Trial · NCT03842969
An Open-Label Extension Study to Evaluate Long-Term Safety and Tolerability of RO7234292 (RG6042) in Huntington's Disease Participants Who Participated in Prior Roche and Genentech Sponsored Studies
NCT03842969, Phase 3, Completed, Hoffmann-La Roche; results first posted 2023-08-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open-Label Extension Study to Evaluate Long-Term Safety and Tolerability of RO7234292 (RG6042) in Huntington's Disease Participants Who Participated in Prior Roche and Genentech Sponsored Studies. Trials, record NCT03842969. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03842969
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-Label Extension Study to Evaluate Long-Term Safety and Tolerability of RO7234292 (RG6042) in Huntington's Disease Participants Who Participated in Prior Roche and Genentech Sponsored Studies
- NCT number
- NCT03842969
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 236 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Huntington Disease
- Interventions
- RO7234292 (RG6042)
- First posted
- 2019-02-15
- Last updated
- 2023-08-31
- Other registries' IDs
- eudract:2018-003898-94
- Results first posted
- 2023-08-31
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Treatment Emergent Adverse Events | Up to Approximately 3 Years | The reported are the treatment-emergent AEs with an onset date up to 5 months after last study drug intake. |
| Primary | Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia Suicide Severity Rating Scale (C-SSRS) | Up to approximately 3 Years | C-SSRS is to assess suicidal ideation and behavior. 4 constructs measured: severity of ideation, intensity of ideation, behavior, and lethality of actual suicide attempts. Yes/No data collected for 10 categories, composite endpoints based on the categories are followed over time to monitor safety. Composite endpoint of suicidal ideation (1-5), n and (%) are the number and % of who experience any of the five suicidal ideation events at least once after receiving the first dose of study medication. Composite endpoint of suicidal behavior (6-10), n and (%) are the number and percent of patients who experience any 1of 5 suicidal behavior events at least 1 after receiving the 5 dose of study medication. Composite endpoint of suicidal ideation or behavior (1-10), n and (%) are the number and % of patients who experience any 1 the 10 suicidal ideation or behavior events at least once after receiving the first dose of study medication. |
| Primary | Change From Baseline in Cognition, Using Montreal Cognitive Assessment (MoCA) | Up to Approximately 3 Years | MoCA contains a series of basic assessments, including attention and visuospatial tasks. The total score ranges from 0-30, where lower scores indicate greater impairment. MOCA01-Total scores are reported. The data presented are absolute scores for baseline and change from baseline for post-baseline assessments. All Arms except Tominersen 120mg Q4W (Period 1) belong to the Milestone Period 2. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Treatment Emergent Adverse Events | Up to Approximately 3 Years | Safety Population | Percentage of Participants | NUMBER |
| PRIMARY | Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia Suicide Severity Rating Scale (C-SSRS) | Up to approximately 3 Years | Safety Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) are included. All other data were not evaluable due to participants' discontinuation | Number of participants | NUMBER |
| PRIMARY | Change From Baseline in Cognition, Using Montreal Cognitive Assessment (MoCA) | Up to Approximately 3 Years | Safety Population. Data evaluable participants were reported, all other data are not available. Only those participants who contributed and whose data were analyzed for data are reported in the table. | Score of a Scale | MEAN |
Source ClinicalTrials.gov
Results by group115
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Treatment Emergent Adverse Events | Tominersen 120mg Q4W | 71.4 | Percentage of Participants | ||
