Safety and Preliminary Evidence of Efficacy of Escalating Doses of Dimiracetam in AIDS Patients With Painful Neuropathy
Status:
Completed
Trial end date:
2010-03-01
Target enrollment:
Participant gender:
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
Phase:
Phase 2
Details
Lead Sponsor:
Neurotune AG
Collaborators:
Cross Research S.A. Triclinium clinical trial project managment LTD