Protocol summary

Summary
(1) Objectives: evaluation of botulinum toxin efficacy on drooling of the patients with neurologic diseases (2) Design: Single central, Phase 2 trial (3) Setting and conduct: injection of 60 unit dysport in each submandibular gland plus injection of 120 unit dysport in each parotid gland under guide of sonography. Injection is performed in 2 sites of each parotid gland and one site in each submandibular gland. For evaluation of drooling, we count number of used handkerchief in one day. The handkerchiefs are given to the patient in 10th packages and then evaluated before injection and 6 and 12 weeks after injection (4) Participants including major eligibility criteria: 10 patients. Major inclusion criteria: any over 10 y/o patient with any neurologic disorder that suffers from sialorrhea.Exclusion criteria: Any neuromuscular junction disease, pregnancy or lactation period, History of any salivary gland tumor or inflammatory disease, infection of injection site (5) Intervention: injection of 60 unit dysport in each submandibular gland plus injection of 120 unit dysport in each parotid gland under guide of sonography (6) main outcome measures: salivation volume

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013110515289N1
Registration date: 2013-12-19, 1392/09/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-12-19, 1392/09/28
Registrant information
Name
Mojtaba Khademiyan ghadikolaee
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3012
Email address
khademiyan.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of botulinum toxin efficacy on drooling of the patients referring to neurology department of Ahvaz Golestan hospital
Public title
The effect of botulinum toxin on decrease of sialorrhea in patients with neurologic disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: between 10-85 years old patient with any neurologic disorder that suffers from sialorrhea Exclusion criteria: 1- Any neuromuscular junction disease 2-Pregnancy or lactation period 3-History of any salivary gland tumor or inflammatory disease 4-Infection of injection site
Age
From 10 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
None
Sample size
Target sample size: 10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Esfand St. Golestan Blv. Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Country
Iran (Islamic Republic of)
Postal code
61357-15794
Approval date
2013-01-07, 1391/10/18
Ethics committee reference number
Eth-681

Health conditions studied

1

Description of health condition studied
Sialorrhea
ICD-10 code
K11.7
ICD-10 code description
Disturbances of salivary secretion

Primary outcomes

1

Description
Severity of sialorrhea
Timepoint
Before injection-6 and 12 weeks after injection
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Dysport is an injection containing abobotulinumtoxinA (Botulinum toxin type A). AbobotulinumtoxinA is made from the bacteria that cause botulism. Dysport blocks the release of acetylcholine and a number of other neurotransmitters from synaptic vesicles. Inject of 120 unit dysport in each parotid gland and 60 unit dysport in each submandibular salivary gland.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
Mojtaba Khademiyan Ghadikolaee, MD
Street address
Nosrat St. Golestan Blvd. Golestan hospital
City
Ahvaz
Country
Iran (Islamic Republic of)

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mostafa Feghhi, MD
Street address
Esfand St. Golestan Blvd.
City
Ahvaz
Country
Iran (Islamic Republic of)
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mojtaba khademiyan ghadikolaee, MD
Position
Resident of Neurology
Other areas of specialty/work
Street address
Esfand St. Golestan Blvd.
City
Ahvaz
Country
Iran (Islamic Republic of)
Postal code
61357-15794
Phone
+98 61 1374 1093
Fax
+98 61 1336 1544
Email
khademiyan.m@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Seyed Ehsan Mohamadianinejad, MD
Position
Assistant Professor
Other areas of specialty/work
Street address
Esfand St. Golestan Blvd.
City
Ahvaz
Country
Iran (Islamic Republic of)
Postal code
61357-15794
Phone
+98 61 1374 3012
Fax
Email
Khademiyan.m@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mojtaba khademiyan ghadikolaee
Position
Resident of Neurology
Other areas of specialty/work
Street address
Esfand St. Golestan Blvd.
City
Ahvaz
Country
Iran (Islamic Republic of)
Postal code
15794-61357
Phone
+98 61 1374 1093
Fax
+98 61 1336 1544
Email
Khademiyan.m@ajums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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