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Multicenter, open-label, outpatient study of the safety and effectiveness of repeated doses of MYOBLOC over a 1-year duration in adult subjects with troublesome sialorrhea.
Multicenter, open-label, outpatient study of the safety and effectiveness of repeated doses of MYOBLOC over a 1-year duration in adult subjects with troublesome sialorrhea. The primary goal is to determine the long-term safety and tolerability of MYOBLOC (administered intraglandularly as single total dose of 3,500 Units) treatments every 13 weeks over a maximum possible duration of 1 year in adult subjects with troublesome sialorrhea. The secondary goal is to assess the magnitude of therapeutic response of MYOBLOC (administered intraglandularly as a single total dose of 3,500 Units) using effectiveness assessments performed at intervals after treatments every 13 weeks over a maximum possible duration of 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MYOBLOC Injection | Experimental | After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections over the course of 1 year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MYOBLOC | Drug | After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments via injections into the submandibular and parotid glands. Subjects will undergo safety and effectiveness assessments at Weeks 4, 8, 13, 17, 26, 30, 39, 43, and 52, and telephone follow up will occur at Weeks 21, 34, and 47 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence, Seriousness, Severity, and Causality Assessment of Treatment Emergent Adverse Events (TEAE) | TEAEs Related to Study Medication include TEAEs classified as Possibly, Probably and Definitely Related. Treatment Session (TS) | Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1 |
| Occurrence of Adverse Events of Special Interest (AESI) | Treatment Session (TS) AESI includes: Aspiration, Aspirational pneumonia, Choking and Dysphagia. | Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1 |
| Columbia Suicide Rating Scale (C-SSRS): Suicidal Ideation, Behavior Scores and Intensity Scores | Participants Analyzed does not match the Participant Flow because one participant discontinued prior to the first post-injection visit. Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 |
| Occurrence of Dental Adverse Events | Treatment Session (TS) | Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Unstimulated Salivary Flow Rate (USFR): Treatment Sessions 1-4 | For Treatment Sessions 2-4, the change from baseline is calculated using the Week 13 value from the previous Treatment Session as the new baseline. Week 8 was only assessed in Treatment Session 1. Treatment Session (TS) Participants Analyzed does not match the Participant Flow because patient data was not always captured for each endpoint at every visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Rubin, PhD | Supernus Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85013 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40498248 | Derived | Pahwa R, Molho E, Lew M, Dashtipour K, Gil RA, Revilla FJ, Clinch T, Qin P, Isaacson SH; OPen Label Trial of Intraglandular MYobloc injections for Sialorrhea Treatment (OPTIMYST) study group. Long-Term Safety and Efficacy of Repeated Cycles of RimabotulinumtoxinB in the Treatment of Chronic Sialorrhea: Results of the OPTIMYST Trial. Neurol Ther. 2025 Aug;14(4):1553-1567. doi: 10.1007/s40120-025-00777-z. Epub 2025 Jun 11. |
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All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).
Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.
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| ID | Title | Description |
|---|---|---|
| FG000 | MYOBLOC: 3500U | After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| MYOBLOC: Treatment Session 1 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 23, 2015 | Sep 6, 2019 |
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|
|
| Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 |
| Change From Baseline in Clinical Global Impression of Severity (CGI-S) | CGI-S will be used to record the severity of illness (sialorrhea) on a 7-point scale ranging from a score of 1, "normal" to a score of 7, "among the most extremely ill patients". Treatment Session (TS) Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit. | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 |
| Clinical Global Impression of Change (CGI-C) | CGI-C will be used to record change or improvement of illness (sialorrhea) on a 7-point scale ranging from a score of 1, "very much improved" to a score of 7, "very much worse". Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit. Treatment Session (TS) | TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 |
