Trial Outcomes & Findings for Open-label Extension Study to Evaluate the Safety and Tolerability of WVE-120102 in Patients With Huntington's Disease (NCT NCT04617860)
NCT ID: NCT04617860
Last Updated: 2022-02-09
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Day 1 to Study Termination (maximum of 12 monthly doses)
Results posted on
2022-02-09
Participant Flow
In the original OLE study protocol, patients who were in the 2 and 4 mg dose cohorts in the Phase 1b/2a study were to be enrolled into the 4 or 8 mg dose group in this study. Patients in the 8 and 16 mg dose cohorts in WVE-HDSNP1-001 continued to receive that dose. As of Amendment 2.0 of this protocol, all new patients were to be enrolled at a dose level of at least 16 mg. All current patents were dose modified to 16 or 32 mg.
Participant milestones
| Measure |
4 mg WVE-120102
Enrolled at 4 mg WVE-120102 dose level
|
8 mg WVE-120102
Enrolled at 8 mg WVE-120102 dose level
|
16 mg WVE-120102
Enrolled at 16 mg WVE-120102 dose level
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
10
|
18
|
|
Overall Study
Dose Modified to 8 mg
|
8
|
1
|
0
|
|
Overall Study
Dose Modified to 16 mg
|
8
|
9
|
8
|
|
Overall Study
Dose Modified to 32 mg
|
2
|
4
|
11
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
18
|
Reasons for withdrawal
| Measure |
4 mg WVE-120102
Enrolled at 4 mg WVE-120102 dose level
|
8 mg WVE-120102
Enrolled at 8 mg WVE-120102 dose level
|
16 mg WVE-120102
Enrolled at 16 mg WVE-120102 dose level
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
|
Overall Study
Sponsor Decision
|
0
|
3
|
1
|
|
Overall Study
Termination of Study by Sponsor
|
8
|
4
|
13
|
Baseline Characteristics
Open-label Extension Study to Evaluate the Safety and Tolerability of WVE-120102 in Patients With Huntington's Disease
Baseline characteristics by cohort
| Measure |
4 mg WVE-120102
n=8 Participants
Enrolled at 4 mg WVE-120102 dose level
|
8 mg WVE-120102
n=10 Participants
Enrolled at 8 mg WVE-120102 dose level
|
16 mg WVE-120102
n=18 Participants
Enrolled at 16 mg WVE-120102 dose level
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
36 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
36 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
Canada
|
8 participants
n=99 Participants
|
1 participants
n=107 Participants
|
12 participants
n=206 Participants
|
21 participants
n=7 Participants
|
|
Region of Enrollment
Denmark
|
0 participants
n=99 Participants
|
5 participants
n=107 Participants
|
0 participants
n=206 Participants
|
5 participants
n=7 Participants
|
|
Region of Enrollment
Poland
|
0 participants
n=99 Participants
|
4 participants
n=107 Participants
|
5 participants
n=206 Participants
|
9 participants
n=7 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
1 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Study Termination (maximum of 12 monthly doses)Population: Patients treated at more than one dose level (e.g., initial dose and after dose modification) are included in each applicable dose group. Adverse events are counted in the dose the patient was receiving at the time of onset.
Outcome measures
| Measure |
4 mg WVE-120102
n=8 Participants
Received 4 mg WVE-120102 at any point in the study
|
8 mg WVE-120102
n=18 Participants
Received 8 mg WVE-120102 at any point in the study
|
16 mg WVE-120102
n=35 Participants
Received 16 mg WVE-120102 at any point in the study
|
32 mg WVE-120102
n=17 Participants
Received 32 mg WVE-120102 at any point in the study
|
|---|---|---|---|---|
|
Safety: Number of Patients With Treatment-emergent Adverse Events (TEAEs)
|
7 Participants
|
14 Participants
|
34 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Study Termination (maximum of 12 monthly doses)Population: Patients treated at more than one dose level (e.g., initial dose and after dose modification) are included in each applicable dose group. Adverse events are counted in the dose the patient was receiving at the time of onset.
Outcome measures
| Measure |
4 mg WVE-120102
n=8 Participants
Received 4 mg WVE-120102 at any point in the study
|
8 mg WVE-120102
n=18 Participants
Received 8 mg WVE-120102 at any point in the study
|
16 mg WVE-120102
n=35 Participants
Received 16 mg WVE-120102 at any point in the study
|
32 mg WVE-120102
n=17 Participants
Received 32 mg WVE-120102 at any point in the study
|
|---|---|---|---|---|
|
Safety: Number of Patients With a Severe TEAE
|
0 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Study Termination (maximum of 12 monthly doses)Population: Patients treated at more than one dose level (e.g. initial dose and after dose modification) are included in each applicable dose group. Adverse events are counted in the dose the patient was receiving at the time of onset.
Outcome measures
| Measure |
4 mg WVE-120102
n=8 Participants
Received 4 mg WVE-120102 at any point in the study
|
8 mg WVE-120102
n=18 Participants
Received 8 mg WVE-120102 at any point in the study
|
16 mg WVE-120102
n=35 Participants
Received 16 mg WVE-120102 at any point in the study
|
32 mg WVE-120102
n=17 Participants
Received 32 mg WVE-120102 at any point in the study
|
|---|---|---|---|---|
|
Safety: Number of Patients With Serious TEAEs
|
0 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Study Termination (maximum of 12 monthly doses)Population: Patients treated at more than one dose level (e.g., initial dose and after dose modification) are included in each applicable dose group. Adverse events are counted in the dose the patient was receiving at the time of onset.
