NCT01135251

Safety and Preliminary Evidence of Efficacy of Escalating Doses of Dimiracetam in AIDS Patients With Painful Neuropathy

A Double Blind, Parallel-group, Randomized Placebo Controlled, Multicentre Exploratory Study of Dimiracetam in Treatment Induced Painful Neuropathy in Patients With HIV Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Neurotune AG · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

One hundred consenting AIDS patients suffering from treatment induced painful neuropathy will be blindly randomize to Active and Placebo groups (ratio A/P = 3/2 and will receive increasing oral doses of dimiracetam starting from 400 mg b.i.d. and doubling the dose every two weeks until a maximum of 1600 mg b.i.d. Escalation to the the higher dose is allowed only if the previous dose did not cause tolerability problems. The highest reached dose will be maintained for a total of 8 week treatment. Patients must have a self evaluated pain of at least 4 on a 10 cm visual analog scale (VAS). Primary end point of the study will be the number of Adverse Events (AEs) reported in the placebo versus the active group. Preliminary evidence of efficacy will be sought by comparing active and placebo group as to the intensity of their pain at study onset and at study end. The pain will be evaluated by the VAS the Total Symptoms Score and the Clinical Global Impression

Conditions

• Neuropathy
• AIDS

Interventions

Type	Name	Description
DRUG	dimiracetam	400 mg capsules for oral use to be administered twice a day for a total of 8 weeks
DRUG	sugar pill	capsules containing 400 mg of inert material will be orally administered twice a day, one pill for 2 weeks, 2 pills for other 2 weeks and 4 pills for the last 4 weeks.

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2010-06-02
• Last updated: 2010-06-02

Locations

1 site across 1 country: South Africa