| Change From Baseline in Drooling Frequency and Severity Scale Performed by Trained Assessor (DFSS-I) | The DFSS will be used to assess the frequency and severity of drooling on a 5-point scale ranging from a score of 1, dry never drools to a score of 5, profuse clothing hands tray objects become wet. Drooling frequency will be assessed on a 4-point scale ranging from a score of 1, never drools to a score of 4, constantly drools. Treatment Session (TS) Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit. The severity score and frequency score are summed together to create the DFSS total score (range 2-9). A decrease from baseline indicates improvement. | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 |
| Change From Baseline in Drooling Frequency and Severity Scale Performed by Subject (DFSS-S) | The DFSS will be used to assess the frequency and severity of drooling on a 5-point scale ranging from a score of 1, dry never drools to a score of 5, profuse clothing hands tray objects become wet. Drooling frequency will be assessed on a 4-point scale ranging from a score of 1, never drools to a score of 4, constantly drools. Treatment Session (TS) Participants Analyzed does not match the Participant Flow because patient data was not always captured for each endpoint at every visit. The severity score and frequency score are summed together to create the DFSS total score (range 2 -9). A decrease from baseline indicates improvement. | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 |
| Change From Baseline in Patient Global Impression of Severity (PGI-S) | The PGI-S scale will be used by the subject to rate the severity of his/her illness (sialorrhea) on an 7-point scale ranging from a score of 1, "normal" to a score of 7, "among the most extremely ill". Treatment Session (TS) Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit. | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 |
| Patient Global Impression of Change (PGI-C) | The PGI-C scale will be used by the subject to rate the change in symptoms of his/her illness (sialorrhea) on an 7-point scale ranging from a score of 1, "very much improved" to a score of 7, "very much worse". Treatment Session (TS) Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit. | TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 |
| Change From Baseline in Drooling Impact Score (DIS) | The DIS is a 10-item questionnaire with each item rated by the subject to evaluate the impact of sialorrhea on daily activities (e.g., speech, social activities). Treatment Session (TS) Participants Analyzed does not match the Participant Flow because patient data was not always captured for each endpoint at every visit. Subject is requested to compare their current status to their last study visit using a 4-point scale ranging from a score of 1, not at all to a score of 4, very much. The DIS total score ranges from 10 to 40. A negative change from baseline indicates a positive clinical outcome. | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Scottsdale | Arizona | 85259 | United States |
| Loma Linda | California | 92354 | United States |
| Los Angeles | California | 90033 | United States |
| Aurora | Colorado | 80045 | United States |
| Atlantis | Florida | 33462 | United States |
| Boca Raton | Florida | 33486 | United States |
| Orlando | Florida | 32806 | United States |
| Port Charlotte | Florida | 33980 | United States |
| Atlanta | Georgia | 30329 | United States |
| Kansas City | Kansas | 66160 | United States |
| Overland Park | Kansas | 66211 | United States |
| Elkridge | Maryland | 21075 | United States |
| Farmington Hills | Michigan | 48334 | United States |
| St Louis | Missouri | 63110 | United States |
| Las Vegas | Nevada | 89145 | United States |
| Edison | New Jersey | 08818 | United States |
| Centerville | Ohio | 45459 | United States |
| Tulsa | Oklahoma | 74136 | United States |
| Greenville | South Carolina | 29615 | United States |
| Cordova | Tennessee | 38018 | United States |
| San Antonio | Texas | 78229 | United States |
| Kirkland | Washington | 98034 | United States |
| Spokane | Washington | 99202 | United States |
| Tacoma | Washington | 98409 | United States |
| Grodno | 230017 | Belarus |
| Dnipropetrovsk | 49027 | Ukraine |
| Ivano-Frankivsk | 76008 | Ukraine |
| Kharkiv | 61068 | Ukraine |
| Lviv | 79010 | Ukraine |
| Odesa | 65025 | Ukraine |
| Rivne | 33010 | Ukraine |
| Uzhhorod | 88018 | Ukraine |
| Zaporizhzhya | 69600 | Ukraine |
| COMPLETED |
|
| NOT COMPLETED |
|
| MYOBLOC: Treatment Session 2 |
|
| MYOBLOC: Treatment Session 3 |
|
| MYOBLOC: Treatment Session 4 |
|
Eligible subjects included male or females aged 18 to 85 years who are seeking treatment for troublesome sialorrhea for at least 3 months before screening.
