A randomized, double-blinded, placebo-controlled, crossover study of 5-aminolevulinic acid in the prevention of migraine

A randomized, double-blinded, placebo-controlled, crossover study of 5-aminolevulinic acid in the prevention of migraine - Examination of the 5-aminolevulinic acid for the migraine

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019084

Enrollment

Registered

2015-10-01

Start date

2015-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Interventions

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. Participants

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Migraine

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
The number of migraine attacks [ Time Frame: every 4 weeks ]	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactYoshinaga Kajimoto

Osaka Medical College Department of neurosurgery

neu039@poh.osaka-med.ac.jp072-683-1221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026