Trial · NCT05206773
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent change from baseline at 6 months in the most bothersome symptom of 3 Fabry Disease Patient-Reported Outcome (FD-PRO) items (neuropathic pain in upper extremities, neuropathic pain in lower extremities, or abdominal pain) | From baseline to 6 months | |
| Primary | Percent change from baseline at 12 months in the most bothersome symptom of 3 Fabry Disease Patient-Reported Outcome (FD-PRO) items (neuropathic pain in upper extremities, neuropathic pain in lower extremities, or abdominal pain) | From baseline to 12 months | |
| Secondary | Percent change in plasma globotriaosylsphingosine (lyso-GL-3) | From baseline to 6 month and 12 months | |
| Secondary | Frequency of rescue pain medication use | From baseline to 6 months and 12 months | Number of days with use of rescue pain medications during the 6-month treatment period, divided by duration of the 6-month treatment period and multiplied by 100. The same definition will be used for the 12-month period. |
| Secondary | Change in the percentage of days with at least 1 stool reflecting diarrhea (Bristol Stool Form Scale [BSFS] Type 6 or 7) | From baseline to 6 month and 12 months | |
| Secondary | Change in tiredness component of FD-PRO | From baseline to 6 month and 12 months | |
| Secondary | Proportion of responders in neuropathic or abdominal pain, as assessed by FD-PRO | At 6 months and 12 months | Response is defined as at least a 30% decrease from baseline in the most bothersome of 3 FD-PRO items between neuropathic pain in upper extremities, neuropathic pain in lower extremities, and abdominal pain |
| Secondary | Number of participants with adverse event (AE) and serious adverse event (SAE) | From baseline to 6 month and 12 months | |
| Secondary | Change in the lens clarity (new or worsening lens opacities) by ophthalmological examination (by slit lamp exam at Visit 2 and Visit 6) | From baseline to 12 months | |
| Secondary | Change in Beck Depression Inventory-II (BDI-II) score | From baseline to 6 month and 12 months | |
| Secondary | Plasma venglustat concentrations at prespecified visits over the study duration | From baseline to 6 month and 12 months | |
| Secondary | Maximum venglustat plasma concentration (Cmax) | From baseline to 6 month and 12 months | |
| Secondary | Time to maximum venglustat plasma concentration (tmax) | From baseline to 6 month and 12 months | |
| Secondary | Area under the venglustat plasma concentration versus time curve from time 0 to 24 hours (AUC0-24) | From baseline to 6 month and 12 months |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05206773/registered