UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028778 |
|---|---|
| Receipt number | R000031769 |
| Scientific Title | Efficacy and safety of lacosamide in patients with erythromelalgia due to SCN9A gene mutation |
| Date of disclosure of the study information | 2017/08/23 |
| Last modified on | 2018/08/23 23:21:29 |
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Basic information
Public title
Efficacy and safety of lacosamide in patients with erythromelalgia due to SCN9A gene mutation
Acronym
Efficacy and safety of lacosamide in patients with erythromelalgia due to SCN9A gene mutation
Scientific Title
Efficacy and safety of lacosamide in patients with erythromelalgia due to SCN9A gene mutation
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Kenzo Takahashi |
Organization
University of the Ryukyus Hospital
Division name
Dermatology
Zip code
Address
207, Uehara, Nishihara-cho, Nakagamigun, Okinawa, Japan
TEL
098-895-1153
kenzot@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sayaka Yamaguchi |
Organization
University of the Ryukyus Hospital
Division name
Dermatology
Zip code
Address
207, Uehara, Nishihara-cho, Nakagamigun, Okinawa, Japan
TEL
098-895-1153
Homepage URL
sayaka-y@med.u-ryukyu.ac.jp
Sponsor or person
Institute
University of the Ryukyus Hospital
Institute
Department
Personal name
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)
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
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 |
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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 22 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031769
