Open-Label and Single-Arm Study of MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adults
Condition: Sialorrhea
MeSH terms: Sialorrhea
Intervention: MYOBLOC
Intervention description: 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
Intervention MeSH terms: rimabotulinumtoxinB; Botulinum Toxins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 187.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Cerebral Palsy; ALS; Stroke; Neuroleptics

Summary:

      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.
    

Eligibility criteria:

        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