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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003898-94 | EudraCT Number |
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This study will evaluate the long-term safety and tolerability of RO7234292 (RG6042) in participants who have completed other F. Hoffmann-La Roche, Ltd.-sponsored and/or Genentech-sponsored studies in the Huntington's disease (HD) in the development program for RG6042.
Entry into the study should occur at the time the participant completes participation in one of the preceding studies. Upon completion of the inclusion visit, eligible participants will receive either RO7234292 (RG6042) every 8 weeks (Q8W) or RO7234292 (RG6042) every 16 weeks (Q16W) by the bolus intrathecal injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RO7234292 (RG6042) Q8W | Experimental | Participants who received open-label RO7234292 Q4W in a preceding study or who received RO7234292 Q4W in this study may be randomly allocated to receive RO7234292 Q8W. Participants who previously received open-label of RO7234292 Q8W in a preceding study or are currently receiving RO7234292 Q8W in this study will receive RO7234292 Q8W. Participants who previously received placebo, or did not previously receive treatment with RO7234292 or received short-term treatment with a treatment-free follow-up period may be randomly allocated to receive RO7234292 Q8W. Participants who previously received blinded placebo Q8W may receive RO7234292 Q8W. Participants who received blinded RO7234292 Q8W will receive open-label RO7234929 Q8W. Participants who received blinded placebo Q8W may receive RO7234292 Q8W. Participants who received blinded RO7234292 Q4W or blinded placebo Q4W may be randomly allocated to receive open-label of RO7234292 Q8W. |
|
| RO7234292 (RG6042) Q16W | Experimental | Participants who previously received open-label RO7234292 Q4W in a preceding study or who received RO7234292 Q4W in this study may be randomly allocated to receive RO7234292 Q16W. Participants who previously received placebo in a preceding study or did not previously receive treatment with RO7234292 or received short-term treatment with a treatment-free follow-up period may be randomly allocated to receive RO7234292 Q16W. Participants who previously received blinded placebo Q8W will receive RO7234292 Q8W. Participants who previously received blinded RO7234292 Q16W will receive open-label RO7234292 Q16W. Participants who received blinded RO7234292 Q4W or blinded placebo Q4W may be randomly allocated to receive open-label of RO7234292 Q16W. Participants who previously received open-label RO7234292 Q16W will receive open-label RO7234292 Q16W. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7234292 (RG6042) | Drug | Intrathecal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment Emergent Adverse Events | The reported are the treatment-emergent AEs with an onset date up to 5 months after last study drug intake. | Up to Approximately 3 Years |
| 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) | 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. | Up to approximately 3 Years |
| Change From Baseline in Cognition, Using Montreal Cognitive Assessment (MoCA) | 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. | Up to Approximately 3 Years |
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Inclusion Criteria:
Inclusion criteria of patients who were screened and eligible for the placebo-controlled Phase III Study BN40423 but could not be randomized prior to the close of Study BN40423 enrollment due to challenges relating to the COVID-19 pandemic:
Exclusion Criteria:
Exclusion criteria of patients who were screened and eligible for the placebo-controlled Phase III Study BN40423 but could not be randomized prior to the close of Study BN40423 enrollment due to challenges relation to the COVID-19 pandemic:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uab Medicine | Birmingham | Alabama | 35294 | United States | ||
| University of California San Diego |
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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Periods 1 and 2 are sequential. 15 from 17 participants from Period 1 Q4W were re-randomized to receive Tominersen 120 mg Q8W or Q16W in Period 2 randomly and blinded.
.
