UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061371 |
|---|---|
| Receipt number | R000070219 |
| Scientific Title | Triptans and lasmiditan in patients with migraine attacks associated with neurodevelopmental disorders |
| Date of disclosure of the study information | 2026/04/24 |
| Last modified on | 2026/04/24 15:50:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Triptans and lasmiditan in patients with migraine attacks associated with neurodevelopmental disorders
Acronym
Triptans and lasmiditan in patients with migraine attacks associated with neurodevelopmental disorders
Scientific Title
Triptans and lasmiditan in patients with migraine attacks associated with neurodevelopmental disorders
Scientific Title:Acronym
Triptans and lasmiditan in patients with migraine attacks associated with neurodevelopmental disorders
Region
| Japan |
Condition
Condition
patients with migraine attacks accompanied by neurodevelopmental disorders
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Triptans and lasmiditan are considered specific acute medications for migraine attacks. Despite the efficacy of these treatments, continuation of these medications was limited because some patients experienced adverse effects. A previous study reported a close association between migraine and neurodevelopmental disorders. The present study investigated triptans and lasmiditan in the treatment of consecutive patients with migraine attacks accompanied by neurodevelopmental disorders.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
2-h pain relief and 2-h pain-free rate and adevese events
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
Triptan and/or lasmiditan tablets were prescribed for consecutive patients after the diagnosis of migraine attacks and neurodevelopmental disorders. Triptans, eletriptan or zolmitriptan was prescribed. However, in this study, lasmiditan was used at a dose of 50 mg because the 100 mg dose led to greater adverse effects in Japanese patients.
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
All patients were diagnosed with migraine by a certified headache specialist according to the International Classification of Headache 3rd edition. For all patients, brain magnetic resonance imaging was performed, and other organic lesions causing headache were eliminated. Before this study, neurodevelopmental disorders were diagnosed by several specialists.
Key exclusion criteria
Patients who could not express their headaches and the effect of the drugs.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Shibata |
Organization
University of Tsukuba, Mito Medical Center, Mito Kyodo General Hospital
Division name
Department of Neurosurgery/Headache Clinic
Zip code
3100015
Address
Mito, Ibaraki, 310-0015, Japan
TEL
029-231-2371
yshibata@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Shibata |
Organization
University of Tsukuba, Mito Medical Center, Mito Kyodo General Hospital
Division name
Department of Neurosurgery/Headache Clinic
Zip code
3100015
Address
Mito, Ibaraki, 310-0015, Japan
TEL
029-231-2371
Homepage URL
yshibata@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba, Mito Medical Center, Mito Kyodo General Hospital
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba, Mito Medical Center, Mito Kyodo General Hospital
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba, Mito Medical Center, Mito Kyodo General Hospital
Address
Mito, Ibaraki, 310-0015, Japan
Tel
029-231-2371
yshibata@md.tsukuba.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
| 2026 | Year | 04 | Month | 24 | 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
16
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2026 | Year | 04 | Month | 24 | Day |
Last modified on
| 2026 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070219