| Percentage of Participants With Treatment Emergent Adverse Events | Tominersen 120 mg Q8W | 83.9 | Percentage of Participants | ||
| Percentage of Participants With Treatment Emergent Adverse Events | Tominersen 120 mg Q16W | 81.8 | Percentage of Participants | ||
| Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia Suicide Severity Rating Scale (C-SSRS) | Tominersen 120mg Q4W | Suicidal Ideation (1-5) -Wish to Be Dead | 1 | Number of participants | |
| Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia Suicide Severity Rating Scale (C-SSRS) | Tominersen 120 mg Q8W | Suicidal Ideation (1-5) -Wish to Be Dead | 16 | Number of participants | |
| Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia Suicide Severity Rating Scale (C-SSRS) | Tominersen 120mg Q16W | Suicidal Ideation (1-5) -Wish to Be Dead | 3 | Number of participants | |
| Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia Suicide Severity Rating Scale (C-SSRS) | Tominersen 120mg Q4W | Suicidal Ideation (1-5) -Non-specific Active Suicidal Thoughts | 0 | Number of participants | |
| Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia Suicide Severity Rating Scale (C-SSRS) | Tominersen 120 mg Q8W | Suicidal Ideation (1-5) -Non-specific Active Suicidal Thoughts | 9 | Number of participants | |
| Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia Suicide Severity Rating Scale (C-SSRS) | Tominersen 120mg Q16W | Suicidal Ideation (1-5) -Non-specific Active Suicidal Thoughts | 1 | Number of participants | |
| Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia Suicide Severity Rating Scale (C-SSRS) | Tominersen 120mg Q4W | Suicidal Ideation (1-5) -Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act | 0 | Number of participants |
1 to 10 of 115Source ClinicalTrials.gov
See all 115 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tominersen 120mg Q4W | 17 | |
| Overall Study | STARTED | Tominersen 120mg Q8W | 138 | |
| Overall Study | STARTED | Tominersen 120mg Q16W | 81 | |
| Overall Study | Period 1 | Tominersen 120mg Q4W | 17 | |
| Overall Study | Period 1 | Tominersen 120mg Q8W | 0 | |
| Overall Study | Period 1 | Tominersen 120mg Q16W | 0 | |
| Overall Study | Period 2 | Tominersen 120mg Q4W | 0 | |
| Overall Study | Period 2 | Tominersen 120mg Q8W | 146 | |
| Overall Study | Period 2 | Tominersen 120mg Q16W | 88 | |
| Overall Study | COMPLETED | Tominersen 120mg Q4W | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events303
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Tinnitus | Ear and labyrinth disorders | Tominersen 120mg Q4W | 1 | 14 | 1 |
| other | Tinnitus | Ear and labyrinth disorders | Tominersen 120 mg Q8W | 2 | 143 | 2 |
| other | Tinnitus | Ear and labyrinth disorders | Tominersen 120 mg Q16W | 1 | 88 | 1 |
| other | Vision blurred | Eye disorders | Tominersen 120mg Q4W | 1 | 14 | 1 |
| other | Vision blurred | Eye disorders | Tominersen 120 mg Q8W | 0 | 143 | 0 |
| other | Vision blurred | Eye disorders | Tominersen 120 mg Q16W | 1 | 88 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Tominersen 120mg Q4W | 1 | 14 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Tominersen 120 mg Q8W | 9 | 143 | 9 |
| other | Diarrhoea | Gastrointestinal disorders | Tominersen 120 mg Q16W | 5 | 88 | 6 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Tominersen 120mg Q4W | 1 | 14 | 1 |
1 to 10 of 303Source ClinicalTrials.gov
See all 303 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tominersen 120mg Q4W | 1 | 14 |
| Total, all-cause mortality | Tominersen 120 mg Q8W | 0 | 143 |
| Total, all-cause mortality | Tominersen 120 mg Q16W | 1 | 88 |
| Total, other adverse events | Tominersen 120mg Q4W | 12 | 14 |
| Total, other adverse events | Tominersen 120 mg Q8W | 99 | 143 |
| Total, other adverse events | Tominersen 120 mg Q16W | 56 | 88 |
| Total, serious adverse events | Tominersen 120mg Q4W | 1 | 14 |
| Total, serious adverse events | Tominersen 120 mg Q8W | 17 | 143 |
| Total, serious adverse events | Tominersen 120 mg Q16W | 9 | 88 |
Source ClinicalTrials.gov
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/NCT03842969
GET https://conductscience.org/api/trials/v1/NCT03842969/results?page=2