Open-Label and Single-Arm Study of MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adults "OPTIMYST"

Completed

Phase 3 Results N/A

Update History

30 Aug '17
The eligibility criteria were updated.
New
Inclusion Criteria: - Seeking treatment for troublesome sialorrhea for at least 3 months that is occurring secondary to any disorder or related to any cause, including, but not limited to, Parkinson's Disease (PD), adult cerebral palsy, amyotrophic lateral sclerosis (ALS), stroke, traumatic brain injury, oral cancer, and side effects of other medications. - Able to read and provide written informed consent before enrollment into the study, or the subject's caregiver (Legally Authorized Representative) can provide written informed consent. - Male or female, 18 to 85 years of age (inclusive). - Minimum unstimulated salivary flow rate of 0.2 g/min at screening - Minimum Investigator's Drooling Frequency and Severity Scale (DFSS) score of 4 at screening. - Ability and availability to participate in the study for up to 1 year (ALS subjects: ability and availability to participate in the study for at least 6 months), based on overall health of the subject and disease prognosis Exclusion Criteria: - A moderate to high risk of aspiration will exclude participation in this study. Subjects whose risk of aspiration are judged by the Investigator to be satisfactorily controlled by placement of PEG tube or G-tube for nutritional support are eligible to participate. - Respiratory forced vital capacity (FVC) of <20% of predicted - Prior botulinum toxin type A or B treatment in the salivary gland(s) identified for treatment in this study within 24 weeks before screening. Prior botulinum toxin type A or B treatment into other anatomical regions not selected for treatment in this study is not exclusionary, but must have occurred at least 12 weeks before screening - Subjects should be excluded if, in the Investigator's opinion, the subject failed to respond to previous treatment with botulinum toxin. Subjects should not receive nor have any plans for receiving any botulinum toxin treatment, other than the study drug (MYOBLOC), during the entire course of the study (from the point the informed consent is signed until subject's participation is complete). - Concomitant use, or exposure within 5 half-lives of screening, of aminoglycoside antibiotics, curare-like agents, or other agents that interfere with neuromuscular function - Prior salivary gland surgery - Current treatment or treatment at any time during the study with Coumadin® (warfarin) or similar anti-coagulant medications. Anti-platelet medications are not specifically exclusionary - Evidence of any clinically significant neurologic disease - Pregnancy or lactation - Anticipated or scheduled surgery during the study period. A PEG tube/G tube may be placed for nutritional support at any time during the study and will not exclude the subject from continued study participation. - Major surgery (requiring general anesthesia, except PEG tube/G tube placement ) within the previous 6 months before screening. - Current infection at the sialorrhea treatment injection site(s) - History of drug or alcohol abuse currently or within the previous 6 months - Participation in another clinical drug, device, or biological agent study within 30 days of screening or while participating in this study
Old
Inclusion Criteria: - Seeking treatment for troublesome sialorrhea for at least 3 months that is occurring secondary to any disorder or related to any cause, including, but not limited to, Parkinson's Disease (PD), adult cerebral palsy, amyotrophic lateral sclerosis (ALS), stroke, traumatic brain injury, oral cancer, and side effects of other medications. - Able to read and provide written informed consent before enrollment into the study, or the subject's caregiver (Legally Authorized Representative) can provide written informed consent. - Male or female, 18 to 85 years of age (inclusive). - Minimum unstimulated salivary flow rate of 0.2 g/min at screening - Minimum Investigator's Drooling Frequency and Severity Scale (DFSS) score of 4 at screening. - Ability and availability to participate in the study for up to 1 year (ALS subjects: ability and availability to participate in the study for at least 6 months), based on overall health of the subject and disease prognosis Exclusion Criteria: - A moderate to high risk of aspiration will exclude participation in this study. Subjects whose risk of aspiration are judged by the Investigator to be satisfactorily controlled by placement of PEG tube or G-tube for nutritional support are eligible to participate. - Respiratory forced vital capacity (FVC) of <20% of predicted - Prior botulinum toxin type A or B treatment in the salivary gland(s) identified for treatment in this study within 24 weeks before screening. Prior