The study consists of Period 1 and 2. All participants (17) in the Q4W arm stopped Q4W dosing (Period 1) and 15 participants continued into the two Arms of Period 2. Due to the statistical outputs available, Period 1 and 2 are reported as Milestones below. None of the participants completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tominersen 120mg Q4W | Participants received open-label RO7234292 Q4W in this Arm |
| FG001 | Tominersen 120mg Q8W | Participants received open-label RO7234292 Q8W in this Arm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 2, 2021 |
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| La Jolla |
| California |
| 92093 |
| United States |
| Stanford Univ Medical Center | Palo Alto | California | 94304 | United States |
| SC3 Research Group, Inc | Pasadena | California | 91105 | United States |
| CenExel Rocky Mountain Clinical Research, LLC | Englewood | Colorado | 80113 | United States |
| Georgetown University; Research Division, Psychiatry | Washington D.C. | District of Columbia | 20007 | United States |
| University of South Florida | Tampa | Florida | 33613 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| John Hopkins University School of Medicine | Baltimore | Maryland | 21287 | United States |
| Dent Neurological Institute | Amherst | New York | 14226 | United States |
| Columbia University | New York | New York | 10032-3725 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| The University of Texas Health Science Center at Houston; McGovern Medical School | Houston | Texas | 77030 | United States |
| Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie | Innsbruck | 6020 | Austria |
| University of British Columbia Hospital; Division of Neurology | Vancouver | British Columbia | V6T 2B5 | Canada |
| Centre for Movement Disorders | North YORK | Ontario | M3B 2S7 | Canada |
| Ottawa Hospital Research Institute | Ottawa | Ontario | K1Y 4E9 | Canada |
| Centre Hospitalier de l?Université de Montréal (CHUM) | Montreal | Quebec | H2X 0C2 | Canada |
| Charité - Universitätsmed. Berlin, Klinik für Psychiatrie und Psychotherapie; Abt. Neuropsychiatrie | Berlin | 10117 | Germany |
| St. Josef-Hospital, Neurologische Klinik der Ruhr-Uni; Huntington-Center NRW, Abt. Neurodegeneration | Bochum | 44791 | Germany |
| Universitätsklinikum Ulm; Klinik für Neurologie | Ulm | 89081 | Germany |
| IRCCS Casa Sollievo Della Sofferenza; Unità Ricerca e Cura Huntington e Malattie Rare | San Giovanni Rotondo (FG) | Apulia | 71013 | Italy |
| Fondazione IRCCS Istituto Neurologico Carlo Besta; U.O.C. Genetica Medica-Neurogenetica | Milan | Lombardy | 20133 | Italy |
| Universitair Medisch Centrum Groningen | Groningen | 9713 GZ | Netherlands |
| LUMC | Leiden | 2333 ZA | Netherlands |
| Hospital Universitario de Badajoz; Servicio de Neurología | Badajoz | 06080 | Spain |
| Hospital Clinic Servicio de Neurologia | Barcelona | 08036 | Spain |
| Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia | Barcelona | 08041 | Spain |
| Hospital Universitario de Burgos. Servicio de Neurología | Burgos | 09006 | Spain |
| Hospital Ramon y Cajal; Servicio de Neurologia | Madrid | 28034 | Spain |
| Fundacion Jimenez Diaz; Servicio de Neurología | Madrid | 28040 | Spain |
| Hospital Universitario Virgen Macarena; Servicio de Neurologia | Seville | 41009 | Spain |
| Birmingham and Solihull Mental Health Foundation Trust; Institute of Clinical Sciences | Birmingham | B15 2TT | United Kingdom |
| Cambridge Centre for Brain Repair; Department of Clinical Nuerosciences, Addenbrookes Hospital | Cambridge | CB2 0SP | United Kingdom |
| University Hospital of Wales; Division of Psychological Medicine and Clinical Neurosciences | Cardiff | CF14 4XW | United Kingdom |
| University College London Hospitals NHS Foundation Trust - University College Hospital | London | NW1 2PG | United Kingdom |
| Central Manchester University Hospitals NHS Foundation Trust; Manchester Centre for Genomic Medicine | Manchester | M13 9WL | United Kingdom |
| FG002 | Tominersen 120mg Q16W | Participants received open-label RO7234292 Q16W in this Arm |
| Period 1 | Period 1 has only 1 arm with 17 participants of which 15 were transferred to two Arms of Period 2 (8 and 7 participants, see below) |
|
| Period 2 | Period 2 has 2 arms: Tominersen 120mg Q8W (8 participants from Period 1 and 138 new participants enrolled) and Tominersen 120mg Q16W (7 participants from Period 1 and 81 new enrolled). There were no participants in arm Tominersen 120mg Q4W. |
|
| COMPLETED | None of the participants completed the study |
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| NOT COMPLETED |
|
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In Period 1 Milestone, 17 participants received 120 mg Tominersen Q4W Arm.
