Trial · NCT05217628
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Period 1: Incidence and severity of adverse events, laboratory, vital signs and cardiovascular events. | 8 weeks | Change in pain as measured by the pain diary (TnED). |
| Primary | Period 2: Time to Loss of Efficacy or pain recurrence defined as the confirmed increase in the number of weekly paroxysms or re-emergence of continuous pain and/or the need for rescue medication. | 12 weeks | To assess the maintenance of effect on pain. |
| Primary | Open Label Extension: Incidence and severity of adverse events, laboratory, vital signs and cardiovascular events. | 52 weeks | To evaluate the long-term safety of basimglurant daily dosing. |
| Secondary | Period 2: Mean change in the total patient-rated Penn-Facial Pain Scale-Revised (Penn-FPS-R) scale compared with Period 2 baseline (BL2). | 12 weeks | Impact on facial pain. |
| Secondary | Period 2: Frequency of attacks (paroxysms). | 12 weeks | Impact on facial pain measured by patient rated scale via Penn-FPS-R |
| Secondary | Period 2: Severity of attacks (paroxysms). | 12 weeks | Impact on facial pain measured by patient rated scale via Penn-FPS-R |
| Secondary | Period 2: Severity of continuous pain. | 12 weeks | Impact on facial pain measured by patient rated scale via Penn-FPS-R |
| Secondary | Period 2: Duration of continuous pain. | 12 weeks | Impact on facial pain measured by patient rated scale via Penn-FPS-R |
| Secondary | Period 2: Change in Patient Global Impression of Change (P-GIC). | 12 weeks | Impact on facial pain. |
| Secondary | Period 2: Change in Medication Satisfaction Questionnaire (MSQ). | 12 weeks | Impact on facial pain. |
| Secondary | Open Label Extension: Frequency of attacks (paroxysms). | 52 weeks | Evaluate the continued efficacy of basimglurant on facial pain measured by patient rated scale via Penn-FPS-R |
| Secondary | Open Label Extension: Severity of attacks (paroxysms). | 52 weeks | Evaluate the continued efficacy of basimglurant on facial pain measured by patient rated scale via Penn-FPS-R |
| Secondary | Open Label Extension: Severity and duration of continuous pain reported in patient pain diary. | 52 weeks | Evaluate the continued efficacy of basimglurant on facial pain. |
| Secondary | Open Label Extension: Measure Global Impression of Severity as captured by PGI-S. | 52 weeks | Evaluate the continued efficacy of basimglurant on facial pain. |
| Other | Period 1: Mean change from Period 1 baseline (BL1) to Week 8 in the total patient-rated Penn-Facial Pain Scale-Revised (Penn-FPS-R) scale. | 8 weeks | Evaluate 8-week once daily basimglurant on pain associated with TN on the following: * Impact on Facial Pain * Patient perceived change of the pain * Pain assessments * Pain freedom * Patient medication satisfaction |
| Other | Period 1: Measure Global Impression of change from Period 1 baseline (BL1) to Week 8. | 8 weeks | Evaluate 8-week once daily basimglurant on pain associated with TN on the following: * Impact on Facial Pain * Patient perceived change of the pain * Pain assessments * Pain freedom * Patient medication satisfaction |
| Other | Period 1: Number and severity of attacks (paroxysms). | 8 weeks | Evaluate 8-week once daily basimglurant on pain associated with TN on the following: * Impact on Facial Pain * Patient perceived change of the pain * Pain assessments * Pain freedom * Patient medication satisfaction |
| Other | Period 1: Duration of continuous pain compared with BL1. | 8 weeks | Evaluate 8-week once daily basimglurant on pain associated with TN on the following as measured by patient rated scale via Penn-FPS-R: * Impact on Facial Pain * Patient perceived change of the pain * Pain assessments * Pain freedom * Patient medication satisfaction |
| Other | Period 1: Severity of continuous pain compared with BL1. | 8 weeks | Evaluate 8-week once daily basimglurant on pain associated with TN on the following as measured by patient rated scale via Penn-FPS-R: * Impact on Facial Pain * Patient perceived change of the pain * Pain assessments * Pain freedom * Patient medication satisfaction |
| Other | Period 1: Number of pain free days. | 8 weeks | Evaluate 8-week once daily basimglurant on pain associated with TN on the following: * Impact on Facial Pain * Patient perceived change of the pain * Pain assessments * Pain freedom * Patient medication satisfaction |
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/NCT05217628/registered