Trial Outcomes & Findings for Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Lower Limb Spasticity (NCT NCT04099667)

Last Updated: 2026-05-22

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

40 participants

Primary outcome timeframe

Baseline and Week 4

Results posted on

2026-05-22

Participant Flow

The study was conducted at 9 sites located in the United States (4), Poland (4), and Hungary (1).

Participants were enrolled into the Phase 2 portion of study only. After participants who complete the Double-Blind Phase (DBP; Treatment 1) of study 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 would have also included a DBP portion followed by an OLE portion of study.

Participant milestones

Participant milestones
Measure	Phase 2 (DBP); High Dose MYOBLOC (20,000 Units) High Dose MYOBLOC (20,000 Units) is a single treatment and will be compared to volume-matched placebo	Phase 2 (DBP); Low Dose MYOBLOC (15,000 Units) Low Dose MYOBLOC (15,000 Units) is a single treatment and will be compared to volume-matched placebo	Phase 2 (DBP); Placebo Volume-matched placebo is a single treatment	Phase 2 (OLE); MYOBLOC (20,000-25,000 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 20,000 Units at Treatment 2 and, if demonstrated tolerability with 20,000 Units administered at a previous session, may receive MYOBLOC up to 25,000 Units for remaining Treatments 3 to 5.
Double-Blind Phase (DBP) STARTED	14	14	12	0
Double-Blind Phase (DBP) COMPLETED	13	13	12	0
Double-Blind Phase (DBP) NOT COMPLETED	1	1	0	0
Open-Label Extension (OLE) STARTED	0	0	0	37
Open-Label Extension (OLE) COMPLETED	0	0	0	8
Open-Label Extension (OLE) NOT COMPLETED	0	0	0	29

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 2 (DBP); High Dose MYOBLOC (20,000 Units) High Dose MYOBLOC (20,000 Units) is a single treatment and will be compared to volume-matched placebo	Phase 2 (DBP); Low Dose MYOBLOC (15,000 Units) Low Dose MYOBLOC (15,000 Units) is a single treatment and will be compared to volume-matched placebo	Phase 2 (OLE); MYOBLOC (20,000-25,000 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 20,000 Units at Treatment 2 and, if demonstrated tolerability with 20,000 Units administered at a previous session, may receive MYOBLOC up to 25,000 Units for remaining Treatments 3 to 5.
Double-Blind Phase (DBP) Adverse Event	0	1	0
Double-Blind Phase (DBP) Study Terminated by Sponsor	1	0	0
Open-Label Extension (OLE) Adverse Event	0	0	2
Open-Label Extension (OLE) Lack of Efficacy	0	0	1
Open-Label Extension (OLE) Withdrawal by Subject	0	0	1
Open-Label Extension (OLE) Study Terminated by Sponsor	0	0	25

Baseline Characteristics

Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Lower Limb Spasticity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 2 (DBP); High Dose MYOBLOC (20,000 Units) n=14 Participants High Dose MYOBLOC (20,000 Units) is a single treatment and will be compared to volume-matched placebo	Phase 2 (DBP); Low Dose MYOBLOC (15,000 Units) n=14 Participants Low Dose MYOBLOC (15,000 Units) is a single treatment and will be compared to volume-matched placebo	Phase 2 (DBP); Placebo n=12 Participants Volume-matched placebo is a single treatment	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=2 Participants	11 Participants n=4 Participants	7 Participants n=6 Participants	31 Participants n=8 Participants
Age, Categorical >=65 years	1 Participants n=2 Participants	3 Participants n=4 Participants	5 Participants n=6 Participants	9 Participants n=8 Participants
Age, Continuous	49.1 years STANDARD_DEVIATION 12.42 • n=2 Participants	53.1 years STANDARD_DEVIATION 13.84 • n=4 Participants	57.1 years STANDARD_DEVIATION 14.36 • n=6 Participants	52.9 years STANDARD_DEVIATION 13.56 • n=8 Participants
Sex: Female, Male Female	2 Participants n=2 Participants	9 Participants n=4 Participants	2 Participants n=6 Participants	13 Participants n=8 Participants
Sex: Female, Male Male	12 Participants n=2 Participants	5 Participants n=4 Participants	10 Participants n=6 Participants	27 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=2 Participants	1 Participants n=4 Participants	3 Participants n=6 Participants	6 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=2 Participants	13 Participants n=4 Participants	9 Participants n=6 Participants	34 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	2 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	2 Participants n=8 Participants
Race (NIH/OMB) White	12 Participants n=2 Participants	14 Participants n=4 Participants	12 Participants n=6 Participants	38 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants
Region of Enrollment United States	7 participants n=2 Participants	5 participants n=4 Participants	6 participants n=6 Participants	18 participants n=8 Participants
Region of Enrollment Poland	7 participants n=2 Participants	8 participants n=4 Participants	6 participants n=6 Participants	21 participants n=8 Participants
Region of Enrollment Hungary	0 participants n=2 Participants	1 participants n=4 Participants	0 participants n=6 Participants	1 participants n=8 Participants
Modified Ashworth Scale (MAS) score of the Gastrocnemius/Soleus Complex [Ankle Plantar Flexors]	2.71 units on a scale STANDARD_DEVIATION 0.469 • n=2 Participants	2.50 units on a scale STANDARD_DEVIATION 0.519 • n=4 Participants	2.67 units on a scale STANDARD_DEVIATION 0.651 • n=6 Participants	2.63 units on a scale STANDARD_DEVIATION 0.540 • n=8 Participants

