A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7234292 (ISIS 443139) in Huntington's Disease Patients Who Participated in Prior Investigational Studies of RO7234292 (ISIS 443139)
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT03342053
Collaborator
(none)
46
9
2
21.2
5.1
0.2
Study Details
Study Description
Brief Summary
This study will test the safety, tolerability, pharmacokinetics and pharmacodynamics of RO7234292 administered intrathecally to adult patients with Huntington's Disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Extension Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7234292 (ISIS 443139) in Huntington's Disease Patients Who Participated in Prior Investigational Studies of RO7234292 (ISIS 443139)
Actual Study Start Date
:
Jan 2, 2018
Actual Primary Completion Date
:
Oct 8, 2019
Actual Study Completion Date
:
Oct 8, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: RO7234292 Monthly RO7234292 is administered every 28 days intrathecally for 14 months. |
Drug: RO7234292 (RG6042)
Intrathecal injection
Other Names:
|
| Experimental: RO7234292 Bimonthly RO7234292 is administered every 56 days intrathecally for 14 months following 2 monthly doses to serve as a loading dose. |
Drug: RO7234292 (RG6042)
Intrathecal injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Adverse Events [From baseline up to 18 months]
Adverse Events include Adverse Events that started at or after Date/Time of First Exposure to Treatment and procedure-related Adverse Events occurring before the start of treatment.
Secondary Outcome Measures
- RO7234292 CSF Trough Concentrations by Study Day Prior to Monthly and Bimonthly IT Administration of 120 mg RO7234292 (Primary Analysis) [From baseline to Day 421]
- CSF mHTT Protein Concentration Logarithmic Value Change in Geometric Mean (95%CI) From Baseline [From Baseline to Day 421]
The results of the planned analysis related to mHTT protein levels in CSF are reported
- Mean Percentage Change in Ventricular Volume Boundary Shift Integral From Baseline to 15 Months [Baseline up to 15 months]
- Mean Percentage Change in Caudate Volume Boundary Shift Integral From Baseline to 15 Months [Baseline up to 15 months]
- Mean Percentage Change in Whole Brain Volume Boundary Shift Integral From Baseline to 15 Months [Baseline up to 15 months]
- EEG Parameters: Mean Change From Baseline to 15 Months in Absolute Power [8-12Hz] [Baseline to 15 Months]
- Mean Change From Baseline in Huntington's Disease Cognitive Assessment Battery Composite Score [Baseline to 15 Months]
HD Cognitive Assessment Battery (HD-CAB) was developed to assess cognitive dysfunction in late premanifest and early manifest HD patients. HD-CAB combines scores from six cognitive tests: SDMT, Self-Paced Tapping, Emotional Recognition, CANTAB One Touch Stocking, Hopkins Verbal Learning Test - Revised, and Trail-Making Test. A multi-component score is derived by transforming the subject's score on each cognitive test to a z-score. Using z-scores permits the combination of test scores with different scales. Unlike other measures that use an external reference population to create z-scores, HD-CAB uses the baseline data of the study. Individually, for each of the six cognitive tests, the study baseline mean is subtracted from the subject's score, and this value is divided by the study baseline standard deviation. The six z-scores are averaged to produce the HD-CAB score. A positive change from baseline indicates improvement in cognitive function; a negative change indicates worsening.
