UMIN-CTR Clinical Trial

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
Email	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
Email	skoba66@fmu.ac.jp

Sponsor
Institute	Fukushima Medical University
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005708