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Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes

Phase 2
Waitlist Available
Research Sponsored by XTL Biopharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

To compare the efficacy of two dosages (600mg/day and 1200mg/day) of bicifadine SR with placebo for 14 weeks in reduction of chronic neuropathic patin (measured by a daily rating of pain intensity) associated with diabetic periperal neuropathy in adult outpatients. To compare the tolerability of two dosages of bicifadine SR with placebo in adult outpaitens treated for chronic neuropathic pain for 14 weeks associated with diabetic peripheral neuropathy.

Eligible Conditions
  • Diabetic Neuropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Drug: 2Experimental Treatment1 Intervention
Bicifadine
Group II: DrugExperimental Treatment1 Intervention
Bicifadine
Group III: ControlPlacebo Group1 Intervention
Placebo of Bicifadine

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Who is running the clinical trial?

XTL BiopharmaceuticalsLead Sponsor
3 Previous Clinical Trials
346 Total Patients Enrolled
Mark Roffman, PhDStudy DirectorXTL Bio
1 Previous Clinical Trials
250 Total Patients Enrolled
~18 spots leftby Dec 2025
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