Amyotrophic Lateral SclerosisPhase 2/3NCT00125203
Study of Myobloc in the Treatment of Sialorrhea (Drooling) in Patients With Amyotrophic Lateral Sclerosis (ALS)
A Phase 2/3 study testing Botulinum toxin type B (Myobloc) and Injection of salivary glands in people with Amyotrophic Lateral Sclerosis and Sialorrhea, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Sialorrhea
- What is being tested?
- Botulinum toxin type B (Myobloc) and Injection of salivary glands
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2003to Aug 2007
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Carolinas MDA Neuromuscular/ALS Center; Carolinas Medical System; 1540 Garden Terrace
Charlotte, North Carolina, 28203
University of Kansas Medical Center/Neurology, 1008 Wescoe
Kansas City, Kansas, 66160-7314
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Safety and Efficacy of Botulinum Toxin Type B (Myobloc) in Sialorrhea in Amyotrophic Lateral Sclerosis
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.
Read the detailed description
The secondary goals of this study are to:
- determine the safety of bilateral injections of Myobloc into the parotid and submandibular glands as an effort to control sialorrhea;
- determine by objective measures if the Myobloc injection decreases the saliva produced;
- determine caregiver perceived benefit from Myobloc injection.
- Conditions
- Amyotrophic Lateral Sclerosis, Sialorrhea
- Being tested
- Botulinum toxin type B (Myobloc), Injection of salivary glands
- Keywords
- ALS, Lou Gehrig's Disease, Motor Neuron Disease, Amyotrophic Lateral Sclerosis, Sialorrhea, Hypersalivation, Excessive Drooling, Myobloc, botulinum toxin type B, Clostridium botulinum B toxin, botulinum B toxin, botulinum neurotoxin B, NeuroBloc
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Sialorrhea, Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type B (Myobloc)Drug
Injection of salivary glandsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
SEQOL-DW
Duration of benefit
Assessment of treatment assignment (final visit only)
Global assessment of change by investigator
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2005 (estimated)
- Study startJul 2003
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- ALS Association, University of Kansas, Carolinas MDA Neuromuscular/ALS Center-Carolinas Medical System
- Investigators
- Carlayne E Jackson, MD, Principal investigator, The University of Texas Health Science Center at San AntonioCharles B Simpson, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125203
- Sponsor's protocol ID
- BB-IND 11090
- Status last verified
- Mar 2012
- First submitted
- 27 Jul 2005
- Last updated
- 14 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of Safety and Efficacy of Botulinum Toxin Type B (Myobloc) in Sialorrhea in Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT00125203
- Acronym / sponsor ID
- BB-IND 11090
- Conditions
- Amyotrophic Lateral Sclerosis, Sialorrhea
- Keywords
- ALS, Lou Gehrig's Disease, Motor Neuron Disease, Amyotrophic Lateral Sclerosis, Sialorrhea, Hypersalivation, Excessive Drooling, Myobloc
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- ALS Association, University of Kansas, Carolinas MDA Neuromuscular/ALS Center-Carolinas Medical System
- Study start
- Jul 2003
- Study completion
- Aug 2007 (actual)
- First posted
- 29 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The secondary goals of this study are to:
- determine the safety of bilateral injections of Myobloc into the parotid and submandibular glands as an effort to control sialorrhea;
- determine by objective measures if the Myobloc injection decreases the saliva produced;
- determine caregiver perceived benefit from Myobloc injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type B (Myobloc) | Drug | – |
| Injection of salivary glands | Procedure or surgery | – |
Primary outcome
Global impression of change by subject at eight weeks post injection
9 secondary outcomes
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
SEQOL-DW
Duration of benefit
Assessment of treatment assignment (final visit only)
Global assessment of change by investigator
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlayne E Jackson, MD principal investigator
The University of Texas Health Science Center at San Antonio
Charles B Simpson, MD principal investigator
The University of Texas Health Science Center at San Antonio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Botulinum toxin type B (Myobloc) and Injection of salivary glands in people with Amyotrophic Lateral Sclerosis and Sialorrhea, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global impression of change by subject at eight weeks post injection. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2012.