Trial Outcomes & Findings for Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity (NCT NCT04815967)
NCT ID: NCT04815967
Last Updated: 2026-05-27
Results Overview
The Modified Ashworth Scale (MAS) is an internationally accepted and validated instrument used to measure resistance during passive soft-tissue stretching. Resistance will be measured and recorded using a 6-point scale ranging from 0 (no increase in muscle tone) to 4 (affected part\[s\] rigid in flexion or extension). The post-injection MAS score is subtracted from the baseline MAS score to yield the change from baseline MAS score. A change from baseline MAS score \<0 represents a better outcome.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
32 participants
Primary outcome timeframe
Baseline and Week 4
Results posted on
2026-05-27
Participant Flow
The study was conducted at 10 sites located in the United States (4), Poland (6), and Hungary (1).
Participants were enrolled into the Phase 2 portion of study only. After participants completed the Double-Blind Phase (DBP; Treatment 1) of study, they can receive up to 4 treatments of MYOBLOC in the Open-Label Extension (OLE; Treatments 2-5). Since the Phase 2 portion of study did not complete target enrollment, there were no participants enrolled into the Phase 3 portion of study, which also included DBP portion followed by an OLE portion of study.
Participant milestones
| Measure |
Phase 2 (OLE); MYOBLOC (15,000-20,000 Units)
All participants receive MYOBLOC; up to 4 treatments every 13 weeks over a year (Treatments No. 2 to 5). All subjects will receive MYOBLOC 15,000 Units at Treatment 2 and, if demonstrated tolerability with 20,000 Units administered at a previous session, may receive MYOBLOC up to 20,000 Units for remaining Treatments 3 to 5.
|
Phase 2 (DBP); High Dose MYOBLOC (15,000 Units)
High Dose MYOBLOC (15,000 Units) is a single treatment and will be compared to volume-matched placebo
|
Phase 2 (DBP); Low Dose MYOBLOC (10,000 Units)
Low Dose MYOBLOC (10,000 Units) is a single treatment and will be compared to volume-matched placebo
|
Phase 2 (DBP); Placebo
Volume-matched placebo is a single treatment
|
|---|---|---|---|---|
|
Double-Blind Phase (DBP)
STARTED
|
0
|
10
|
11
|
11
|
|
Double-Blind Phase (DBP)
COMPLETED
|
0
|
7
|
10
|
7
|
|
Double-Blind Phase (DBP)
NOT COMPLETED
|
0
|
3
|
1
|
4
|
|
Open-Label Extension (OLE)
STARTED
|
24
|
0
|
0
|
0
|
|
Open-Label Extension (OLE)
COMPLETED
|
0
|
0
|
0
|
0
|
|
Open-Label Extension (OLE)
NOT COMPLETED
|
24
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase 2 (OLE); MYOBLOC (15,000-20,000 Units)
All participants receive MYOBLOC; up to 4 treatments every 13 weeks over a year (Treatments No. 2 to 5). All subjects will receive MYOBLOC 15,000 Units at Treatment 2 and, if demonstrated tolerability with 20,000 Units administered at a previous session, may receive MYOBLOC up to 20,000 Units for remaining Treatments 3 to 5.
|
Phase 2 (DBP); High Dose MYOBLOC (15,000 Units)
High Dose MYOBLOC (15,000 Units) is a single treatment and will be compared to volume-matched placebo
|
Phase 2 (DBP); Low Dose MYOBLOC (10,000 Units)
Low Dose MYOBLOC (10,000 Units) is a single treatment and will be compared to volume-matched placebo
|
Phase 2 (DBP); Placebo
Volume-matched placebo is a single treatment
|
|---|---|---|---|---|
|
Double-Blind Phase (DBP)
Study Terminated by Sponsor
|
0
|
2
|
1
|
4
|
|
Double-Blind Phase (DBP)
Slow vital capacity <60% of predicted
|
0
|
1
|
0
|
0
|
|
Open-Label Extension (OLE)
Study Terminated by Sponsor
|
24
|
0
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity
Baseline characteristics by cohort
| Measure |
Phase 2 (DBP); High Dose MYOBLOC (15,000 Units)
n=10 Participants
High Dose MYOBLOC (15,000 Units) is a single treatment and will be compared to volume-matched placebo
|
Phase 2 (DBP); Low Dose MYOBLOC (10,000 Units)
n=11 Participants
Low Dose MYOBLOC (10,000 Units) is a single treatment and will be compared to volume-matched placebo
|
Phase 2 (DBP); Placebo
n=11 Participants
Volume-matched placebo is a single treatment
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=51 Participants
|
8 Participants
n=14 Participants
|
9 Participants
n=65 Participants
|
25 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=51 Participants
|
3 Participants
n=14 Participants
|
2 Participants
n=65 Participants
|
7 Participants
n=24 Participants
|
|
Age, Continuous
|
51.4 years
STANDARD_DEVIATION 14.18 • n=51 Participants
|
52.8 years
STANDARD_DEVIATION 13.07 • n=14 Participants
|
53.8 years
STANDARD_DEVIATION 10.22 • n=65 Participants
|
52.7 years
