Dysphonia, SpasticPhase 4NCT05110417
Reversal of Botulinum Neurotoxin Injection Related Dysphonia With Pyridostigmine
A Phase 4 study testing Pyridostigmine Bromide 60 Milligrams (mg) in people with Dysphonia, Spastic and Dysphonia, run by Eastern Virginia Medical School at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of pyridostigmine (Mestinon) on patient vocal outcomes after undergoing laryngeal botulinum neurotoxin (BoNT) injections, which is a standard treatment for spasmodic dysphonia. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Dysphonia, Spastic, Dysphonia, Laryngeal Dystonia
- What is being tested?
- Pyridostigmine Bromide 60 Milligrams (mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2021to 1 Jun 2023
- Phase
- Phase 4
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and Females Aged 21-100
- Scheduled for Botulinum Neurotoxin (BoNT) Treatment for Spasmodic Dysphonia (SD)
Who cannot join
- Subjects who are Pregnant or Lactating
- Subjects with Compromised Renal or Cardiac Function
- Subjects with Spasmodic Dysphonia with Superimposed Vocal Tremor
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Eastern Virginia Medical School Ear, Nose, and Throat Surgeons
Norfolk, Virginia, 23507
Addy Tham, MS, 757-388-6264, thama@evms.edu
Laura Stone, RN, 757.388.6238, stonelj@evms.edu
About this study
Official title: Pilot Study of the Efficacy of Pyridostigmine for Reversal of Post Injection Dysphonia Following Botulinum Neurotoxin Laryngeal Chemo-Denervation in Spasmodic Dysphonia
The purpose of this study is to evaluate the effects of pyridostigmine (Mestinon) on patient vocal outcomes after undergoing laryngeal botulinum neurotoxin (BoNT) injections, which is a standard treatment for spasmodic dysphonia. Pyridostigmine (Mestinon) has been used for treatment of BoNT overdose, and it is our hope that it will be beneficial in the management of post BoNT breathy phase.
Read the detailed description
The study will enroll 10 subjects and will involve 1 clinic visit with two sessions over 2 hours.
Participants' voices will then be analyzed via sentence/passage reading, sustained vowel holding, maximum phonation time, as well as subjective ratings of effort. During the second clinic visit, participants will then be administered one 60mg tablet of pyridostigmine (Mestinon) orally, and asked to return to the clinic in 2 hours, when Mestinon has reached peak plasma concentration. Upon returning, participants will repeat the vocal analysis and results will be evaluated for any change in outcome.
Patients who are pregnant, lactating, or have kidney or heart disease should not participate.
- Conditions
- Dysphonia, Spastic, Dysphonia, Laryngeal Dystonia
- Being tested
- Pyridostigmine Bromide 60 Milligrams (mg)
- Keywords
- pyridostigmine, dysphonia, spasmodic dysphonia, Mestinon, botulinum neurotoxin
- Medical subject headings
- Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyridostigmine Bromide 60 Milligrams (mg)Drug
Also called Amneal Pharmaceuticals Pvt. Ltd., Serial Number: 1000462308
One tablet will be provided to patients during the second visit.
| Study group | Role | What they receive |
|---|---|---|
| Pyridostigmine (Mestinon) | Experimental | Pyridostigmine (Mestinon) will be assigned to patients in this arm. Receives: Drug: Pyridostigmine Bromide 60 Milligrams (mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rainbow Passage Reading Pre- and Post-Pyridostigmine (Mestinon)
This pilot study aims to evaluate the efficacy of pyridostigmine (Mestinon) to improve vocal outcomes following laryngeal chemo-denervation with botulinum neurotoxin injection which is a standard of care treatment of adductor spasmodic dysphonia. One of the outcome measures used will be the Rainbow Passage reading. A comparison between pre-pyridostigmine reading and post-pyridostigmine reading will be performed to meet this outcome measure.
Measured: 15 Minutes
CAPE-V Pre- and Post-Pyridostigmine (Mestinon)
This pilot study aims to evaluate the efficacy of pyridostigmine (Mestinon) to improve vocal outcomes following laryngeal chemo-denervation with botulinum neurotoxin injection which is a standard of care treatment of adductor spasmodic dysphonia. Another outcome measurement used will be the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V). A comparison between the pre-pyridostigmine evaluation of the CAPE-V and post-pyridostigmine evaluation of the CAPE-V will be performed to meet this outcome measure.
Measured: 15 Minutes
Glottal Function Index Pre- and Post-Pyridostigmine (Mestinon)
This pilot study aims to evaluate the efficacy of pyridostigmine (Mestinon) to improve vocal outcomes following laryngeal chemo-denervation with botulinum neurotoxin injection which is a standard of care treatment of adductor spasmodic dysphonia. Another primary outcome measure being assessed is the glottal function index (GFI). A comparison between the pre-pyridostigmine GFI and post-pyridostigmine GFI will be performed to meet this outcome measure. Score is ranked from 0 to 5. The lower the GFI score indicates fewer problems/effort.
Measured: 15 Minutes
Adapted Borg Scale Pre- and Post-Pyridostigmine (Mestinon)
This pilot study aims to evaluate the efficacy of pyridostigmine (Mestinon) to improve vocal outcomes following laryngeal chemo-denervation with botulinum neurotoxin injection which is a standard of care treatment of adductor spasmodic dysphonia. Another primary outcome measure being assessed is the adapted Borg scale. A comparison between the pre-pyridostigmine scale rating and the post-pyridostigmine scale rating will be performed to meet this outcome measure. The scale is ranked from 0 to 10. The higher the number indicates more effort in the tasks while a lower number indicates less effort.
