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To determine safety, tolerability and preliminary efficacy of intraglandular injections of MYOBLOC for the treatment of sialorrhea in Parkinsons' Disease patients
This is a multi-center, outpatient, double-blind, placebo-controlled, single treatment, sequential dose escalation study designed to evaluate the safety, tolerability and preliminary efficacy of single doses of MYOBLOC versus placebo for the treatment of sialorrhea in Parkinson's disease patients, lasting approximately 20 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1 | Experimental | 1,500 Units (0.3 mL) MYOBLOC (0.3mL) with 500 Units (0.1 mL) injected into each parotid gland and 250 Units (0.05 mL) inject into each submandibular gland and will be compared to pooled placebo |
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| Treatment 2 | Experimental | 2,500 Units of (0.5mL) MYOBLOC with 1,000 Units (0.2 mL) injected into each parotid gland and 250 Units (0.05mL) inject into each submandibular gland and will be compared to pooled placebo |
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| Treatment 3 | Experimental | 3,500 Units of (0.7mL) MYOBLOC with 1,500 Units (0.3 mL) injected into each parotid gland and 250 Units (0.05mL) inject into each submandibular gland and will be compared to pooled placebo |
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| Treatment 4 | Placebo Comparator | volume-matched placebo injected into each parotid gland and each submandibular gland |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type B (Myobloc) | Biological |
| ||
| Matched placebo to Myobloc |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection | 9 point scale, 0 = no drooling, 9 = severe drooling | baseline versus 4 weeks post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection | 9 point scale (0=no drooling, 9=severe drooling) | baseline vs 12 weeks post injection |
| Change in Unstimulated Salivary Flow Rate at Wk 4 Post-injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Rubin, MD,MBA | Supernus Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Virgilio Evidente | Scottsdale | Arizona | 85259 | United States | ||
| Dr. Ronald Ziman |
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24 centers were initiated to screen and enroll subjects. Enrollment began in July 2007 and completed in March 2008. 54 subjects were enrolled at 17 centers
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| ID | Title | Description |
|---|---|---|
| FG000 | 1500U Myobloc | 1500U Myobloc |
| FG001 | 2500U Myobloc | 2500U Myobloc |
| FG002 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Biological |
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saliva is collected over 5 minutes and weighed to produce a grams/minute "rate"
| baseline vs 4 weeks post-injection |
| Change in Unstimulated Salivary Flow Rate at Wk 12 Post-injection | saliva collected over 5 minutes and weighed to produce a grams/minute "rate" | baseline vs 12 weeks post-injection |
| Northridge |
| California |
| 91325 |
| United States |
| Dr. James Sutton | Oxnard | California | 93030 | United States |
| Dr. Olga Klepitskaya | Denver | Colorado | 80262 | United States |
| Dr. Fernando Pagan | Washington D.C. | District of Columbia | 20007 | United States |
| Dr Hubert Fernandez | Gainesville | Florida | 32610 | United States |
| Dr. Alan Freeman | Atlanta | Georgia | 30329 | United States |
| Dr. Katie Kompoliti | Chicago | Illinois | 60612 | United States |
| Dr. Robert Rodnitzky | Iowa City | Iowa | 52242 | United States |
| Dr. Stephen Reich | Baltimore | Maryland | 21201 | United States |
| Dr. Brad Racette | St Louis | Missouri | 63110 | United States |
| Dr. Eric Molho | Albany | New York | 12205 | United States |
| Dr. Joseph Friedman | Warwick | Rhode Island | 02886 | United States |
| Dr. Vanessa Hinson | Charleston | South Carolina | 29401 | United States |
| Dr. Sam Kabbani | Knoxville | Tennessee | 37923 | United States |
| Dr. Madhavi Thomas | Dallas | Texas | 75231 | United States |
| Dr. Gordon Smith | Salt Lake City | Utah | 84132 | United States |
| Dr. Patrick Hogan | Tacoma | Washington | 98405 | United States |
| 3500U Myobloc |
3500U Myobloc |
| FG003 | Placebo | Placebo |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1500U Myobloc | 1500U Myobloc |
| BG001 | 2500U Myobloc | 2500U Myobloc |
| BG002 | 3500U Myobloc | 3500U Myobloc |
| BG003 | Placebo | Placebo |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection | 9 point scale, 0 = no drooling, 9 = severe drooling | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | points on a scale | baseline versus 4 weeks post-injection |
|
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| Secondary | Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection | 9 point scale (0=no drooling, 9=severe drooling) | Posted | Mean | Standard Deviation | points on a scale | baseline vs 12 weeks post injection |
|
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| Secondary | Change in Unstimulated Salivary Flow Rate at Wk 4 Post-injection | saliva is collected over 5 minutes and weighed to produce a grams/minute "rate" | Posted | Mean | Standard Deviation | grams/minute | baseline vs 4 weeks post-injection |
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| Secondary | Change in Unstimulated Salivary Flow Rate at Wk 12 Post-injection | saliva collected over 5 minutes and weighed to produce a grams/minute "rate" | Posted | Mean | Standard Deviation | grams/minute | baseline vs 12 weeks post-injection |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1500U Myobloc | 1500U Myobloc | 0 | 2 | ||||
| EG001 | 2500U Myobloc | 2500U Myobloc | 1 | 3 | ||||
| EG002 | 3500U Myobloc | 3500U Myobloc | 1 | 2 | ||||
| EG003 | Placebo | Placebo | 3 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
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| Cardiac Failure Congestive | Cardiac disorders | MedDRA | Systematic Assessment |
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| Rectal Hemmorhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Breath Odor | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Saliva Altered | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Tongue Coated | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Trismus | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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Individual investigators may publish results 1 year after the completion of the trial if a multi-center publication has not occurred.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Regulatory Affairs Specialist | Solstice Neurosciences, Inc | regulatoryaffairs@usworldmeds.com |
| ID | Term |
|---|---|
| D012798 | Sialorrhea |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C096323 | rimabotulinumtoxinB |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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