botulinum toxin type A or B treatment into other anatomical regions not selected for treatment in this study is not exclusionary, but must have occurred at least 12 weeks before screening - Subjects should be excluded if, in the Investigator's opinion, the subject failed to respond to previous treatment with botulinum toxin. Subjects should not receive nor have any plans for receiving any botulinum toxin treatment, other than the study drug (MYOBLOC), during the entire course of the study (from the point the informed consent is signed until subject's participation is complete). - Concomitant use, or exposure within 5 half-lives of screening, of aminoglycoside antibiotics, curare-like agents, or other agents that interfere with neuromuscular function - Prior salivary gland surgery - Current treatment or treatment at any time during the study with Coumadin® (warfarin) or similar anti-coagulant medications. Anti-platelet medications are not specifically exclusionary - Evidence of any clinically significant neurologic disease - Pregnancy or lactation - Anticipated or scheduled surgery during the study period. A PEG tube/G tube may be placed for nutritional support at any time during the study and will not exclude the subject from continued study participation. - Major surgery (requiring general anesthesia, except PEG tube/G tube placement ) within the previous 6 months before screening. - Current infection at the sialorrhea treatment injection site(s) - History of drug or alcohol abuse currently or within the previous 6 months - Participation in another clinical drug, device, or biological agent study within 30 days of screening or while participating in this study
5 May '17
The gender criteria for eligibility was updated to "All."
A location was updated in Phoenix.
New
The overall status was removed for Name Unavailable.
A location was updated in Scottsdale.
New
The overall status was removed for Name Unavailable.
A location was updated in Scottsdale.
New
The overall status was removed for Name Unavailable.
A location was updated in Loma Linda.
New
The overall status was removed for Name Unavailable.
A location was updated in Aurora.
New
The overall status was removed for Name Unavailable.
A location was updated in Atlantis.
New
The overall status was removed for Name Unavailable.
A location was updated in Boca Raton.
New
The overall status was removed for Name Unavailable.
A location was updated in Orlando.
New
The overall status was removed for Name Unavailable.
A location was updated in Port Charlotte.
New
The overall status was removed for Name Unavailable.
A location was updated in Atlanta.
New
The overall status was removed for Name Unavailable.
A location was updated in Kansas City.
New
The overall status was removed for Name Unavailable.
A location was updated in Overland Park.
New
The overall status was removed for Name Unavailable.
A location was updated in Elkridge.
New
The overall status was removed for Name Unavailable.
A location was updated in Farmington Hills.
New
The overall status was removed for Name Unavailable.
A location was updated in Las Vegas.
New
The overall status was removed for Name Unavailable.
A location was updated in Edison.
New
The overall status was removed for Name Unavailable.
A location was updated in Centerville.
New
The overall status was removed for Name Unavailable.
A location was updated in Tulsa.
New
The overall status was removed for Name Unavailable.
A location was updated in Cordova.
New
The overall status was removed for Name Unavailable.
A location was updated in San Antonio.
New
The overall status was removed for Name Unavailable.
A location was updated in Kirkland.
New
The overall status was removed for Name Unavailable.
A location was updated in Spokane.
New
The overall status was removed for Name Unavailable.
A location was updated in Tacoma.
New
The overall status was removed for Name Unavailable.
A location was updated in Grodno.
New
The overall status was removed for Name Unavailable.
A location was updated in Dnipropetrovsk.
New
The overall status was removed for Name Unavailable.
A location was updated in Ivano-Frankivsk.
New
The overall status was removed for Name Unavailable.
A location was updated in Kharkiv.
New
The overall status was removed for Name Unavailable.
A location was updated in Lviv.
New
The overall status was removed for Name Unavailable.
A location was updated in Odesa.
New
The overall status was removed for Name Unavailable.
A location was updated in Rivne.
New
The overall status was removed for Name Unavailable.
A location was updated in Uzhgorod.
New
The overall status was removed for Name Unavailable.
6 Oct '16
A location was updated in Elkridge.
New
The overall status was removed for Name Unavailable.
28 Nov '15
A location was updated in Centerville.
New
The overall status was removed for Name Unavailable.