NCT00125203

Brief Summary

The purpose of this study is to determine the safety and efficacy of Myobloc in ALS patients who are having excessive drooling. The primary goal of the study is to determine if the patient perceives a benefit from the Myobloc in controlling excessive drooling.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2003

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

March 14, 2012

Status Verified

March 1, 2012

First QC Date

July 27, 2005

Last Update Submit

March 13, 2012

Conditions

Amyotrophic Lateral SclerosisSialorrhea

Keywords

ALSLou Gehrig's DiseaseMotor Neuron DiseaseAmyotrophic Lateral SclerosisSialorrheaHypersalivationExcessive DroolingMyoblocbotulinum toxin type BClostridium botulinum B toxinbotulinum B toxinbotulinum neurotoxin BNeuroBloc

Outcome Measures

Primary Outcomes (1)

  • Global impression of change by subject at eight weeks post injection

Secondary Outcomes (9)

  • Patient's subjective assessment of benefit

  • Change in volume of saliva produced over five minutes (measured with funnel and tube)

  • ALS Functional Rating Scale (ALSFRS)

  • Caregiver's subjective assessment of benefit

  • Change in anticholinergic medication doses and number of times per day suction is used

  • +4 more secondary outcomes

Interventions

Botulinum toxin type B (Myobloc)DRUG
Injection of salivary glandsPROCEDURE

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of probable or definite ALS based on current World Federation of Neurology criteria
  • Between the ages of 21-85, inclusive
  • Sialorrhea refractory to treatment with at least two anticholinergic medications OR has been intolerant of anticholinergic medications due to side effects
  • Capable of giving informed consent
  • Must be able to attend all study visits

You may not qualify if:

  • Patient has any uncontrolled significant medical, psychiatric or neurological disease (other than ALS) over the past 30 days
  • History of ongoing substance abuse
  • History of non-compliance with treatment in other experimental protocols
  • Cannot provide informed consent or comply with evaluation procedures
  • Has received any form of botulinum toxin in the past for any indication
  • Women who are pregnant, lactating, or of child bearing potential not using an adequate form of birth control
  • Currently being treated with coumadin
  • Forced vital capacity (FVC) \<40% of predicted unless the tidal volume is \> 600cc, as patients with significant bulbar weakness may show a falsely low FVC due to bulbar muscle spasticity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Kansas Medical Center/Neurology, 1008 Wescoe

Kansas City, Kansas, 66160-7314, United States

Location

Carolinas MDA Neuromuscular/ALS Center; Carolinas Medical System; 1540 Garden Terrace

Charlotte, North Carolina, 28203, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral SclerosisSialorrheaMotor Neuron Disease

Interventions

rimabotulinumtoxinB

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesSalivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Carlayne E Jackson, MD

    The University of Texas Health Science Center at San Antonio

    PRINCIPAL INVESTIGATOR

  • Charles B Simpson, MD

    The University of Texas Health Science Center at San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 27, 2005

First Posted

July 29, 2005

Study Start

July 1, 2003

Study Completion

August 1, 2007

Last Updated

March 14, 2012

Record last verified: 2012-03

Locations

US(2)