Eligibility Criteria
Criteria
Ages Eligible for Study:
25 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
- Must have completed dosing in ISIS 443139-CS1
Key Exclusion Criteria:
- Any new condition or worsening of existing condition that could make the patient unsuitable for participation or interfere with the patient participating in and/or completing the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of British Columbia; The Centre for Huntington Disease | Vancouver | British Columbia | Canada | V6T 2B5 |
| 2 | Charité - Universitätsmedizin Berlin, Campus Charité Mitte; Klinik für Psychiatrie und Psychotherapi | Berlin | Germany | 10117 | |
| 3 | St. Josef and St. Elisabeth GmbH ; Klinikum Bochum, Zentralapotheke | Bochum | Germany | 44791 | |
| 4 | Universitaetsklinikum Ulm | Ulm | Germany | 89081 | |
| 5 | NIHR Welcome Trust Birmingham CRF - University Hospitals Birmingham; Department of Neuropsychiatry | Birmingham | United Kingdom | B15 2FG | |
| 6 | University of Cambridge - John van Geest Centre for Brain Repair | Cambridge | United Kingdom | CB2 0PY | |
| 7 | Cardiff University School of Medicine; Institute of Psychological Medicine Clinical Neurosciences | Cardiff | United Kingdom | CF24 4HQ | |
| 8 | Leonard Wolfson Experimental Neurology Centre | London | United Kingdom | WC1N 3BG | |
| 9 | Central Manchester University Hospitals NHS Foundation Trust; Manchester Centre for Genomic Medicine | Manchester | United Kingdom | M13 9WL |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT03342053
Other Study ID Numbers:
- BN40697
First Posted:
Nov 14, 2017
Last Update Posted:
Mar 24, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participant eligibility for the study was determined within 4 weeks prior to participant entry into the Treatment Period. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | RO7234292 Monthly | RO7234292 Bimonthly |
|---|---|---|
| Arm/Group Description | RO7234292 was administered intrathecally every 28 days for 14 months. | RO7234292 was administered intrathecally every 56 days for 14 months following 2 monthly doses to serve as a loading dose. |
| Period Title: Overall Study | ||
| STARTED | 23 | 23 |
| COMPLETED | 21 | 22 |
| NOT COMPLETED | 2 | 1 |
Baseline Characteristics
| Arm/Group Title | RO7234292 Monthly | RO7234292 Bimonthly | Total |
|---|---|---|---|
| Arm/Group Description | RO7234292 was administered intrathecally every 28 days for 14 months. | RO7234292 was administered intrathecally every 56 days for 14 months following 2 monthly doses to serve as a loading dose. | Total of all reporting groups |
| Overall Participants | 23 | 23 | 46 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
23
100%
|
20
87%
|
43
93.5%
|
| >=65 years |
0
0%
|
3
13%
|
3
6.5%
|
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
47.7
(9.3)
|
49.5
(11.3)
|
48.6
(10.3)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
8
34.8%
|
10
43.5%
|
18
39.1%
|
| Male |
15
65.2%
|
13
56.5%
|
28
60.9%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
23
100%
|
23
100%
|
46
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
22
95.7%
|
23
100%
|
45
97.8%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Other |
1
4.3%
|
0
0%
|
1
2.2%
|
Outcome Measures
| Title | Percentage of Participants With Adverse Events |
|---|---|
| Description | Adverse Events include Adverse Events that started at or after Date/Time of First Exposure to Treatment and procedure-related Adverse Events occurring before the start of treatment. |
| Time Frame | From baseline up to 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population comprising all participants that were randomized and received at least one dose of RO7234292. |
| Arm/Group Title | RO7234292 Monthly | RO7234292 Bimonthly |
|---|---|---|
| Arm/Group Description | RO7234292 was administered intrathecally every 28 days for 14 months. | RO7234292 was administered intrathecally every 56 days for 14 months following 2 monthly doses to serve as a loading dose. |
| Measure Participants | 23 | 23 |
| Number [Percentage of participants] |
100
434.8%
|
95.7
416.1%
|
| Title | RO7234292 CSF Trough Concentrations by Study Day Prior to Monthly and Bimonthly IT Administration of 120 mg RO7234292 (Primary Analysis) |
|---|---|
| Description | |
| Time Frame | From baseline to Day 421 |
Outcome Measure Data
| Analysis Population Description |
|---|
| CSF Trough Concentrations were reported following study drug administration. Data for Bi-monthly arm was not collected on days 57, 113, 169, 225, 281, 337, 393. Here "Number Analyzed" represents number of participants from whom samples were collected and analyzed. |
| Arm/Group Title | RO7234292 Monthly | RO7234292 Bimonthly |
|---|---|---|
| Arm/Group Description | RO7234292 was administered intrathecally every 28 days for 14 months. | RO7234292 was administered intrathecally every 56 days for 14 months following 2 monthly doses to serve as a loading dose. |
| Measure Participants | 23 | 23 |
| Day 29 |
2.59
|
2.52
|
| Day 57 |
3.47
|
|
| Day 85 |
3.70
|
1.39
|
| Day 113 |
3.97
|
|
| Day 141 |
4.57
|
1.35
|
| Day 169 |
4.47
|
|
| Day 197 |
4.58
|
1.26
|
| Day 225 |
5.21
|
|
| Day 253 |
4.96
|
1.45
|
| Day 281 |
4.96
|
|
| Day 309 |
5.53
|
1.35
|
| Day 337 |
5.12
|
|
| Day 365 |
4.50
|
1.45
|
| Day 393 |
3.10
|
|
| Day 421 |
3.01
|
1.34
|
| Title | CSF mHTT Protein Concentration Logarithmic Value Change in Geometric Mean (95%CI) From Baseline |
|---|---|
| Description | The results of the planned analysis related to mHTT protein levels in CSF are reported |
| Time Frame | From Baseline to Day 421 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population. The data for Bi-monthly arm was not collected on days 113, 169, 225, 281, 337, 393. Here "Number Analyzed" represents number of participants from whom samples were collected and analyzed |
| Arm/Group Title | RO7234292 Monthly | RO7234292 Bimonthly |
|---|---|---|
| Arm/Group Description | RO7234292 was administered intrathecally every 28 days for 14 months. | RO7234292 was administered intrathecally every 56 days for 14 months following 2 monthly doses to serve as a loading dose. |
| Measure Participants | 23 | 23 |
| Day 29 |
-27.95
|
-21.84
|
| Day 57 |
-26.90
|
10.11
|
| Day 85 |
-50.30
|
-32.63
|
| Day 113 |
-49.11
|
|
| Day 141 |
-54.02
|
-41.76
|
| Day 169 |
-42.33
|
|
| Day 197 |
-40.79
|
-36.48
|
| Day 225 |
-47.01
|
|
| Day 253 |
-43.63
|
-41.06
|
| Day 281 |
-40.29
|
|
| Day 309 |
-36.67
|
-40.82
|
| Day 337 |
-42.71
|
|
| Day 365 |
-49.55
|
-55.07
|
| Day 393 |
-41.55
|
|
| Day 421 |
-45.45
|
-41.51
|
| Title | Mean Percentage Change in Ventricular Volume Boundary Shift Integral From Baseline to 15 Months |
|---|---|
| Description | |
