT05808764 ↗ | A Study to Investigate the Pharmacokinetics and Safety of Risdiplam in Infants With Spinal Muscular Atrophy | Not yet recruiting | Hoffmann-La Roche | Phase 4 | 2023-06-01 | This study will evaluate the pharmacokinetics (PK) and safety of risdiplam in participants with spinal muscular atrophy (SMA) under 20 days of age at first dose. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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