UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024055 |
|---|---|
| Receipt number | R000027642 |
| Scientific Title | Treatment of Lambert-Eaton myasthenic syndrome with 3,4-diaminopyridin |
| Date of disclosure of the study information | 2016/09/14 |
| Last modified on | 2018/03/19 10:08:24 |
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Basic information
Public title
Treatment of Lambert-Eaton myasthenic syndrome with 3,4-diaminopyridin
Acronym
Treatment of Lambert-Eaton myasthenic syndrome with 3,4-diaminopyridin
Scientific Title
Treatment of Lambert-Eaton myasthenic syndrome with 3,4-diaminopyridin
Scientific Title:Acronym
Treatment of Lambert-Eaton myasthenic syndrome with 3,4-diaminopyridin
Region
| Japan |
Condition
Condition
Lambert-Eaton myasthenic syndrome
Classification by specialty
| Neurology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Lambert-Eaton myasthenic syndrome(LEMS) is an uncommon autoimmune disease that is characterized by muscle weakness and dysautonomia. LEMS is a disorder of reduced acetylcholine release from the presynaptic nerve terminals. Antibodies directed against the voltage-gated calcium channel interfere with the normal calcium flux required for the release of acetylcholine. 3,4-diaminopyridine(3,4-DAP) is used to treat LEMS in European countries. The mechanism of action is a significant prolongation of the nerve terminal membrane depolarization, which enhances calcium entry and thereby improves the release of acetylcholine. The purpose of this study is to assess the effectiveness of 3,4-DAP in LEMS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The compound muscle action potential(CMAP) and the degree of increase in CMAP amplitude after high frequency receptive nerve stimulation conducted 1, 2, 4 months after treatment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
3,4-diaminopyridine
Interventions/Control_2
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who are electrically diagnosed to have Lambert-Eaton myasthenia syndrome or anti- voltage-gated calcium channel antibody positive patients.
Key exclusion criteria
Minors, pregnant women, or patients with a past history of epilepsy
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Wataru Sako |
Organization
Tokushima University
Division name
Department of Neurology
Zip code
Address
2-50-1, Kuramoto-Cho, Tokushima city, Tokushima prefecture
TEL
088-633-7207
dwsako@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Furukawa |
Organization
Tokushima University
Division name
Department of Neurology
Zip code
Address
2-50-1, Kuramoto-Cho, Tokushima city, Tokushima prefecture
TEL
088-633-7207
Homepage URL
tfurukawa@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Tokushima University
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
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
| 2016 | Year | 09 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 09 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | 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
| 2016 | Year | 09 | Month | 14 | Day |
Last modified on
| 2018 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027642
