IRCT20090613002027N21
Recruiting
Phase 2
Evaluation of the efficacy and safety of the addition of lacosamide to duloxetine in the treatment of taxanes- induced peripheral neuropathy: a randomized double-blind placebo-controlled trial
ConditionsTaxane-induced neuropathy.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Taxane-induced neuropathy.
- Sponsor
- Mazandaran University of Medical Sciences
- Enrollment
- 60
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •People aged 18 years and older
- •Patients with taxane\-induced peripheral neuropathy
- •Existence of moderate to severe neuropathic pain with PI\-NRS score \=4
- •Normal baseline ECG
Exclusion Criteria
- •Patients with a history of neurological diseases such as hereditary or acquired neuropathies
- •Patients with neuropathic pain due to conditions such as post\-herpes neuralgia, uncontrolled diabetes with neuropathy, trigeminal neuralgia, spinal cord injury or other neurological diseases, known vitamin B12 deficiency, amyloidosis, neuromuscular diseases and connective tissue diseases
- •Creatinine clearance less than 30 ml / min
- •Severe liver failure
- •History of allergy to lacosamide or duloxetine
- •History of duloxetine or lacosamide use
- •Evidence of severe systemic disease
- •patients with epilepsy
- •Drugs that interact with the study drugs including tricyclic antidepressants (TCAs), norepinephrine\-specific serotonin reuptake inhibitors (SNRIs), and sodium channel blockers in the past three months
- •Use of monoamine oxidase inhibitors (MAOIs) in the last fourteen days or simultaneously
Outcomes
Primary Outcomes
Not specified
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