Trial · NCT05217628
An Efficacy and Safety Study of Basimglurant (NOE-101) in Patients With Trigeminal Neuralgia.
NCT05217628, Phase 2, Phase 3, Active not recruiting, Noema Pharma AG
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Efficacy and Safety Study of Basimglurant (NOE-101) in Patients With Trigeminal Neuralgia. Trials, record NCT05217628. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05217628
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy and Safety Study of Basimglurant (NOE-101) in Patients With Trigeminal Neuralgia.
- NCT number
- NCT05217628
- Status
- Active not recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 166 participants, actual
- Lead sponsor
- Noema Pharma AG
- Conditions
- Trigeminal Neuralgia
- Interventions
- Basimglurant, Placebo
- First posted
- 2022-02-01
- Last updated
- 2026-01-23
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes0
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.
Data dates
The day each source was copied for this release.
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 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/NCT05217628
GET https://conductscience.org/api/trials/v1/NCT05217628/registered?page=2