UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004795 |
|---|---|
| Receipt number | R000005708 |
| Scientific Title | Treatment of Lambert-Eaton myasthenic syndrome with 3,4-diaminopyridin |
| Date of disclosure of the study information | 2011/01/04 |
| Last modified on | 2019/11/13 23:28:01 |
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Basic information
Public title
Treatment of Lambert-Eaton myasthenic syndrome with 3,4-diaminopyridin
Acronym
Treatment of LEMS with diaminopyridin
Scientific Title
Treatment of Lambert-Eaton myasthenic syndrome with 3,4-diaminopyridin
Scientific Title:Acronym
Treatment of LEMS with diaminopyridin
Region
| Japan |
Condition
Condition
Lambert-Eaton myasthenic syndrome
Classification by specialty
| Medicine in general | Pneumology | Neurology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Lambert-Eaton myasthenic syndrome (LEMS) is a neuroimmunological condition, in which autoantibodies to calcium channels cause myasthenia and dysautonomia. It often accompanies lung cancer, particularly small cell carcinoma. 3,4-diaminopyridine (DAP) is known to enhance cholinergic transmission at the neuromuscular junction and used to treat LEMS in western countries. The present study aims to treatment LEMS with 3, 4 DAP.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Neurological findings, Barthel Index, compound motor action potentials and waxing rate on nerve conduction studies 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who are histopathologically diagnosed as lung cancer.
2) Patients who are electrically diagnosed to have Lambert-Eaton myasthenic syndrome.
3) Patients who are informed of their diagnosis.
4) Patients who do not have history of seizure or epilepsy.
5) Patients who agreed to participate in the present study by written informed consent.
Key exclusion criteria
Patients who are not able to comprehend the aim of the present study due to brain metastasis or metabolic encephalopathy are excluded.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Ugawa |
Organization
Fukushima Medical University
Division name
Department of Neurology
Zip code
Address
1 Hikarigaoka , Fukushima-shi, Fukushima-ken
TEL
024-547-1248
ugawa-tky@umin.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Kobayashi |
Organization
Fukushima Medical University
Division name
Department of Neurology
Zip code
Address
1 Hikarigaoka , Fukushima-shi, Fukushima-ken
TEL
024-547-1248
Homepage URL
skoba66@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
MHLW
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
福島県立医科大学付属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 04 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2010 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 27 | Day |
Last modified on
| 2019 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005708
