NCT04648891 is a Phase 2, PHASE3 clinical trial of Lidocaine in Spasmodic Dysphonia, sponsored by Mayo Clinic.

Who is sponsoring NCT04648891?

NCT04648891 is sponsored by Mayo Clinic.

What drugs are being tested in NCT04648891?

Interventions in NCT04648891: Lidocaine, Vibrating wand.

What condition does NCT04648891 study?

NCT04648891 studies Spasmodic Dysphonia.

Is NCT04648891 still recruiting?

NCT04648891 is currently completed. Last updated 23 May 2024.

Are results published for NCT04648891?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-05-23 · How we verify

NCT04648891

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Spasmodic Dysphonia Pain

Completed Phase 2, PHASE3 Results posted Last updated 23 May 2024

What this trial tests

Phase 2, PHASE3 trial testing Lidocaine in Spasmodic Dysphonia in 32 participants. Completed in 1 July 2023.

Timeline

1 August 2021

Primary endpoint
1 July 2023

1 July 2023

Quick facts

Lead sponsor	Mayo Clinic
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	1 August 2021
Primary completion	1 July 2023
Estimated completion	1 July 2023
Sites	1 location across United States

Drugs / interventions tested

Lidocaine — full drug profile →
Vibrating wand

Conditions studied

Spasmodic Dysphonia — all drugs for Spasmodic Dysphonia →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Spasmodic Dysphonia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pain Experienced Primary · 6 months

Measured on a Visual Analogue Scale where 0 = no pain and 10 = worst pain

Control

Group	Value	95% CI
Laryngeal Injection of Botox Via a Transcricothyroid Approach	2	1 – 3

Lidocaine

Group	Value	95% CI
Laryngeal Injection of Botox Via a Transcricothyroid Approach	2	1 – 3.5

Vibrating Wand

Group	Value	95% CI
Laryngeal Injection of Botox Via a Transcricothyroid Approach	2	1 – 3

Subject Preference Secondary · 6 months

Subjects were asked which technique (Control, Lidocaine or Vibrating wand) they preferred the most

Control

Group	Value	95% CI
Laryngeal Injection of Botox Via a Transcricothyroid Approach	6

Lidocaine

Group	Value	95% CI
Laryngeal Injection of Botox Via a Transcricothyroid Approach	12

Vibrating Wand

Group	Value	95% CI
Laryngeal Injection of Botox Via a Transcricothyroid Approach	14

Sponsor's own description

This study aims to identify adjuvant methods to improve patient comfort during in-office laryngology procedures.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Lidocaine

Trials testing the same drug.

NCT07488832 — Intravenous Lidocaine Infusion in Lumbar Fusion Surgery · NA · recruiting
NCT07445191 — Efficacy of Triamcinolone-Lidocaine Mix in Trigger Points Injection of Masseter Muscle: Double-blinded, Randomized Contr · Phase 2, PHASE3 · not yet recruiting
NCT07422558 — Intravenous Nalbuphine Versus Lidocaine for Prevention of Propofol Injection Pain · NA · not yet recruiting
NCT06923787 — Effect of Perioperative Intravenous Infusion of Lidocaine on the Postoperative Course and the Immune Response in Patient · Phase 2 · recruiting
NCT07355049 — The Effect of Dexmedetomidine Versus Lidocaine on Emergence Agitation. · NA · not yet recruiting

Other recruiting trials for Spasmodic Dysphonia

Currently open trials in the same condition.

NCT06561334 — Spasmodic Dysphonia Interviews · active not recruiting
NCT05150106 — Characterization of Clinical Phenotypes of Laryngeal Dystonia and Voice Tremor · recruiting
NCT05150093 — Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor · NA · recruiting
NCT05216770 — Understanding Disorder-specific Neural Pathophysiology in Laryngeal Dystonia and Voice Tremor · EARLY_PHASE1 · recruiting
NCT03042962 — Brain Networks in Dystonia · recruiting

Other Mayo Clinic trials

Trials by the same sponsor.

NCT07126548 — A Point of Prostate Cancer Diagnosis Virtual Reality Assistant Intervention in Supporting Newly Diagnosed Black Men · NA · not yet recruiting
NCT07221656 — Evaluation of Prolonged Asparaginase Activity Levels After Calaspargase Pegol Administration · not yet recruiting
NCT06891001 — The Utilization of a Shoe Insert on Individuals With Unilateral Greater Trochanteric Pain Syndrome on Single Leg Stance, · NA · not yet recruiting
NCT07169799 — Impact of Cryotherapy Spray (Tru-Freeze) for the Eradication of Gastric Antral Vascular Ectasia (ICE-GAVE) · NA · recruiting
NCT07086183 — Perioperative Risk in Patients on Chronic Aspirin Undergoing Craniotomy · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04648891 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mayo Clinic
Last refreshed: 23 May 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04648891.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing