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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026150
Receipt No. R000028606
Scientific Title Safety and efficacy of mexiletine hydrochroride in spinal and bulbar muscular atrophy (SBMA) :a multicenter, randomised, double-blind, placebo-controlled trial
Date of disclosure of the study information 2017/03/31
Last modified on 2018/08/20

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Basic information
Public title Safety and efficacy of mexiletine hydrochroride in spinal and bulbar muscular atrophy (SBMA) :a multicenter, randomised, double-blind, placebo-controlled trial
Acronym Mexiletine in SBMA
Scientific Title Safety and efficacy of mexiletine hydrochroride in spinal and bulbar muscular atrophy (SBMA) :a multicenter, randomised, double-blind, placebo-controlled trial
Scientific Title:Acronym Mexiletine in SBMA
Region
Japan

Condition
Condition Spinal and Bulbar Muscular Atrophy
Classification by specialty
Medicine in general Neurology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To evaluate efficacy and safety of mexiletine hydrochrolide in the patients with SBMA
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Change of the difference in distal latencies between under room temperature and cold exposure at 4 weeks
Key secondary outcomes (1)Quantitative muscle strength of upper limbs (grip power, pinch power, ten seconds test)
(2)Peripheral nerve conduction studies (distal latency, compound muscle action potential, motor nerve conduction velocity, sensory nerve conduction velocity, area, duration time, Harvey-Masland test, skin temperature)
(3)Motor function test (tongue pressure, timed walk test, modified QMG score)
(4)Pulmonary function test (vital capacity, forced vital capacity, forced expiratory volume, peak expiratory flow and V50/V25, flow-volume curve)
(5)ADL scales (ALSFRS-R, SBMAFRS)
(6)QOL scales (36-Item Short Form Health Survey, The Individualised Neuromuscular Quality of Life questionnaire, Interactive Voice Response System)
(7)Lean mass evaluation by Dual-energy X-ray Absorption
(8)Blood examinations (creatine kinase, aldolase, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, testosterone)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Mexiletine Hydrochloride 300mg daily, for 4 weeks
Interventions/Control_2 placebo for 4 weeks
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male
Key inclusion criteria 1. Male Patients whose number of the CAG repeat in the androgen receptor gene is 38 or more
2. Patients with muscle weakness due to lower motor neuronal loss (bulbar palsy or extremity palsy)
3. Patients with muscle weakness or myotonia under cold exposure
4. Patients are between 20 and 80 years old at the time of the agreement acquisition
5. Patients who are capable of ambulatory hospital visits
6. Patients whose hepatic and renal functions meet the following criteria:
Serum AST,ALT: <4.0 * Upper Limit of Institutional Reference Value
Serum creatinine: <1.5 * Upper Limit of Institutional Reference Value
7. Patients with written informed consent
Key exclusion criteria 1. Patients who have hypersensitivity for this medicine
2. Patients who have second degree atrioventricular block, third degree atrioventricular block, or left bundle branch block
3. Patients who show Brugada-type ECG
4. Patients who have past history of myocardial infarction, valvular disease, or cardiomyopathy
5. Patients whose heart rate is 50 /min or less
6. Patients who have severe liver or renal dysfunction
7. Patients who have heart failure
8. Patients whose systolic blood pressure is 90mmHg or less
9. Patients who have parkinsonism
10. Patients whose serum potassium level is 3.5mEq/l or less
11. Patients who take anti-arrhythmic drug
12. Patients who take anti-epileptic drug
13. Patient who have neurological disorders except for SBMA
14. Patients whose HbA1c(NGSP) level is 6.5% or more
15. Patients who take hypoglycemic drugs
16. Patients who are alcohol addicts
17. Patients who are drug addicts
18. Patients who take cimetidine, rifampicin, or theophylline
19. Patients who have severe complication
20. Patients whose grip power of dominant hand is less than 10kg
21. Patients who are judged to be inappropriate to participate in the trial by any other reasons
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahisa Katsuno
Organization Nagoya University Graduate School of Medicine
Division name Department of Neurology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya city 466-8550, Japan
TEL 052-744-2385
Email ka2no@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Yamada
Organization Nagoya University Graduate School of Medicine
Division name Neurology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya city 466-8550, Japan
TEL 052-744-2390
Homepage URL
Email s.yamada@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 03 Month 31 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 No longer recruiting
Date of protocol fixation
2017 Year 02 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 02 Month 15 Day
Last modified on
2018 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028606

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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