PRIMARY outcome

Timeframe: Baseline and Week 4

Population: 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.

Outcome measures

Outcome measures
Measure	Phase 2 (DBP); High Dose MYOBLOC (20,000 Units) n=14 Participants High Dose MYOBLOC (20,000 Units) is a single treatment and will be compared to volume-matched placebo	Phase 2 (DBP); Low Dose MYOBLOC (15,000 Units) n=14 Participants Low Dose MYOBLOC (15,000 Units) is a single treatment and will be compared to volume-matched placebo	Phase 2 (DBP); Placebo n=12 Participants Volume-matched placebo is a single treatment
The Change From Baseline in the Modified Ashworth Scale (MAS) Score in the Tone of the Ankle Plantar Flexors at Week 4 Post-injection. Baseline; absolute score	2.71 units on a scale Standard Deviation 0.469	2.50 units on a scale Standard Deviation 0.519	2.67 units on a scale Standard Deviation 0.651
The Change From Baseline in the Modified Ashworth Scale (MAS) Score in the Tone of the Ankle Plantar Flexors at Week 4 Post-injection. Week 4; absolute score	2.00 units on a scale Standard Deviation 0.650	1.85 units on a scale Standard Deviation 0.516	2.04 units on a scale Standard Deviation 0.782
The Change From Baseline in the Modified Ashworth Scale (MAS) Score in the Tone of the Ankle Plantar Flexors at Week 4 Post-injection. Week 4; change from baseline score	-0.71 units on a scale Standard Deviation 0.642	-0.62 units on a scale Standard Deviation 0.546	-0.63 units on a scale Standard Deviation 0.608

PRIMARY outcome

Timeframe: Week 4

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

Outcome measures
Measure	Phase 2 (DBP); High Dose MYOBLOC (20,000 Units) n=14 Participants High Dose MYOBLOC (20,000 Units) is a single treatment and will be compared to volume-matched placebo	Phase 2 (DBP); Low Dose MYOBLOC (15,000 Units) n=14 Participants Low Dose MYOBLOC (15,000 Units) is a single treatment and will be compared to volume-matched placebo	Phase 2 (DBP); Placebo n=12 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	2.9 units on a scale Standard Deviation 0.83	3.1 units on a scale Standard Deviation 0.66	3.2 units on a scale Standard Deviation 0.98

Adverse Events

Phase 2 (DBP); High Dose MYOBLOC (20,000 Units)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Phase 2 (DBP); Low Dose MYOBLOC (15,000 Units)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Phase 2 (DBP); Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Phase 2 (OLE); MYOBLOC (20,000-25,000 Units)

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Phase 2 (DBP); High Dose MYOBLOC (20,000 Units) n=14 participants at risk High Dose MYOBLOC (20,000 Units) is a single treatment and will be compared to volume-matched placebo	Phase 2 (DBP); Low Dose MYOBLOC (15,000 Units) n=14 participants at risk Low Dose MYOBLOC (15,000 Units) is a single treatment and will be compared to volume-matched placebo	Phase 2 (DBP); Placebo n=12 participants at risk Volume-matched placebo is a single treatment	Phase 2 (OLE); MYOBLOC (20,000-25,000 Units) n=37 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 20,000 Units at Treatment 2 and, if demonstrated tolerability with 20,000 Units administered at a previous session, may receive MYOBLOC up to 25,000 Units for remaining Treatments 3 to 5.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal Cancer	0.00% 0/14 • 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)	0.00% 0/14 • 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)	0.00% 0/12 • 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)	2.7% 1/37 • 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)
Renal and urinary disorders Ureterolithiasis	0.00% 0/14 • 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)	0.00% 0/14 • 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)	0.00% 0/12 • 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)	2.7% 1/37 • 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)
Vascular disorders Shock	0.00% 0/14 • 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)	0.00% 0/14 • 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)	0.00% 0/12 • 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)	2.7% 1/37 • 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)

