UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029085 |
|---|---|
| Receipt number | R000033267 |
| Scientific Title | Clinical trial of 3,4-diaminopyridine(3,4-DAP) for the Lambert-Eaton myasthenic syndrome |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2023/09/19 08:50:29 |
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Basic information
Public title
Clinical trial of 3,4-diaminopyridine(3,4-DAP) for the Lambert-Eaton myasthenic syndrome
Acronym
Clinical trial of 3,4-diaminopyridine(3,4-DAP) for the Lambert-Eaton myasthenic syndrome
Scientific Title
Clinical trial of 3,4-diaminopyridine(3,4-DAP) for the Lambert-Eaton myasthenic syndrome
Scientific Title:Acronym
Clinical trial of 3,4-diaminopyridine(3,4-DAP) for the Lambert-Eaton myasthenic syndrome
Region
| Japan |
Condition
Condition
Lambert-Eaton myasthenic syndrome(LEMS)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To check the safety and efficacy of 3,4-DAP for LEMS patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of Manual Muscle Testing(MMT) and Hand grasping power
Key secondary outcomes
Improvement of repetitive stimulation test findings
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-DAP
Period from consent this trial to correspond the stop criteria
Dose 15-80mg/day
number of dose three times a day
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
| 15 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. The patients who receive a diagnosis of the Lambert-Eaton myasthnic syndrome
2. In the patients who administer anti-cholinesterase drug, there are no obvious improvement of clinical manifestation and EMG findings within 2 weeks.
3. The patients that an agreement is provided in this clinical trial.
Key exclusion criteria
1. serum anti-acetylcholie receptor antibody positive
2. serum anti-MuSK antibody positive
3. pregnancy
4. epilepsy
5. iver dysfunction
6. renal dysfunction
7. abnormal ECG findings
8. the patient who judged inappropriate from the doctor
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Ikeda |
Organization
Gunma university graduate school of medicine
Division name
neurology
Zip code
371-8511
Address
showa-machi 3-39-22, maebashi-city, gunma, Japan
TEL
027-220-8061
ikeday006@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuaki |
| Middle name | |
| Last name | Nagashima |
Organization
Gunma university hospital
Division name
neurology
Zip code
371-8511
Address
showa-machi3-39-15, maebashi-city, gunma, Japan
TEL
027-220-8538
Homepage URL
nagakazu@gunma-u.ac.jp
Sponsor or person
Institute
Gunma university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Gunma university graduate school of medicine
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
Gunma university hospital
Address
showa-machi3-39-15, maebashi-city, gunma, Japan
Tel
027-220-8740
gunmaciiu-office@umin.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
| 2017 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
nagakazu@gunma-u.ac.jp
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
1
Results
The study was terminated because the target number of participants was not reached and the study was not evaluable.
Results date posted
| 2023 | Year | 09 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with Lambert-Eaton syndrome
Participant flow
One person entered, but there were no more participants after that.
Adverse events
none
Outcome measures
We could not evaluate due to lack of participants.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | 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
| 2017 | Year | 09 | Month | 11 | Day |
Last modified on
| 2023 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033267
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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