Evaluation of therapeutic effect of intracordal bFGF administration on vocal fold paralysis

Phase 2

Recruiting

• Conditions: vocal fold paralysis

• Registration Number: JPRN-jRCTs031220681
• Lead Sponsor: eha Rumi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-03
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

(1) Patients aged 18 years or older (regardless of gender)
(2) Patient diagnosed with unilateral vocal cord paralysis as a voice disorder
(3) As for vocal cord paralysis, patients who are not expected to recover due to the transection of the vagus nerve or recurrent nerve, or patients after 6 months of onset of paralysis
(4) Patients who wish to improve voice impairment due to vocal cord paralysis
(5) Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will based on a thorough understanding of the study

Exclusion Criteria

(1) Patients with obvious tumors on the vocal cords
(2) Patients with malignant tumors anywhere in the body (cancer-bearing condition)
(3) Patients with a history of malignant tumor on the vocal cords
(4) Patients with a history of severe drug allergies or side effects
(5) Patients with a history of hypersensitivity to trafermin (genetical recombination)
(6) Pregnant, lactating, or possibly pregnant patients
(7) Patients who are judged inappropriate for participation in this study by the principal investigator or co-investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of cases with improvement of 5 points or more in VHI-10 score after 180 days of administration from baseline

Secondary Outcome Measures

Name	Time	Method
1) Change in VHI-10 (before administration, 30, 90, and 180 days after administration)<br>2) Change in MPT (before administration, 30, 90, and 180 days after administration)<br>3) Change in auditory impression (GRBAS scale) (before administration, 30, 90, and 180 days after administration)<br>4) Change in mean expiratory flow rate (MFR) during vocalization (before administration, 30, 90, and 180 days after administration)<br>5) Change in acoustic analysis data (before administration, 30, 90, and 180 days after administration)<br>6) Vocal cord shape (atrophy), vocal cord movement (before administration, 30, 90, and 180 days after administration)<br>7) Insufficiency of glottal closure, amplitude, wave, phase difference (before administration, 30, 90, and 180 days after administration)