| Time Frame | Baseline up to 15 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Here "Number of Participants Analyzed" represents number of participants from whom data were collected and analyzed. Only data that passed the QC imaging process were included in the analysis. |
| Arm/Group Title | RO7234292 Monthly | RO7234292 Bimonthly |
|---|---|---|
| Arm/Group Description | RO7234292 was administered intrathecally every 28 days for 14 months. | RO7234292 was administered intrathecally every 56 days for 14 months following 2 monthly doses to serve as a loading dose. |
| Measure Participants | 20 | 18 |
| Mean (Standard Deviation) [Percentage change] |
46.09
(32.14)
|
18.77
(10.36)
|
| Title | Mean Percentage Change in Caudate Volume Boundary Shift Integral From Baseline to 15 Months |
|---|---|
| Description | |
| Time Frame | Baseline up to 15 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Here "Number of Participants Analyzed" represents number of participants from whom data were collected and analyzed. |
| Arm/Group Title | RO7234292 Monthly | RO7234292 Bimonthly |
|---|---|---|
| Arm/Group Description | RO7234292 was administered intrathecally every 28 days for 14 months. | RO7234292 was administered intrathecally every 56 days for 14 months following 2 monthly doses to serve as a loading dose. |
| Measure Participants | 22 | 18 |
| Mean (Standard Deviation) [Percentage change] |
8.64
(6.26)
|
5.67
(2.22)
|
| Title | Mean Percentage Change in Whole Brain Volume Boundary Shift Integral From Baseline to 15 Months |
|---|---|
| Description | |
| Time Frame | Baseline up to 15 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Here "Number of Participants Analyzed" represents number of participants from whom data were collected and analyzed. |
| Arm/Group Title | RO7234292 Monthly | RO7234292 Bimonthly |
|---|---|---|
| Arm/Group Description | RO7234292 was administered intrathecally every 28 days for 14 months. | RO7234292 was administered intrathecally every 56 days for 14 months following 2 monthly doses to serve as a loading dose. |
| Measure Participants | 13 | 18 |
| Mean (Standard Deviation) [Percentage change] |
1.63
(1.41)
|
0.89
(0.92)
|
| Title | EEG Parameters: Mean Change From Baseline to 15 Months in Absolute Power [8-12Hz] |
|---|---|
| Description | |
| Time Frame | Baseline to 15 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | RO7234292 Monthly | RO7234292 Bimonthly |
|---|---|---|
| Arm/Group Description | RO7234292 was administered intrathecally every 28 days for 14 months. | RO7234292 was administered intrathecally every 56 days for 14 months following 2 monthly doses to serve as a loading dose. |
| Measure Participants | 17 | 19 |
| Mean (Standard Deviation) [log10(mircrovolts^2)] |
0.11
(0.18)
|
0.02
(0.21)
|
| Title | Mean Change From Baseline in Huntington's Disease Cognitive Assessment Battery Composite Score |
|---|---|