STANDARD_DEVIATION 12.17 • n=24 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=51 Participants
|
5 Participants
n=14 Participants
|
4 Participants
n=65 Participants
|
14 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=51 Participants
|
6 Participants
n=14 Participants
|
7 Participants
n=65 Participants
|
18 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=51 Participants
|
3 Participants
n=14 Participants
|
4 Participants
n=65 Participants
|
7 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=51 Participants
|
8 Participants
n=14 Participants
|
7 Participants
n=65 Participants
|
25 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=51 Participants
|
11 Participants
n=14 Participants
|
11 Participants
n=65 Participants
|
30 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=51 Participants
|
4 participants
n=14 Participants
|
6 participants
n=65 Participants
|
12 participants
n=24 Participants
|
|
Region of Enrollment
Poland
|
7 participants
n=51 Participants
|
7 participants
n=14 Participants
|
5 participants
n=65 Participants
|
19 participants
n=24 Participants
|
|
Region of Enrollment
Hungary
|
1 participants
n=51 Participants
|
0 participants
n=14 Participants
|
0 participants
n=65 Participants
|
1 participants
n=24 Participants
|
|
Primary Target Muscle Group (PTMG)
Elbow Flexors
|
6 Participants
n=51 Participants
|
6 Participants
n=14 Participants
|
6 Participants
n=65 Participants
|
18 Participants
n=24 Participants
|
|
Primary Target Muscle Group (PTMG)
Wrist Flexors
|
1 Participants
n=51 Participants
|
1 Participants
n=14 Participants
|
2 Participants
n=65 Participants
|
4 Participants
n=24 Participants
|
|
Primary Target Muscle Group (PTMG)
Finger Flexors
|
3 Participants
n=51 Participants
|
4 Participants
n=14 Participants
|
3 Participants
n=65 Participants
|
10 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: Modified Intent-to-Treat (MITT) Population, defined as all subjects who are injected with study drug, have a valid Modified Ashworth Scale (MAS) score at Baseline (Day 1) visit and at least one valid MAS score and valid Clinical Global Impression of Change (CGI-C) score at the Week 4 post-baseline visit in the Double-Blind Phase of the study.
The Modified Ashworth Scale (MAS) is an internationally accepted and validated instrument used to measure resistance during passive soft-tissue stretching. Resistance will be measured and recorded using a 6-point scale ranging from 0 (no increase in muscle tone) to 4 (affected part\[s\] rigid in flexion or extension). The post-injection MAS score is subtracted from the baseline MAS score to yield the change from baseline MAS score. A change from baseline MAS score \<0 represents a better outcome.
Outcome measures
| Measure |
Phase 2 (DBP); High Dose MYOBLOC (15,000 Units)
n=10 Participants
High Dose MYOBLOC (15,000 Units) is a single treatment and will be compared to volume-matched placebo
|
Phase 2 (DBP); Low Dose MYOBLOC (10,000 Units)
n=11 Participants
Low Dose MYOBLOC (10,000 Units) is a single treatment and will be compared to volume-matched placebo
|
Phase 2 (DBP); Placebo
n=11 Participants
Volume-matched placebo is a single treatment
|
|---|---|---|---|
|
The Change From Baseline in Modified Ashworth Scale (MAS) Score for Tone of the Primary Target Muscle Group (PTMG) Selected for Treatment at Week 4 Post-injection.
Baseline; absolute score
|
2.90 units on a scale
Standard Deviation 0.568
|
2.82 units on a scale
Standard Deviation 0.405
|
2.73 units on a scale
Standard Deviation 0.467
|
|
The Change From Baseline in Modified Ashworth Scale (MAS) Score for Tone of the Primary Target Muscle Group (PTMG) Selected for Treatment at Week 4 Post-injection.
Week 4; absolute score
|
2.05 units on a scale
Standard Deviation 0.762
|
1.82 units on a scale
Standard Deviation 0.681
|
2.65 units on a scale
Standard Deviation 0.580
|
|
The Change From Baseline in Modified Ashworth Scale (MAS) Score for Tone of the Primary Target Muscle Group (PTMG) Selected for Treatment at Week 4 Post-injection.
Week 4; change from baseline score
|
-0.85 units on a scale
Standard Deviation 0.474
|
-1.00 units on a scale
Standard Deviation 0.632
|
-0.05 units on a scale
Standard Deviation 0.497
|
PRIMARY outcome
Timeframe: Week 4Population: Modified Intent-to-Treat (MITT) Population, defined as all subjects who are injected with study drug, have a valid Modified Ashworth Scale (MAS) score at Baseline (Day 1) visit and at least one valid MAS score and valid Clinical Global Impression of Change (CGI-C) score at the Week 4 post-baseline visit in the Double-Blind Phase (DBP) of the study.
