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Evaluation of the effect of low-dose naltrexone in patients with Trigeminal Neuralgia and Chronic migraine patients

Clinical Trial on the efficacy of low dose naltrexone vs placebo on pain intensity in Trigeminal Neuralgia and Chronic migraine patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20171109037332N2
Enrollment
40
Registered
2022-04-19
Start date
2022-05-22
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

Condition 1: Trigeminal Neuralgia. Condition 2: Chronic Migraine. Trigeminal neuralgia Chronic migraine without aura

Interventions

Intervention 1: Intervention group 1: First two weeks of placebo and then eight weeks of low-dose naltrexalone (4.5 mg) will be given. In the low-dose placebo and naltrexalone phases, the capsules are

Sponsors

Kerman University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: According to ICHD3 criteria, they are diagnosed with TN or chronic headache. Be over 18 years old Have the necessary cooperation to participate in the study.

Exclusion criteria

Exclusion criteria: Patient non-cooperation The patient is pregnant or breastfeeding. If the patient uses opioid analgesics or inhales opioids If the patient regularly uses anti-inflammatory drugs. Known allergy or reaction to naltrexone If the patient consumes alcohol and can not refrain from consuming it during the study. The patient has rheumatic or autoimmune diseases The patient has been diagnosed with a mental illness that disrupts his or her collaboration in the study.

Design outcomes

Primary

MeasureTime frame
Low-dose naltrexone, chronic migraine, trigeminal neuralgia. Timepoint: Before the intervention and every day during the intervention. Method of measurement: VAS questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHoma Kamyabi

Kerman University of Medical Sciences

h.kamyabi1244@gmail.com+98 34 3211 9028

Outcome results

None listed

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