Outcome measures
| Measure |
4 mg WVE-120102
n=8 Participants
Received 4 mg WVE-120102 at any point in the study
|
8 mg WVE-120102
n=18 Participants
Received 8 mg WVE-120102 at any point in the study
|
16 mg WVE-120102
n=35 Participants
Received 16 mg WVE-120102 at any point in the study
|
32 mg WVE-120102
n=17 Participants
Received 32 mg WVE-120102 at any point in the study
|
|---|---|---|---|---|
|
Safety and Tolerability: Number of Patients Who Withdraw Due to TEAEs
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
Adverse Events
4 mg WVE-120102
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
8 mg WVE-120102
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
16 mg WVE-120102
Serious events: 5 serious events
Other events: 34 other events
Deaths: 0 deaths
32 mg WVE-120102
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
4 mg WVE-120102
n=8 participants at risk
Received 4 mg WVE-120102 at any point in the study
|
8 mg WVE-120102
n=18 participants at risk
Received 8 mg WVE-120102 at any point in the study
|
16 mg WVE-120102
n=35 participants at risk
Received 16 mg WVE-120102 at any point in the study
|
32 mg WVE-120102
n=17 participants at risk
Received 32 mg WVE-120102 at any point in the study
|
|---|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
2.9%
1/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Infections and infestations
Meningitis
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.6%
1/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
2.9%
1/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Infections and infestations
Meningitis asceptic
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.7%
2/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
11.8%
2/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Nervous system disorders
Amnesia
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
11.8%
2/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.9%
1/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Psychiatric disorders
Aggression
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
2.9%
1/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Psychiatric disorders
Agitation
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.9%
1/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
Other adverse events
| Measure |
4 mg WVE-120102
n=8 participants at risk
Received 4 mg WVE-120102 at any point in the study
|
8 mg WVE-120102
n=18 participants at risk
Received 8 mg WVE-120102 at any point in the study
|
16 mg WVE-120102
n=35 participants at risk
Received 16 mg WVE-120102 at any point in the study
|
32 mg WVE-120102
n=17 participants at risk
Received 32 mg WVE-120102 at any point in the study
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.9%
1/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
8.6%
3/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
11.8%
2/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
8.6%
3/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
1/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Gastrointestinal disorders
Paresthesia oral
|
12.5%
1/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
General disorders
Pyrexia
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
17.1%
6/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
11.8%
2/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
General disorders
Fatigue
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
17.1%
6/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
23.5%
4/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
General disorders
Pain
|
12.5%
1/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
8.6%
3/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.9%
1/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
General disorders
Gait disturbance
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.7%
2/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.9%
1/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
General disorders
Injection site erythema
|
12.5%
1/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
General disorders
Injection site hypersensitivity
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.9%
1/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.7%
2/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Infections and infestations
Cystitis
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.6%
1/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.6%
1/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
1/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.6%
1/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
2/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
16.7%
3/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
14.3%
5/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
11.8%
2/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
25.0%
2/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
11.4%
4/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
11.8%
2/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Injury, poisoning and procedural complications
Procedural headache
|
12.5%
1/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.7%
2/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Injury, poisoning and procedural complications
Skin laceration
|
12.5%
1/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
2.9%
1/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Injury, poisoning and procedural complications
Contusion
|
12.5%
1/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.6%
1/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
12.5%
1/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.6%
1/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Investigations
CSF protein increased
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
16.7%
3/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
20.0%
7/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
23.5%
4/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Investigations
CSF lymphocyte count increased
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
11.1%
2/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
14.3%
5/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Investigations
CSF test abnormal
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
17.6%
3/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.6%
1/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.9%
1/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Investigations
CSF white blood cell count
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.7%
2/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.7%
2/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Investigations
Complement factor increased
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.9%
1/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Investigations
Dermatologic examination abnormal
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.9%
1/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Investigations
Neurological examination abnormal
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.9%
1/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
2.9%
1/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.9%
1/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.9%
1/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.9%
1/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.6%
1/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
17.1%
6/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
29.4%
5/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
14.3%
5/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
11.8%
2/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.7%
2/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
17.6%
3/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
2.9%
1/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
11.8%
2/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.7%
2/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.9%
1/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
33.3%
6/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
40.0%
14/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
35.3%
6/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
11.4%
4/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
17.6%
3/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Nervous system disorders
Amnesia
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.9%
1/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Nervous system disorders
Ataxia
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
17.6%
3/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
11.8%
2/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Nervous system disorders
Dyskinesia
|
12.5%
1/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
2.9%
1/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.7%
2/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Nervous system disorders
Presyncope
|
12.5%
1/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.9%
1/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
11.8%
2/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.6%
1/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.9%
1/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.9%
1/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Nervous system disorders
Migraine
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.9%
1/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
8.6%
3/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
29.4%
5/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Psychiatric disorders
Apathy
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.6%
1/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
2.9%
1/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Psychiatric disorders
Behavior disorder
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.7%
2/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.6%
1/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
2.9%
1/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Psychiatric disorders
Irritability
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
11.1%
2/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.9%
1/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.7%
2/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.6%
1/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.9%
1/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Psychiatric disorders
Persecutory delusion
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.6%
1/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.9%
1/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.6%
1/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.6%
1/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
8.6%
3/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.6%
1/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Respiratory, thoracic and mediastinal disorders
Dysnpoea
|
12.5%
1/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.6%
1/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
|
Vascular disorders
Hypotension
|
0.00%
0/8 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/18 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
0.00%
0/35 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
5.9%
1/17 • Day 1 to Study Termination (maximum of 12 monthly doses)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place