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| ID | Title | Description |
|---|---|---|
| BG000 | MYOBLOC | MYOBLOC: After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments via injections into the submandibular and parotid glands. Subjects will undergo safety and effectiveness assessments at Weeks 4, 8, 13 for Treatment Session 1; Weeks 4, 13 for Treatment Sessions 2-4. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Unstimulated Salivary Flow Rate (USFR) | Mean | Standard Deviation | g/minute |
| ||||||||||||||||||||||
| Clinical Global Impression of Severity (CGI-S) | Mean | Standard Deviation | units on a scale (1-7) |
| ||||||||||||||||||||||
| Patient Global Impression of Severity (PGI-S) | Mean | Standard Deviation | units on a scale (1-7) |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Occurrence, Seriousness, Severity, and Causality Assessment of Treatment Emergent Adverse Events (TEAE) | TEAEs Related to Study Medication include TEAEs classified as Possibly, Probably and Definitely Related. Treatment Session (TS) | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U or 3000 U). | Posted | Number | participants | Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1 |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Occurrence of Adverse Events of Special Interest (AESI) | Treatment Session (TS) AESI includes: Aspiration, Aspirational pneumonia, Choking and Dysphagia. | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | Posted | Number | participants | Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Columbia Suicide Rating Scale (C-SSRS): Suicidal Ideation, Behavior Scores and Intensity Scores | Participants Analyzed does not match the Participant Flow because one participant discontinued prior to the first post-injection visit. Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | Posted | Number | participants | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Occurrence of Dental Adverse Events | Treatment Session (TS) | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | Posted | Number | participants | Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Unstimulated Salivary Flow Rate (USFR): Treatment Sessions 1-4 | For Treatment Sessions 2-4, the change from baseline is calculated using the Week 13 value from the previous Treatment Session as the new baseline. Week 8 was only assessed in Treatment Session 1. Treatment Session (TS) Participants Analyzed does not match the Participant Flow because patient data was not always captured for each endpoint at every visit. | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | Posted | Mean | Standard Deviation | g/minute | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Clinical Global Impression of Severity (CGI-S) | CGI-S will be used to record the severity of illness (sialorrhea) on a 7-point scale ranging from a score of 1, "normal" to a score of 7, "among the most extremely ill patients". Treatment Session (TS) Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit. | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Global Impression of Change (CGI-C) | CGI-C will be used to record change or improvement of illness (sialorrhea) on a 7-point scale ranging from a score of 1, "very much improved" to a score of 7, "very much worse". Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit. Treatment Session (TS) | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | Posted | Mean | Standard Deviation | units on a scale | TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Drooling Frequency and Severity Scale Performed by Trained Assessor (DFSS-I) | The DFSS will be used to assess the frequency and severity of drooling on a 5-point scale ranging from a score of 1, dry never drools to a score of 5, profuse clothing hands tray objects become wet. Drooling frequency will be assessed on a 4-point scale ranging from a score of 1, never drools to a score of 4, constantly drools. Treatment Session (TS) Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit. The severity score and frequency score are summed together to create the DFSS total score (range 2-9). A decrease from baseline indicates improvement. | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Drooling Frequency and Severity Scale Performed by Subject (DFSS-S) | The DFSS will be used to assess the frequency and severity of drooling on a 5-point scale ranging from a score of 1, dry never drools to a score of 5, profuse clothing hands tray objects become wet. Drooling frequency will be assessed on a 4-point scale ranging from a score of 1, never drools to a score of 4, constantly drools. Treatment Session (TS) Participants Analyzed does not match the Participant Flow because patient data was not always captured for each endpoint at every visit. The severity score and frequency score are summed together to create the DFSS total score (range 2 -9). A decrease from baseline indicates improvement. | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Patient Global Impression of Severity (PGI-S) | The PGI-S scale will be used by the subject to rate the severity of his/her illness (sialorrhea) on an 7-point scale ranging from a score of 1, "normal" to a score of 7, "among the most extremely ill". Treatment Session (TS) Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit. | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Patient Global Impression of Change (PGI-C) | The PGI-C scale will be used by the subject to rate the change in symptoms of his/her illness (sialorrhea) on an 7-point scale ranging from a score of 1, "very much improved" to a score of 7, "very much worse". Treatment Session (TS) Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit. | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | Posted | Mean | Standard Deviation | units on a scale | TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Drooling Impact Score (DIS) | The DIS is a 10-item questionnaire with each item rated by the subject to evaluate the impact of sialorrhea on daily activities (e.g., speech, social activities). Treatment Session (TS) Participants Analyzed does not match the Participant Flow because patient data was not always captured for each endpoint at every visit. Subject is requested to compare their current status to their last study visit using a 4-point scale ranging from a score of 1, not at all to a score of 4, very much. The DIS total score ranges from 10 to 40. A negative change from baseline indicates a positive clinical outcome. | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 |
|
through study completion, up to 1 year
Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MYOBLOC: Treatment Session 1 | After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | 1 | 187 | 9 | 187 | 44 | 187 |
| EG001 | MYOBLOC: Treatment Session 2 | After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | 4 | 177 | 18 | 177 | 34 | 177 |
| EG002 | MYOBLOC: Treatment Session 3 | After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | 2 | 50 | 4 | 50 | 7 | 50 |
| EG003 | MYOBLOC: Treatment Session 4 | After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | 1 | 24 | 2 | 24 | 4 | 24 |
| EG004 | ALL MYOBLOC: Treatment Sessions 1-4 | After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments at Weeks 4, 8, 13 for Treatment Session 1, Weeks 4 and 13 for Treatment Sessions 2-4. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | 8 | 187 | 33 | 187 | 73 | 187 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Coronary artery disease | Cardiac disorders | Systematic Assessment |
| ||
| Large intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Post procedural compication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Hip fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Multiple system atrophy | Nervous system disorders | Systematic Assessment |
| ||
| Amyotrophic lateral sclerosis | Nervous system disorders | Systematic Assessment | Captured ALS subjects progression of disease. |
| |
| Freezing phenomenon | Nervous system disorders | Systematic Assessment |
