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A randomized double-blind trial for the efficacy and safety of botulinum toxin type A combined with cobra neurotoxin in the treatment of trigeminal neuralgia

A randomized double-blind trial for the efficacy and safety of botulinum toxin type A combined with cobra neurotoxin in the treatment of trigeminal neuralgia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093034
Enrollment
Unknown
Registered
2024-11-27
Start date
2023-04-05
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Trigeminal neuralgia

Interventions

Coboteptin group:Snake venom neurotoxin treatment
Botulinum toxin group:Botulinum toxin treatment
Combination therapy group:Botulinum toxin treatment+Snake venom neurotoxin treatment

Sponsors

Second Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) meet the 2018 ICHD-3 diagnostic criteria for trigeminal neuralgia; 2) The pain site was the second and/or the third branch; 3) 75 years old>=age>=18 years old; 4) receiving no treatment or with poor response to current treatment; 5) signed informed consent.

Exclusion criteria

Exclusion criteria: 1) Hypersensitivity to botulinum toxin type A or cobra neurotoxin drugs; 2) combined neuromuscular diseases, such as myasthenia gravis, motor neuron disease; 3) complicated with severe liver and kidney dysfunction; 4) patients during pregnancy and lactation; 5) Medications that may damage the neuromuscular junction (e.g., aminoglycoside antibiotics, quinine) within one week prior to injection; 6) infection or fever at the injection site; 7) severe cognitive and psychiatric impairment; 8) glaucoma; 9) secondary trigeminal neuralgia, imaging examination showed space-occupying lesions; 10) Unwilling to cooperate to complete the relevant scales.

Design outcomes

Primary

MeasureTime frame
Visual analogue scale;Frequency of pain episodes;Onset of pain relief (> 50% decrease in VAS score from baseline);

Secondary

MeasureTime frame
response rate;Patient Global Impression of Changes;Hamilton Anxiety Scale;Hamilton Depression Scale;Pittsburgh Sleep Scale;

Countries

China

Contacts

Public ContactWeifeng Luo

Second Affiliated Hospital of Soochow University

lwfwxx@126.com+86 67784177

Outcome results

None listed

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