Trial · NCT05027997
Exploratory Study of Dipraglurant (ADX48621) for the Treatment of Patients With Blepharospasm
NCT05027997, Phase 2, Completed, Addex Pharma S.A.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Exploratory Study of Dipraglurant (ADX48621) for the Treatment of Patients With Blepharospasm. Trials, record NCT05027997. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05027997
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Exploratory Study of Dipraglurant (ADX48621) for the Treatment of Patients With Blepharospasm
- NCT number
- NCT05027997
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Addex Pharma S.A.
- Conditions
- Blepharospasm, Dystonia
- Interventions
- Dipraglurant, Placebo
- First posted
- 2021-08-31
- Last updated
- 2025-10-03
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and tolerability of dipraglurant as measured by incidence of adverse events | Baseline to Day 2 | The primary outcome will be testing the safety and tolerability of dipraglurant in patients with blepharospasm based on the incidence of adverse events reported by patients and/or as identified by the Investigator based on clinical assessments conducted during the study. |
| Primary | Computerized Motor Objective Rater (CMOR) analysis of blinking activity | Baseline to Day 2 | Video analysis, by an independent rater, of the mean proportion of eye closure time, severity of periocular spasms, and blink rate. Decreased eye closure time, severity of periocular spasms and blink rate indicates improvement of blepharospasm symptoms. |
| Primary | Skintronics wearable analysis of blinking activity | Baseline to Day 2 | Analysis of blinking activity as recorded on the Skintronics wearable device. Decreased blink activity indicates improvement of blepharospasm symptoms. |
| Secondary | Jankovic Rating Scale (JRS) severity score | Baseline to Day 2 | The JRS is a clinician rated scale for blepharospasm. The intensity of eyelid spasms is measured based on a 5 point grading system where 0 indicates no symptoms and 4 indicates the most severe symptoms. |
| Secondary | Jankovic Rating Scale (JRS) frequency score | Baseline to Day 2 | The JRS is a clinician rated scale for blepharospasm. The frequency of eyelid spasms is measured based on a 5 point grading system where 0 indicates no symptoms and 4 indicates highest frequency symptoms. |
| Secondary | Global Dystonia Severity Rating Scale (GDS) | Baseline to Day 2 | The GDS is a clinician rated scale for the assessment of dystonia severity across multiple body regions. Each body region is rated on a scale from 0-10 where 0 represents no dystonia and 10 represents severe dystonia. |
| Secondary | Blepharospasm Phenotyping Tool (BPT) | Baseline to Day 2 | The BPT is a clinician rated scale assessing 4 major phenotypic elements of blepharospasm using a 4 point scale for severity and frequency, where 0 indicates no symptoms and 4 indicates the highest frequency and/or most severe symptoms. |
| Secondary | Blepharospasm Severity Rating Scale (BSRS) | Baseline to Day 2 | The BSRS is a clinician rated scale for rating severity of blepharospasm based on 6 clinical features of the condition. A total score is generated based on the combined score for severity and frequency and where a higher value indicates more severe symptoms. |
| Secondary | Clinician's Global Impression of Severity (CGI-S) score | Baseline to Day 2 | The CGI-S score is used by the Investigator to determine, in a global sense, how severe the patients blepharospasm is in the context of other blepharospasm patients. Increased scores indicate more severe symptoms. |
| Secondary | Blepharospasm Disability Index (BSDI) | Baseline to Day 2 | The BSDI is a 6 item patient rated disability scale that measures how blepharospasm effects activities of daily living. Each item is scored on a 5 point scale to produce a total score of up to 30, where a higher individual item score and a higher total score indicate greater disability to the patient. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38310362 | DERIVED |
Source PubMed
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/NCT05027997
GET https://conductscience.org/api/trials/v1/NCT05027997/registered