In the Milestone Period 2, 138 and 81 participants received 120 mg Tominersen Q8W and Q16W respectively, with 15 participants from the In Period 1 Milestone Arm. 8 and 7 participants from Period 1 joined the two arms of Period 2. Period 2 did not have the arm Tominersen 120mg Q4W.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tominersen 120mg Q4W | Participants received open-label RO7234292 Q4W in this Arm |
| BG001 | Tominersen 120mg Q8W | Participants received open-label RO7234292 Q8W in this Arm |
| BG002 | Tominersen 120mg Q16W | Participants received open-label RO7234292 Q16W in this Arm |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Population description: In the Milestone Period 2, 146 and 88 participants received 120 mg Tominersen Q8W and Q16W respectively, with 15 participants from the In Period 1 Milestone Arm. There is no data to report separately for Milestone Periods 1 and 2 as no such statistical analyses were performed without 15 participants from the Milestone Period 1 in Milestone Period 2. | After Period 1, 15 patients continued to Period 2 with re-randomization | Mean | Standard Deviation | Years |
| ||||||||
| Sex: Female, Male | Population Description: In the Milestone Period 2, 146 and 88 participants received 120 mg Tominersen Q8W and Q16W respectively, with 15 participants from the In Period 1 Milestone Arm. There is no data to report separately for Milestone Periods 1 and 2 as no such statistical analyses were performed without 15 participants from the Milestone Period 1 in Milestone Period 2. | After Period 1, 15 patients continued to Period 2 with re-randomization | Count of Participants | Participants |
| |||||||||
| Ethnicity (NIH/OMB) | Population Description: In the Milestone Period 2, 146 and 88 participants received 120 mg Tominersen Q8W and Q16W respectively, with 15 participants from the In Period 1 Milestone Arm. There is no data to report separately for Milestone Periods 1 and 2 as no such statistical analyses were performed without 15 participants from the Milestone Period 1 in Milestone Period 2. | After Period 1, 15 patients continued to Period 2 with re-randomization | Count of Participants | Participants |
| |||||||||
| Race (NIH/OMB) | Population Description: In the Milestone Period 2, 146 and 88 participants received 120 mg Tominersen Q8W and Q16W respectively, with 15 participants from the In Period 1 Milestone Arm. There is no data to report separately for Milestone Periods 1 and 2 as no such statistical analyses were performed without 15 participants from the Milestone Period 1 in Milestone Period 2. | After Period 1, 15 patients continued to Period 2 with re-randomization | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Treatment Emergent Adverse Events | The reported are the treatment-emergent AEs with an onset date up to 5 months after last study drug intake. | Safety Population | Posted | Number | Percentage of Participants | Up to Approximately 3 Years |
|
|
| ||||||||||||||||||||||||||||||||
| 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) | 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. | 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 | Posted | Number | Number of participants | Up to approximately 3 Years |
| ||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Cognition, Using Montreal Cognitive Assessment (MoCA) | 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. | 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. | Posted | Mean | Standard Deviation | Score of a Scale | Up to Approximately 3 Years |
|
Up to Approx. 3 Years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tominersen 120mg Q4W | Participants received open-label RO7234292 Q4W in this Arm | 1 | 14 | 1 | 14 | 12 | 14 |
| EG001 | Tominersen 120 mg Q8W | Participants received open-label RO7234292 Q8W in this Arm | 0 | 143 | 17 | 143 | 99 | 143 |
| EG002 | Tominersen 120 mg Q16W | Participants received open-label RO7234292 Q16W in this Arm | 1 | 88 | 9 | 88 | 56 | 88 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Phimosis | Congenital, familial and genetic disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cyst | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Acarodermatitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Arachnoiditis | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Balance disorder | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chorea | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Normal pressure hydrocephalus | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Parkinsonism | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute stress disorder | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dissociative disorder | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Suicidal behaviour | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Euthanasia | Surgical and medical procedures | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Eye contusion | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Foreign body aspiration | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
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| CSF protein increased | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Vitamin D decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Enthesopathy | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Fracture pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Limb mass | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Vertebral foraminal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vertebral osteophyte | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Aphasia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Ataxia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebellar atrophy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebral ventricle dilatation | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Coordination abnormal | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Dysarthria | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Extensor plantar response | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Hypotonia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Motor dysfunction | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Parkinsonism | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pleocytosis | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Post-traumatic headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Affect lability | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Mar 16, 2023 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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Not provided
| ID | Term |
|---|---|
| C000718631 | tominersen |
Not provided
Not provided
Not provided
|
| Period 2 |
|
|
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| Period 2 |
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| Period 2 |
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| Period 2 |
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Participants received open-label RO7234292 Q8W in this Arm |
| OG002 | Tominersen 120mg Q16W | Participants received open-label RO7234292 Q16W in this Arm |
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| OG003 | Tominersen 120mg Q8W (With Loading) | Participants received open-label RO7234292 Q8W with prior treatment with RO7234292 Q8W |
| OG004 | Tominersen 120mg Q8W (Prior BP40410) | Participants received open-label RO7234292 Q8W with prior treatment with RO7234292 Q4W in study BP40410 |
| OG005 | Tominersen 120mg Q16W (Prior Q4W) | Participants received open-label RO7234292 Q16W after having received Q4W treatment previously |
| OG006 | Tominersen 120mg Q16W (No Loading) | Participants received open-label RO7234292 Q16W without prior treatment with RO7234292 |
| OG007 | Tominersen 120mg Q16W (Prior BP40410) | Participants received open-label RO7234292 Q16W with prior treatment with RO7234292 Q4W in study BP40410 |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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