The Clinical Global Impression of Change (CGI-C) scale is a single item clinician assessment of how much the patient's functional ability has improved, worsened or has not changed relative to the patient's baseline state prior to treatment (injection). The CGI-C is rated on a 7-point Likert scale from 1 to 7, where 1 = "Very much improved", 2 = "Much improved", 3 = "Minimally improved", 4 = "No change", 5 = "Minimally worse", 6 = "Much worse", and 7 = "Very much worse". A CGI-C score \<4 represents a better outcome.
Outcome measures
| Measure |
Phase 2 (DBP); High Dose MYOBLOC (15,000 Units)
n=10 Participants
High Dose MYOBLOC (15,000 Units) is a single treatment and will be compared to volume-matched placebo
|
Phase 2 (DBP); Low Dose MYOBLOC (10,000 Units)
n=11 Participants
Low Dose MYOBLOC (10,000 Units) is a single treatment and will be compared to volume-matched placebo
|
Phase 2 (DBP); Placebo
n=11 Participants
Volume-matched placebo is a single treatment
|
|---|---|---|---|
|
The Clinical Global Impression of Change (CGI-C) Score in Functional Ability at Week 4 Post-injection.
|
2.4 score on a scale
Standard Deviation 0.70
|
2.6 score on a scale
Standard Deviation 0.67
|
3.3 score on a scale
Standard Deviation 0.48
|
Adverse Events
Phase 2 (DBP); High Dose MYOBLOC (15,000 Units)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 2 (DBP); Low Dose MYOBLOC (10,000 Units)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 2 (DBP); Placebo
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase 2 (OLE); MYOBLOC (15,000-20,000 Units)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 2 (DBP); High Dose MYOBLOC (15,000 Units)
n=10 participants at risk
High Dose MYOBLOC (15,000 Units) is a single treatment and will be compared to volume-matched placebo
|
Phase 2 (DBP); Low Dose MYOBLOC (10,000 Units)
n=11 participants at risk
Low Dose MYOBLOC (10,000 Units) is a single treatment and will be compared to volume-matched placebo
|
Phase 2 (DBP); Placebo
n=11 participants at risk
Volume-matched placebo is a single treatment
|
Phase 2 (OLE); MYOBLOC (15,000-20,000 Units)
n=24 participants at risk
All participants receive MYOBLOC; up to 4 treatments every 13 weeks over a year (Treatments No. 2 to 5). All subjects will receive MYOBLOC 15,000 Units at Treatment 2 and may receive MYOBLOC up to 20,000 Units for remaining Treatments 3 to 5.
|
|---|---|---|---|---|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/10 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
9.1%
1/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/24 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
Other adverse events
| Measure |
Phase 2 (DBP); High Dose MYOBLOC (15,000 Units)
n=10 participants at risk
High Dose MYOBLOC (15,000 Units) is a single treatment and will be compared to volume-matched placebo
|
Phase 2 (DBP); Low Dose MYOBLOC (10,000 Units)
n=11 participants at risk
Low Dose MYOBLOC (10,000 Units) is a single treatment and will be compared to volume-matched placebo
|
Phase 2 (DBP); Placebo
n=11 participants at risk
Volume-matched placebo is a single treatment
|
Phase 2 (OLE); MYOBLOC (15,000-20,000 Units)
n=24 participants at risk
All participants receive MYOBLOC; up to 4 treatments every 13 weeks over a year (Treatments No. 2 to 5). All subjects will receive MYOBLOC 15,000 Units at Treatment 2 and may receive MYOBLOC up to 20,000 Units for remaining Treatments 3 to 5.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
2/10 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
4.2%
1/24 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
|
Gastrointestinal disorders
Dysphagia
|
10.0%
1/10 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/24 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
9.1%
1/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/24 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/24 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
8.3%
2/24 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
|
Infections and infestations
Erysipelas
|
0.00%
0/10 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
9.1%
1/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/24 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
9.1%
1/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
4.2%
1/24 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
|
Eye disorders
Vision blurred
|
10.0%
1/10 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
4.2%
1/24 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
|
General disorders
Fatigue
|
10.0%
1/10 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/24 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/10 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
9.1%
1/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/24 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
|
Investigations
Weight increased
|
0.00%
0/10 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
9.1%
1/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/24 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
|
Vascular disorders
Hypertension
|
0.00%
0/10 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
9.1%
1/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/24 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
|
Nervous system disorders
Hyperreflexia
|
0.00%
0/10 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
9.1%
1/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/24 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
|
Renal and urinary disorders
Urinary tract inflammation
|
0.00%
0/10 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
9.1%
1/11 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
0.00%
0/24 • Double-Blind Phase (DBP) is up to 13 Weeks post-injections (one treatment; Treatment 1); Open-label Extension is up to 52 Weeks (4 treatments of MYOBLOC once every 13 weeks; Treatments 2-5)
During the Open-label Extension period participants received between 15,000 and 20,000 units of MYOBLOC. Adverse events during the Open-label Extension period are reported for overall Safety Population (participants who received at least one injection of MYOBLOC).
|
Additional Information
Head of Clinical Development
Supernus Pharmaceuticals Inc.
Phone: 301-838-2500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place