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comparison of topiramate and sodium valporate in migraine prophylaxis

A comparative study of the effects of low dose topiramate versus sodium valporate in migraine prophylaxis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT138802171856N1
Enrollment
56
Registered
2009-06-06
Start date
2009-05-31
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Condition 1: Common migraine. Condition 2: Classical migraine. Migraine without aura [common migraine] Migraine with aura [classical migraine]

Interventions

Intervention 1: Topiramate tablet 25 mg twice a day orally, for 12 months. Intervention 2: Sodium valporate tablets 200mg twice a day orally, for 12 months.
Treatment - Drugs
Topiramate tablet 25 mg twice a day orally, for 12 months
Sodium valporate tablets 200mg twice a day orally, for 12 months

Sponsors

Vice-chancellor for research, Kermanshah University of Medical Sciences and Health Services
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: more than 4 and less than 10 attacks monthly, patient age at onset of headache less than 50 years, patient’s age between 18-65 years, discontinuation of other prophylactic drugs one month prior to study, interval between attacks more than 48 hours Exclusion criteria: pregnancy and breast feeding, non-migraine headaches, overuse of medications in migraine attacks (consumption of NSAID, Ergots & Triptans more than 8 days a month), substance and alcohol abuse, illiteracy of patients and their family (unable to fill diaries)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Severity of headache. Timepoint: in each migraine attack. Method of measurement: patient will record the headache severity in daily notes as VAS (from 1 to 10) & physician registers them every 4 weeks.;Duration of migraine attack. Timepoint: in each migraine attack. Method of measurement: patient records the hours of headache in each attack , physician register them every 4 weeks.;Headache frequency. Timepoint: every 4 week. Method of measurement: According to patients daily notes.;Analgesic use. Timepoint: every 4 week. Method of measurement: According to patients daily notes.

Secondary

MeasureTime frame
Clinical side effects. Timepoint: every 4 weeks. Method of measurement: According to patients daily notes.;Blood cell count & liver function test changes. Timepoint: before and at the end of treatment course. Method of measurement: lab tests.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Dariush Afshari

Farabi hospital

dafshari@kums.ac.ir+98 83 1826 4512

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026