Evaluating the modulatory effect of bometanide on increased irritability and associated neurophysiological symptoms in ALS patients.
Design
Patients are randomly assigned in a 1:1 ratio to groups of bumetanide or placebo by use of a block randomisation scheme. With the 95 % confidence level, power set at 80%, and a potential attrition rate of 10%, the sample size required to detect differences is 11 for each group
Settings and conduct
This interventional and therapeutic study is performed on patients with ALS in Firoozgar Hospital. Patients in the bumetanide group will take 2 mg of bometanide twice daily for 3 month, and patients in the placebo group will receive a placebo in the same way, and its effects will be evaluated through MUNIX and ALSFRS-R tests. All stages of the trial and patient information and the results will be blind to physicians, researchers, patients and the information analysis team until the end of the statistical analysis.
Participants/Inclusion and exclusion criteria
Inclusion criteria: aged 18 to 80 years. able to swallow tablets/capsules. slow vital capacity (SVC) greater than or equal to 50%
Exclusion criteria: having kidney or liver dysfunction. history of laryngeal spasm. dystonia. and akathisia. history of neurological disease
Intervention groups
In the bumetanide group, 2 mg of bumetanide was administered twice daily for 3 months, and patients in the placebo group received placebo in the same way. All patients were visited weekly to monitor their symptoms, neurological and physical function.
Main outcome variables
Decrease in muscle spasticity of patients and increase ALSFRS-R test score
General information
Reason for update
Acronym
ALS
IRCT registration information
IRCT registration number:IRCT20201020049089N1
Registration date:2020-12-15, 1399/09/25
Registration timing:prospective
Last update:2020-12-15, 1399/09/25
Update count:0
Registration date
2020-12-15, 1399/09/25
Registrant information
Name
Mohsen Sedighi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2578
Email address
sedighi.mo@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of bometanide on spasticity in patients with ALS
Public title
Evaluating the effect of bumetanide on ALS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. No history of other neurological diseases such as stroke and dementia
2. No orthopedic problems
3. Not having diabetes. addiction. hepatitis
4. The patient's education level at least up to the fifth grade
Exclusion criteria:
1. Lack of cooperation of the patient during testing and exercises
2. Failure to refer the patient for the second stage tests after the interventions
3. Patients whose diet is changed.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, ALS patients referred to the medical center were randomly divided into two groups of bometanid and placebo using a randomized block design with two blind strains in a ratio of 1: 1. All the identity and medical information of the participants in the two groups will be covered on all the researchers until the end of the study and statistical analysis of the study results.
Blinding (investigator's opinion)
Double blinded
Blinding description
All participants and their caregivers, clinicians, researcher and data analysts will be blinded to treatment assignments until final data analysis.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat highway
City
Tehran
Province
Tehran
Postal code
14665354
Approval date
2020-11-22, 1399/09/02
Ethics committee reference number
IR.IUMS.REC.1399.904
Health conditions studied
1
Description of health condition studied
Amyotrophic lateral sclerosis
ICD-10 code
G12.21
ICD-10 code description
Amyotrophic lateral sclerosis
Primary outcomes
1
Description
MUNIX and ALSFRS-R
Timepoint
Before and after intervention
Method of measurement
ALSFRS-R questionnaire and electromyogram device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, ALS patients will be treated with bometanid at a dose of 2 mg every 12 hours as an oral tablet for 3 months.
Category
Treatment - Drugs
2
Description
Control group: In this group, ALS patients will be treated with placebo for 3 months, which is completely similar to bometanide in terms of appearance such as shape and color and will be taken orally every 12 hours.