| Description | HD Cognitive Assessment Battery (HD-CAB) was developed to assess cognitive dysfunction in late premanifest and early manifest HD patients. HD-CAB combines scores from six cognitive tests: SDMT, Self-Paced Tapping, Emotional Recognition, CANTAB One Touch Stocking, Hopkins Verbal Learning Test - Revised, and Trail-Making Test. A multi-component score is derived by transforming the subject's score on each cognitive test to a z-score. Using z-scores permits the combination of test scores with different scales. Unlike other measures that use an external reference population to create z-scores, HD-CAB uses the baseline data of the study. Individually, for each of the six cognitive tests, the study baseline mean is subtracted from the subject's score, and this value is divided by the study baseline standard deviation. The six z-scores are averaged to produce the HD-CAB score. A positive change from baseline indicates improvement in cognitive function; a negative change indicates worsening. |
| Time Frame | Baseline to 15 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | RO7234292 Monthly | RO7234292 Bimonthly |
|---|---|---|
| Arm/Group Description | RO7234292 was administered intrathecally every 28 days for 14 months. | RO7234292 was administered intrathecally every 56 days for 14 months following 2 monthly doses to serve as a loading dose. |
| Measure Participants | 17 | 21 |
| Mean (Standard Deviation) [z-score] |
-0.33
(0.27)
|
-0.15
(0.23)
|
Adverse Events
| Time Frame | From baseline to up to 18 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Safety population comprising all participants that were randomized and received at least one dose of RO7234292 | |||
| Arm/Group Title | RO7234292 Monthly | RO7234292 Bimonthly | ||
| Arm/Group Description | RO7234292 was administered intrathecally every 28 days for 14 months. | RO7234292 was administered intrathecally every 56 days for 14 months following 2 monthly doses to serve as a loading dose. | ||
All Cause Mortality |
||||
| RO7234292 Monthly | RO7234292 Bimonthly | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/23 (4.3%) | 0/23 (0%) | ||
Serious Adverse Events |
||||
| RO7234292 Monthly | RO7234292 Bimonthly | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/23 (17.4%) | 3/23 (13%) | ||
| Infections and infestations | ||||
| Myelitis | 1/23 (4.3%) | 1 | 0/23 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Fall | 0/23 (0%) | 0 | 1/23 (4.3%) | 1 |
| Skin laceration | 0/23 (0%) | 0 | 1/23 (4.3%) | 1 |
| Cervical vertebral fracture | 0/23 (0%) | 0 | 1/23 (4.3%) | 1 |
| Chest injury | 1/23 (4.3%) | 1 | 0/23 (0%) | 0 |
| Concussion | 0/23 (0%) | 0 | 1/23 (4.3%) | 1 |
| Meningitis chemical | 1/23 (4.3%) | 1 | 0/23 (0%) | 0 |
| Rib fracture | 1/23 (4.3%) | 1 | 0/23 (0%) | 0 |
| Spinal column injury | 0/23 (0%) | 0 | 1/23 (4.3%) | 1 |
| Thoracic vertebral fracture | 1/23 (4.3%) | 1 | 0/23 (0%) | 0 |
| Nervous system disorders | ||||
| Cerebrovascular accident | 1/23 (4.3%) | 1 | 0/23 (0%) | 0 |
| Hemiparesis | 1/23 (4.3%) | 1 | 0/23 (0%) | 0 |
| Hydrocephalus | 1/23 (4.3%) | 1 | 0/23 (0%) | 0 |
| Hyporeflexia | 1/23 (4.3%) | 1 | 0/23 (0%) | 0 |
| Neuritis | 1/23 (4.3%) | 1 | 0/23 (0%) | 0 |
| Radiculopathy | 1/23 (4.3%) | 1 | 0/23 (0%) | 0 |
| Psychiatric disorders | ||||
| Completed suicide | 1/23 (4.3%) | 1 | 0/23 (0%) | 0 |
| Suicide attempt | 1/23 (4.3%) | 1 | 1/23 (4.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Pneumothorax | 1/23 (4.3%) | 1 | 0/23 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| RO7234292 Monthly | RO7234292 Bimonthly | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 22/23 (95.7%) | 22/23 (95.7%) | ||
| Ear and labyrinth disorders | ||||
| Vertigo | 2/23 (8.7%) | 2 | 0/23 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Diarrhoea | 0/23 (0%) | 0 | 5/23 (21.7%) | 6 |
