UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019084 |
|---|---|
| Receipt number | R000022056 |
| Scientific Title | A randomized, double-blinded, placebo-controlled, crossover study of 5-aminolevulinic acid in the prevention of migraine |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2015/09/21 02:09:27 |
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Basic information
Public title
A randomized, double-blinded, placebo-controlled, crossover study of 5-aminolevulinic acid in the prevention of migraine
Acronym
Examination of the 5-aminolevulinic acid for the migraine
Scientific Title
A randomized, double-blinded, placebo-controlled, crossover study of 5-aminolevulinic acid in the prevention of migraine
Scientific Title:Acronym
Examination of the 5-aminolevulinic acid for the migraine
Region
| Japan |
Condition
Condition
Migraine
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effectiveness of the 5-aminolevulinic acid in migraine
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The number of migraine attacks
[ Time Frame: every 4 weeks ]
Key secondary outcomes
Severity and duration of migraine attacks [Time Frame: every 4 weeks]
(The intensity and duration of pain are evaluated by the headache diaries. The participants evaluate the pain intensity during an attack using a 1-3 scale. 1 is mild pain, 2 is moderate pain, and 3 severe pain.
Migraine symptoms, including aura, nausea, vomiting, light and sound sensitivity (They also assessed by headache diaries.)
Usage and dosage of rescue medication [Time Frame: every 4 weeks]
Migraine disability, as measured using the Migraine Disability Assessment (MIDAS) score at baseline and 3 and 7 months.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
Participants orally take 5-aminolevulinic acid phosphate (50mg) with sodium ferrous citrate (58mg) for 12 weeks.
After a 4-week washout, participants orally take placebo for 12 weeks.
Interventions/Control_2
Participants orally take placebo for 12 weeks.
After a 4-week washout, participants orally take 5-aminolevulinic acid phosphate (50mg) with sodium ferrous citrate (58mg) for 12 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Migraine
Key exclusion criteria
1. Individuals taking drugs or supplements influence to the migraine attacks.
2. Severe liver or renal impairment
3. Allergy to 5-aminolevulinic acid.
4. Severe systemic disorders, which need to medication.
5. Previous stroke or transient ischemic attack
6. Pregnancy or breastfeeding, including women trying to conceive
7. Porphyria and photosensitivity
8. History of alcohol or analgesic or psychotropic drug abuse
9. Those who already have entered another clinical trials.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinaga Kajimoto |
Organization
Osaka Medical College
Division name
Department of neurosurgery
Zip code
Address
2-7 Daigaku-Machi, Takatsuki city, Osaka, Japan
TEL
072-683-1221
neu039@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinaga Kajimoto |
Organization
Osaka Medical College
Division name
Department of neurosurgery
Zip code
Address
2-7 Daigaku-Machi, Takatsuki city, Osaka, Japan
TEL
072-683-1221
Homepage URL
http://www.osaka-med.ac.jp/deps/neu/class/index.html
neu039@poh.osaka-med.ac.jp
Sponsor or person
Institute
Department of neurosurgery, Osaka Medical college
Institute
Department
Personal name
Funding Source
Organization
SBI Pharmaceuticals Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
大阪医科大学附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | 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
| 2015 | Year | 09 | Month | 21 | Day |
Last modified on
| 2015 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022056
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
