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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031220681

Enrollment

Registered

2023-03-03

Start date

2023-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vocal fold paralysis vocal fold paralysis

Interventions

Inject trafermin into the vocal cords for vocal cord paralysis

bFGF

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Contacts

Public ContactTakao Goto

The University of Tokyo Hospital

gottytakao@gmail.com+81-3-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026