| ||
| Delirium | Psychiatric disorders | Systematic Assessment |
| ||
| Mental status changes | Psychiatric disorders | Systematic Assessment |
| ||
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | Systematic Assessment |
| ||
| Subarachnoid haemorrhage | Nervous system disorders | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Urosepsis | Infections and infestations | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Malnutrition | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dental caries | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Amyotrophic lateral sclerosis | Nervous system disorders | Systematic Assessment | Captured ALS subjects progression of disease. |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Najeebah Abdul-Musawir, MD, Director of Clinical Research | Supernus Pharmaceuticals, Inc. | 2404035571 | nabdulmusawir@supernus.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 22, 2018 | Sep 6, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012798 | Sialorrhea |
| D002547 | Cerebral Palsy |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C096323 | rimabotulinumtoxinB |
Not provided
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Belarus |
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| Severe TEAEs |
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| TEAEs Related to Study Medication |
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| OG003 | Treatment Session 4 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments. |
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| OG003 | Treatment Session 2: Week 4 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13. |
| OG004 | Treatment Session 2: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13. |
| OG005 | Treatment Session 3: Week 4 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13. |
| OG006 | Treatment Session 3: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13. |
| OG007 | Treatment Session 4: Week 4 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13. |
| OG008 | Treatment Session 4: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13. |
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| Treatment Session 4 |
Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments. |
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| OG002 | Treatment Session 1: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13. |
| OG003 | Treatment Session 2: Week 4 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13. |
| OG004 | Treatment Session 2: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13. |
| OG005 | Treatment Session 3: Week 4 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13. |
| OG006 | Treatment Session 3: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13. |
| OG007 | Treatment Session 4: Week 4 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13. |
| OG008 | Treatment Session 4: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13. |
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| OG002 |
| Treatment Session 1: Week 13 |
Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13. |
| OG003 | Treatment Session 2: Week 4 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13. |
| OG004 | Treatment Session 2: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13. |
| OG005 | Treatment Session 3: Week 4 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13. |
| OG006 | Treatment Session 3: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13. |
| OG007 | Treatment Session 4: Week 4 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13. |
| OG008 | Treatment Session 4: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13. |
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Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13. |
| OG003 | Treatment Session 2: Week 4 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13. |
| OG004 | Treatment Session 2: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13. |
| OG005 | Treatment Session 3: Week 4 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13. |
| OG006 | Treatment Session 3: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13. |
| OG007 | Treatment Session 4: Week 4 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13. |
| OG008 | Treatment Session 4: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13. |
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Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.
| OG002 | Treatment Session 1: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13. |
| OG003 | Treatment Session 2: Week 4 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13. |
| OG004 | Treatment Session 2: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13. |
| OG005 | Treatment Session 3: Week 4 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13. |
| OG006 | Treatment Session 3: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13. |
| OG007 | Treatment Session 4: Week 4 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13. |
| OG008 | Treatment Session 4: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13. |
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Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.
| OG002 | Treatment Session 1: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13. |
| OG003 | Treatment Session 2: Week 4 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13. |
| OG004 | Treatment Session 2: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13. |
| OG005 | Treatment Session 3: Week 4 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13. |
| OG006 | Treatment Session 3: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13. |
| OG007 | Treatment Session 4: Week 4 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13. |
| OG008 | Treatment Session 4: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13. |
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| OG002 |
| Treatment Session 1: Week 13 |
Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13. |
| OG003 | Treatment Session 2: Week 4 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13. |
| OG004 | Treatment Session 2: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13. |
| OG005 | Treatment Session 3: Week 4 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13. |
| OG006 | Treatment Session 3: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13. |
| OG007 | Treatment Session 4: Week 4 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13. |
| OG008 | Treatment Session 4: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13. |
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| Treatment Session 1: Week 13 |
Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13. |
| OG003 | Treatment Session 2: Week 4 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13. |
| OG004 | Treatment Session 2: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13. |
| OG005 | Treatment Session 3: Week 4 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13. |
| OG006 | Treatment Session 3: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13. |
| OG007 | Treatment Session 4: Week 4 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13. |
| OG008 | Treatment Session 4: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13. |
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| OG002 | Treatment Session 1: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13. |
| OG003 | Treatment Session 2: Week 4 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13. |
| OG004 | Treatment Session 2: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13. |
| OG005 | Treatment Session 3: Week 4 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13. |
| OG006 | Treatment Session 3: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13. |
| OG007 | Treatment Session 4: Week 4 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13. |
| OG008 | Treatment Session 4: Week 13 | Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13. |
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