A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients

Solstice Neurosciences

Status and phase: Completed; Phase 2

Conditions: Drooling

Treatments: Biological: Botulinum Toxin Type B (Myobloc); Biological: Matched placebo to Myobloc

Study type: Interventional

Funder types: Industry

Identifiers

NCT00515437

SN-SIAL-201

Details and patient eligibility

About

To determine safety, tolerability and preliminary efficacy of intraglandular injections of MYOBLOC for the treatment of sialorrhea in Parkinsons' Disease patients

Full description

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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Parkinsons' Disease patients with Sialorrhea for at least 3 months

Exclusion criteria

• Patients with non-idiopathic PD parkinsonism
• Patients previously exposed to botulinum toxins
• Patients with a history of aspiration pneumonia, moderate/severe choking and/or moderate/severe dysphagia
• Patients with prior salivary gland surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

1500U Myobloc

Treatment:

Biological: Botulinum Toxin Type B (Myobloc)

2

Experimental group

Description:

2500U Myobloc

Treatment:

Biological: Botulinum Toxin Type B (Myobloc)

3

Experimental group

Description:

3500U Myobloc

Treatment:

Biological: Botulinum Toxin Type B (Myobloc)

4

Placebo Comparator group

Description:

pooled placebo

Treatment:

Biological: Matched placebo to Myobloc