| Nausea | 3/23 (13%) | 3 | 3/23 (13%) | 5 |
| Vomiting | 2/23 (8.7%) | 2 | 2/23 (8.7%) | 2 |
| General disorders | ||||
| Fatigue | 3/23 (13%) | 3 | 1/23 (4.3%) | 1 |
| Gait disturbance | 6/23 (26.1%) | 14 | 0/23 (0%) | 0 |
| Injection site pain | 2/23 (8.7%) | 3 | 4/23 (17.4%) | 4 |
| Puncture site pain | 2/23 (8.7%) | 3 | 2/23 (8.7%) | 4 |
| Infections and infestations | ||||
| Ear infection | 3/23 (13%) | 3 | 0/23 (0%) | 0 |
| Gastroenteritis | 2/23 (8.7%) | 2 | 1/23 (4.3%) | 1 |
| Nasopharyngitis | 9/23 (39.1%) | 14 | 10/23 (43.5%) | 15 |
| Upper respiratory tract infection | 3/23 (13%) | 4 | 1/23 (4.3%) | 2 |
| Urinary tract infection | 2/23 (8.7%) | 2 | 2/23 (8.7%) | 4 |
| Injury, poisoning and procedural complications | ||||
| Contusion | 6/23 (26.1%) | 21 | 5/23 (21.7%) | 5 |
| Fall | 18/23 (78.3%) | 87 | 12/23 (52.2%) | 17 |
| Head injury | 2/23 (8.7%) | 2 | 0/23 (0%) | 0 |
| Ligament sprain | 1/23 (4.3%) | 1 | 2/23 (8.7%) | 2 |
| Limb injury | 3/23 (13%) | 3 | 0/23 (0%) | 0 |
| Post lumbar puncture syndrome | 4/23 (17.4%) | 10 | 5/23 (21.7%) | 6 |
| Procedural headache | 0/23 (0%) | 0 | 2/23 (8.7%) | 4 |
| Procedural pain | 7/23 (30.4%) | 19 | 12/23 (52.2%) | 15 |
| Skin abrasion | 7/23 (30.4%) | 11 | 4/23 (17.4%) | 6 |
| Skin laceration | 2/23 (8.7%) | 2 | 3/23 (13%) | 3 |
| Investigations | ||||
| CSF protein increased | 2/23 (8.7%) | 3 | 1/23 (4.3%) | 1 |
| CSF white blood cell count increased | 2/23 (8.7%) | 2 | 0/23 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 3/23 (13%) | 4 | 2/23 (8.7%) | 2 |
| Back pain | 2/23 (8.7%) | 2 | 4/23 (17.4%) | 6 |
| Pain in extremity | 3/23 (13%) | 6 | 2/23 (8.7%) | 2 |
| Nervous system disorders | ||||
| Balance disorder | 3/23 (13%) | 3 | 1/23 (4.3%) | 1 |
| Cerebral ventricle dilatation | 2/23 (8.7%) | 2 | 0/23 (0%) | 0 |
| Dizziness | 2/23 (8.7%) | 2 | 2/23 (8.7%) | 2 |
| Dysarthria | 2/23 (8.7%) | 3 | 0/23 (0%) | 0 |
| Dyskinesia | 2/23 (8.7%) | 2 | 0/23 (0%) | 0 |
| Headache | 6/23 (26.1%) | 13 | 4/23 (17.4%) | 10 |
| Hyperkinesia | 2/23 (8.7%) | 2 | 0/23 (0%) | 0 |
| Lumbar radiculopathy | 2/23 (8.7%) | 2 | 0/23 (0%) | 0 |
| Motor dysfunction | 3/23 (13%) | 3 | 0/23 (0%) | 0 |
| Paraesthesia | 2/23 (8.7%) | 2 | 0/23 (0%) | 0 |
| Parkinsonism | 2/23 (8.7%) | 2 | 0/23 (0%) | 0 |
| Presyncope | 2/23 (8.7%) | 2 | 0/23 (0%) | 0 |
| Syncope | 0/23 (0%) | 0 | 2/23 (8.7%) | 2 |
| Psychiatric disorders | ||||
| Anxiety | 2/23 (8.7%) | 2 | 0/23 (0%) | 0 |
| Depressed mood | 2/23 (8.7%) | 2 | 2/23 (8.7%) | 2 |
| Depression | 4/23 (17.4%) | 4 | 2/23 (8.7%) | 2 |
| Insomnia | 1/23 (4.3%) | 1 | 2/23 (8.7%) | 2 |
| Irritability | 2/23 (8.7%) | 3 | 0/23 (0%) | 0 |
| Tension | 2/23 (8.7%) | 2 | 0/23 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 0/23 (0%) | 0 | 2/23 (8.7%) | 2 |
| Rhinorrhoea | 1/23 (4.3%) | 1 | 2/23 (8.7%) | 3 |
| Skin and subcutaneous tissue disorders | ||||
| Hyperhidrosis | 2/23 (8.7%) | 3 | 0/23 (0%) | 0 |
| Vascular disorders | ||||
| Haematoma | 4/23 (17.4%) | 7 | 2/23 (8.7%) | 2 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Medical Communications |
|---|---|
| Organization | Hoffmann-La Roche |
| Phone | 800 821-8590 |
| genentech@druginfo.com |
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT03342053
Other Study ID Numbers:
- BN40697
First Posted:
Nov 14, 2017
Last Update Posted:
Mar 24, 2022
Last Verified:
Mar 1, 2022