Other adverse events

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

Restriction type: OTHER

Measure	Phase 2 (DBP); High Dose MYOBLOC (20,000 Units) n=14 participants at risk High Dose MYOBLOC (20,000 Units) is a single treatment and will be compared to volume-matched placebo	Phase 2 (DBP); Low Dose MYOBLOC (15,000 Units) n=14 participants at risk Low Dose MYOBLOC (15,000 Units) is a single treatment and will be compared to volume-matched placebo	Phase 2 (DBP); Placebo n=12 participants at risk Volume-matched placebo is a single treatment	Phase 2 (OLE); MYOBLOC (20,000-25,000 Units) n=37 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 20,000 Units at Treatment 2 and, if demonstrated tolerability with 20,000 Units administered at a previous session, may receive MYOBLOC up to 25,000 Units for remaining Treatments 3 to 5.
Infections and infestations Hordeolum	7.1% 1/14 • 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)	0.00% 0/14 • 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)	0.00% 0/12 • 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)	0.00% 0/37 • 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)
Infections and infestations Nasopharyngitis	7.1% 1/14 • 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)	0.00% 0/14 • 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)	0.00% 0/12 • 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)	0.00% 0/37 • 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)
Gastrointestinal disorders Dry mouth	7.1% 1/14 • 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)	7.1% 1/14 • 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)	0.00% 0/12 • 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)	5.4% 2/37 • 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)
Investigations Blood cholesterol increased	7.1% 1/14 • 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)	0.00% 0/14 • 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)	0.00% 0/12 • 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)	2.7% 1/37 • 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)
Investigations Blood urine present	0.00% 0/14 • 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)	7.1% 1/14 • 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)	0.00% 0/12 • 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)	0.00% 0/37 • 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)
Investigations Urine leukocyte esterase	0.00% 0/14 • 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)	7.1% 1/14 • 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)	0.00% 0/12 • 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)	0.00% 0/37 • 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)
Investigations Blood potassium increased	0.00% 0/14 • 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)	0.00% 0/14 • 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)	8.3% 1/12 • 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)	0.00% 0/37 • 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)
Nervous system disorders Headache	7.1% 1/14 • 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)	0.00% 0/14 • 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)	0.00% 0/12 • 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)	0.00% 0/37 • 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)
Nervous system disorders Neuralgia	7.1% 1/14 • 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)	0.00% 0/14 • 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)	0.00% 0/12 • 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)	0.00% 0/37 • 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)
Injury, poisoning and procedural complications Fall	0.00% 0/14 • 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)	7.1% 1/14 • 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)	0.00% 0/12 • 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)	2.7% 1/37 • 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)
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/14 • 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)	7.1% 1/14 • 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)	0.00% 0/12 • 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)	0.00% 0/37 • 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)
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/14 • 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)	7.1% 1/14 • 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)	0.00% 0/12 • 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)	0.00% 0/37 • 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)
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/14 • 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)	7.1% 1/14 • 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)	0.00% 0/12 • 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)	0.00% 0/37 • 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)
Musculoskeletal and connective tissue disorders Joint instability	0.00% 0/14 • 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)	0.00% 0/14 • 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)	8.3% 1/12 • 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)	0.00% 0/37 • 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)
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/14 • 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)	0.00% 0/14 • 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)	8.3% 1/12 • 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)	0.00% 0/37 • 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)
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/14 • 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)	0.00% 0/14 • 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)	8.3% 1/12 • 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)	0.00% 0/37 • 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)
Blood and lymphatic system disorders Anaemia	0.00% 0/14 • 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)	0.00% 0/14 • 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)	8.3% 1/12 • 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)	0.00% 0/37 • 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)
Ear and labyrinth disorders Vertigo	0.00% 0/14 • 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)	0.00% 0/14 • 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)	8.3% 1/12 • 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)	0.00% 0/37 • 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)