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Completed

NCT Number: NCT00515437

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

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

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Key information

Conditions

Drooling Mouth Diseases Salivary Gland Diseases Sialorrhea Stomatognathic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dr Virgilio Evidente, Scottsdale, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin Type B (Myobloc)

Biological

Matched placebo to Myobloc

Biological

Primary outcomes

  1. Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection

    Time frame: baseline versus 4 weeks post-injection

    9 point scale, 0 = no drooling, 9 = severe drooling

Secondary outcomes

  1. Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection

    Time frame: baseline vs 12 weeks post injection

    9 point scale (0=no drooling, 9=severe drooling)

  2. Change in Unstimulated Salivary Flow Rate at Wk 4 Post-injection

    Time frame: baseline vs 4 weeks post-injection

    saliva is collected over 5 minutes and weighed to produce a grams/minute "rate"

  3. Change in Unstimulated Salivary Flow Rate at Wk 12 Post-injection

    Time frame: baseline vs 12 weeks post-injection

    saliva collected over 5 minutes and weighed to produce a grams/minute "rate"

Sponsors and collaborators

Lead sponsor

Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC

Industry

Registry information

Official study title

A Multi-Center, Randomized, Double-blind, Placebo-Controlled,Sequential Dose Escalation, Safety, Tolerability, and Preliminary Efficacy Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 13, 2007
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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