UMIN-CTR Clinical Trial

Basic information
Public title	Facial nerve regeneration surgery using fibroblast growth factor in Bell's palsy and Hunt syndrome
Acronym	Facial nerve regenerating surgery for Bell's palsy and Hunt syndrome
Scientific Title	Facial nerve regeneration surgery using fibroblast growth factor in Bell's palsy and Hunt syndrome
Scientific Title:Acronym	Facial nerve regenerating surgery for Bell's palsy and Hunt syndrome
Region	Japan

Condition
Condition	Bell's palsy and Hunt syndrome
Classification by specialty	Medicine in general Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy and safety of facial nerve regenerating surgery with bFGF for Bell's palsy and Hunt syndrome
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Non-recovery rate at 12 months after disease onset. Recovery is defined as an improvement of the House-Brackmann facial grading score 1-2.
Key secondary outcomes	Non-recovery rate at 6 months after disease onset, incidence rate of sequelae at 12 months after disease onset. Postoperative bleeding which needs hemostasis in operating room and audiometric threshold elevation using air conduction pure tone audiometry at 250 Hz, 500 Hz, 1 kHz, 2 kHz, and 4 kHz test frequencies

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	In intervention group: Facial nerve regenerating surgery with human recombinant bFGF (Fiblast spray, Kaken Pharmaceutical CO., Tokyo, Japan) via gelatin hydrogel.
Interventions/Control_2	In control group: Transmastoid conventional facial nerve decompression surgery
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Adult severe Bell's palsy and Hunt syndrome patients, who are older than 15 years, complete facial palsy(10 or less yanagihara score), degree of denervation exceeding 90% with ENoG and clinical follow unavailable for more than 12 month
Key exclusion criteria	The exclusion criteria are (1) pregnancy, (2) current neoplasms, (3) chronic kidney disease, (4) chronic liver disease, (5) immune-suppression (6) opt out decompression surgery
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Naohito Middle name Last name Hato
Organization	Ehime University
Division name	Department of Otolaryngology Head and Neck surgery
Zip code	791-0295
Address	Shitsukawa, Toon city, Ehime Prefecture
TEL	0899605366
Email	nhato@m.ehime-u.ac.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Fujiwara
Organization	Ehime University
Division name	Otolaryngology Head and Neck Surgery
Zip code	791-0295
Address	Shitsukawa, Toon city, Ehime
TEL	0899605366
Homepage URL
Email	t.fujiwarabi@gmail.com

Sponsor
Institute	Department of Otolaryngology Head and Neck Surgery, Ehime University
Institute
Department

Funding Source
Organization	Department of Otolaryngology Head and Neck Surgery, Ehime University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board,Ehime University Hospital
Address	Shitsukawa, Toon, Ehime
Tel	089-960-5172
Email	rinri@m.ehime-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 26 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 01 Month 26 Day
Date of IRB	2014 Year 09 Month 22 Day
Anticipated trial start date	2015 Year 01 Month 26 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 01 Month 26 Day
Last modified on	2019 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018954