Measured: 15 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start20 May 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysphonia, SpasticStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pilot study so all 10 participants will be assigned to the pyridostigmine (Mestinon) treatment arm.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin J Rubinstein, Eastern Virginia Medical School
- Investigators
- Benjamin Rubinstein, MD, Principal investigator, Eastern Virginia Medical School Department of Otolaryngology - Head and Neck Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110417
- Sponsor's protocol ID
- V4.0 28July2021
- Status last verified
- Jul 2022
- First submitted
- 14 Sep 2021
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Efficacy of Pyridostigmine for Reversal of Post Injection Dysphonia Following Botulinum Neurotoxin Laryngeal Chemo-Denervation in Spasmodic Dysphonia
- ClinicalTrials.gov ID
- NCT05110417
- Acronym / sponsor ID
- V4.0 28July2021
- Conditions
- Dysphonia, Spastic, Dysphonia, Laryngeal Dystonia
- Keywords
- pyridostigmine, dysphonia, spasmodic dysphonia, Mestinon, botulinum neurotoxin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 8 Nov 2021 (actual)
- 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 evaluate the effects of pyridostigmine (Mestinon) on patient vocal outcomes after undergoing laryngeal botulinum neurotoxin (BoNT) injections, which is a standard treatment for spasmodic dysphonia. Pyridostigmine (Mestinon) has been used for treatment of BoNT overdose, and it is our hope that it will be beneficial in the management of post BoNT breathy phase.
Detailed description
The study will enroll 10 subjects and will involve 1 clinic visit with two sessions over 2 hours.
Participants' voices will then be analyzed via sentence/passage reading, sustained vowel holding, maximum phonation time, as well as subjective ratings of effort. During the second clinic visit, participants will then be administered one 60mg tablet of pyridostigmine (Mestinon) orally, and asked to return to the clinic in 2 hours, when Mestinon has reached peak plasma concentration. Upon returning, participants will repeat the vocal analysis and results will be evaluated for any change in outcome.
Patients who are pregnant, lactating, or have kidney or heart disease should not participate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pilot study so all 10 participants will be assigned to the pyridostigmine (Mestinon) treatment arm.
| Arm | Type | Receives |
|---|---|---|
| Pyridostigmine (Mestinon) | Experimental | Drug: Pyridostigmine Bromide 60 Milligrams (mg)Pyridostigmine (Mestinon) will be assigned to patients in this arm. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and Females Aged 21-100
- Scheduled for Botulinum Neurotoxin (BoNT) Treatment for Spasmodic Dysphonia (SD)
Key exclusion criteria (3 listed)
- Subjects who are Pregnant or Lactating
- Subjects with Compromised Renal or Cardiac Function
- Subjects with Spasmodic Dysphonia with Superimposed Vocal Tremor
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 |
|---|---|---|
| Pyridostigmine Bromide 60 Milligrams (mg)Also: Amneal Pharmaceuticals Pvt. Ltd., Serial Number: 1000462308One tablet will be provided to patients during the second visit. | Drug | Pyridostigmine (Mestinon) |
Primary outcome
Rainbow Passage Reading Pre- and Post-Pyridostigmine (Mestinon)
Time frame: 15 Minutes
This pilot study aims to evaluate the efficacy of pyridostigmine (Mestinon) to improve vocal outcomes following laryngeal chemo-denervation with botulinum neurotoxin injection which is a standard of care treatment of adductor spasmodic dysphonia. One of the outcome measures used will be the Rainbow Passage reading. A comparison between pre-pyridostigmine reading and post-pyridostigmine reading will be performed to meet this outcome measure.
CAPE-V Pre- and Post-Pyridostigmine (Mestinon)
Time frame: 15 Minutes
This pilot study aims to evaluate the efficacy of pyridostigmine (Mestinon) to improve vocal outcomes following laryngeal chemo-denervation with botulinum neurotoxin injection which is a standard of care treatment of adductor spasmodic dysphonia. Another outcome measurement used will be the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V). A comparison between the pre-pyridostigmine evaluation of the CAPE-V and post-pyridostigmine evaluation of the CAPE-V will be performed to meet this outcome measure.
Glottal Function Index Pre- and Post-Pyridostigmine (Mestinon)
Time frame: 15 Minutes
This pilot study aims to evaluate the efficacy of pyridostigmine (Mestinon) to improve vocal outcomes following laryngeal chemo-denervation with botulinum neurotoxin injection which is a standard of care treatment of adductor spasmodic dysphonia. Another primary outcome measure being assessed is the glottal function index (GFI). A comparison between the pre-pyridostigmine GFI and post-pyridostigmine GFI will be performed to meet this outcome measure. Score is ranked from 0 to 5. The lower the GFI score indicates fewer problems/effort.
Adapted Borg Scale Pre- and Post-Pyridostigmine (Mestinon)
Time frame: 15 Minutes
This pilot study aims to evaluate the efficacy of pyridostigmine (Mestinon) to improve vocal outcomes following laryngeal chemo-denervation with botulinum neurotoxin injection which is a standard of care treatment of adductor spasmodic dysphonia. Another primary outcome measure being assessed is the adapted Borg scale. A comparison between the pre-pyridostigmine scale rating and the post-pyridostigmine scale rating will be performed to meet this outcome measure. The scale is ranked from 0 to 10. The higher the number indicates more effort in the tasks while a lower number indicates less effort.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
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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.
Benjamin Rubinstein, MD principal investigator
Eastern Virginia Medical School Department of Otolaryngology - Head and Neck Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pyridostigmine Bromide 60 Milligrams (mg) in people with Dysphonia, Spastic and Dysphonia, run by Eastern Virginia Medical School at 1 site 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Addy Tham, MS (757.388.6264, thama@evms.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rainbow Passage Reading Pre- and Post-Pyridostigmine (Mestinon) (time frame: 15 Minutes). The study lists 4 primary outcomes in all. 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 27 Jul 2022.