UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of lacosamide in patients with erythromelalgia due to SCN9A gene mutation
Title of the study (Brief title)	Efficacy and safety of lacosamide in patients with erythromelalgia due to SCN9A gene mutation
Region	Japan

Condition
Condition	erythromelalgia
Classification by specialty	Neurology Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Erythromelalgia is a clinical syndrome characterized by erythematous swelling and burning sensation mostly affecting lower extremities evolved by the elevated skin temperature. These complaints are partly relieved by the cooling with ice-cold water. One familial type of erythromelalgia is known to be caused by a mutation of the SCN9A gene that encodes a voltage-gated sodium channel. Lacosamide is an anti-epileptic medicine, which inactivates that type of the voltage-gated sodium channel, thus, it can be credited with this type of familial erythromelalgia. This study is aimed to evaluate the efficacy and safety of administration of lacosamide to patients with erythromelalgia caused by SCN9A mutation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Amount of change in scoring below 8 weeks after starting lacosamide administration Pain Intensity Numerical Rating Scale Daily sleep interference scale
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	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The administration of lacosamide is started on 50 mg/day, the dose is increased by 50 mg/ day each week until 200 mg/day for a maintenance dose. It can be increased up to 400 mg / day without side effect. The assessment of efficacy is done after 8 weeks.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	A case of erythromelalgia due to SCN9A gene mutation.
Key exclusion criteria	A case with kidney dysfunction A case with significant ECG abnormality A Case who is considered by doctor to be inappropriate for administration of lacosamide.
Target sample size	1

Research contact person
Name of lead principal investigator	Kenzo Takahashi
Organization	University of the Ryukyus Hospital
Division name	Dermatology
Address	207, Uehara, Nishihara-cho, Nakagamigun, Okinawa, Japan
TEL	098-895-1153
Email	kenzot@med.u-ryukyu.ac.jp

Public contact
Name of contact person	Sayaka Yamaguchi
Organization	University of the Ryukyus Hospital
Division name	Dermatology
Address	207, Uehara, Nishihara-cho, Nakagamigun, Okinawa, Japan
TEL	098-895-1153
Homepage URL
Email	sayaka-y@med.u-ryukyu.ac.jp

Sponsor
Institute	University of the Ryukyus Hospital
Institute
Department

Funding Source
Organization	University of the Ryukyus Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	琉球大学医学部附属病院（沖縄県）

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 23 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 08 Month 22 Day
Anticipated trial start date	2017 Year 08 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 22 Day
Last modified on	2018 Year 08 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031769