Topiramate In Diabetic Polyneuropathy

Evaluation Of Topiramate Efficacy On Neuropathic Pain In Patients With Diabetic Polyneuropathy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016110330680N1

Enrollment

200

Registered

2017-02-04

Start date

2008-12-31

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

Diabetic Polyneuropathy. Diabetic polyneuropathy (E10-E14 with common fourth character .4+)

Interventions

Intervention 1: Group One(Intervention) All the selected patients are treated with Topiramate one hundred milligrams daily at night . Dose escalation is gradually over three weeks and patients are

Treatment - Drugs

Group One(Intervention) All the selected patients are treated with Topiramate one hundred milligrams daily at night . Dose escalation is gradually over three weeks and patients are evaluated by VA

Group Two (control),All patients treat by Gabapentin nine hundred milligrams daily divided in three hundred milligram every eight hour. Pain intensity is measured every two weeks for twelve weeks by

Eligibility

Sex/Gender

All

Age

35 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Age between 35t0 75 years old; painful diabetic polyneuropathy; more than 8 year duration of disease; Exclusion criteria: Pain due to other cause; Taking any other pain killer drugs; History of allergy to drugs; Do not meet the criteria of ethical committee of shahed University;

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Pain In Diabetic Polyneuropathy. Timepoint: In the beginning of study and then every two weeks to three months. Method of measurement: Questionnaire Completed By Researchers And International Standard Scale Of (VAS).	—

Secondary

Measure	Time frame
Drowsiness. Timepoint: Every two weeks. Method of measurement: Questionnaire Completed By researchers from patient complaints.;Redness or pruritus of skin(hypersensitivity to drugs). Timepoint: Two weeks after starting the study and then every two weeks for twelve weeks. Method of measurement: Questionnaire completed By researchers and question from patients.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSiamak Afshin majd

Associate Professor Of Neurology.Neurophysiology Research Center.Shahed University

afshin@shahed.ac.ir+98 21 8896 9438

Outcome results

None listed

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