Trial · NCT05818943
Honeycomb: Evaluation of Radiprodil in Children with GRIN-related Disorder
NCT05818943, Phase 1, Active not recruiting, GRIN Therapeutics, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Honeycomb: Evaluation of Radiprodil in Children with GRIN-related Disorder. Trials, record NCT05818943. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05818943
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Honeycomb: Evaluation of Radiprodil in Children with GRIN-related Disorder
- NCT number
- NCT05818943
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 24 participants, estimated
- Lead sponsor
- GRIN Therapeutics, Inc.
- Conditions
- GRIN-related Disorders
- Interventions
- Radiprodil
- First posted
- 2023-04-19
- Last updated
- 2024-11-15
- Other registries' IDs
- eudract:2022-000317-14
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (SAEs), TEAEs Leading to Discontinuation and Severity of TEAEs | through study completion (average of 2 years). | Frequency, type, severity and duration of adverse events, serious adverse events and adverse drug reactions. |
| Primary | Maximum Plasma concentration of radiprodil (Cmax) | Titration Visit 1 (week 5): 0,1,2,4,6,8,10,12 hours post-dose. Titration Visits 2,3,4 (week 6 to 11) and Maintenance Visit 4 (week 20): 0,1,2,5 hours post-dose. | |
| Primary | Pharmacokinetic plasma concentration of radiprodil: half-life (T1/2) | Titration Visit 1 (week 5): 0,1,2,4,6,8,10,12 hours post-dose. Titration Visits 2,3,4 (week 6 to 11) and Maintenance Visit 4 (week 20): 0,1,2,5 hours post-dose. | |
| Primary | Plasma concentration of radiprodil versus time, area under the curve (AUCt) | Titration Visit 1 (week 5): 0,1,2,4,6,8,10,12 hours post-dose. Titration Visits 2,3,4 (week 6 to 11) and Maintenance Visit 4 (week 20): 0,1,2,5 hours post-dose. | |
| Primary | Pharmacokinetic plasma concentration of radiprodil, clearance (Cl) | Titration Visit 1 (week 5): 0,1,2,4,6,8,10,12 hours post-dose. Titration Visits 2,3,4 (week 6 to 11) and Maintenance Visit 4 (week 20): 0,1,2,5 hours post-dose. | |
| Primary | Pharmacokinetic plasma concentration of radiprodil, Time corresponding to occurrence of Cmax (Tmax) | Titration Visit 1 (week 5): 0,1,2,4,6,8,10,12 hours post-dose. Titration Visits 2,3,4 (week 6 to 11) and Maintenance Visit 4 (week 20): 0,1,2,5 hours post-dose. | |
| Secondary | Percent change from baseline in V-EEG seizure burden | Baseline (week 5) to study completion (average of 2 years). | Assessed by 8- to 24- hour video electroencephalogram |
| Secondary | Change from baseline in seizure frequency | Baseline (week 5) to study completion (average of 2 years). | Assessed by seizure diaries |
| Secondary | Aberrant Behavior Checklist-Community (ABC-C) | Baseline (week 5) to study completion (average of 2 years). | The ABCC is a standardized 58-item caregiver-reported problem-behavior rating scale, originally designed to assess treatment effects in people with intellectual disabilities. Each item is scored from 0 (never a problem) to 3 (severe problem). Items load onto one of five empirically derived subscales: Irritability, Agitation, \& Crying (15 items); Lethargy/Social Withdrawal (16 items); Stereotypic Behavior (7 items); Hyperactivity/Noncompliance (16 items); and Inappropriate Speech (4 items). A total score would range from 0 to 174. |
| Secondary | Caregiver Global Impression of Change (CaGI-C) | Baseline (week 5) to study completion (average of 2 years). | The CaGI-C is a 7-point caregiver-rated scale ranging from 1 (very much improved) to 7 (very much worse). |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 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/NCT05818943
GET https://conductscience.org/api/trials/v1/NCT05818943/registered