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

NCT01135251 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2010-06-02

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Cross Research S.A.

    collaborator INDUSTRY

  • Triclinium clinical trial project managment LTD

    collaborator UNKNOWN

  • Neurotune AG

    lead INDUSTRY

Principal Investigators

  • Ruggero G Fariello, MD FAAN · Neurotune AG

  • Daniel R Malan, MD · Triple Research, Port Elizabeth SA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • South Africa

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01135251 on ClinicalTrials.gov