MedTrace Logo

A Randomized Placebo-Controlled, Crossover-Design Study of the Effects of Low Dose Naltrexone

NCT00501696 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2008-05-19

No results posted yet for this study

Summary

This is a randomized placebo-controlled, parallel-group study, crossover-design of the effects of low dose naltrexone on the multiple sclerosis quality of life inventory (MSQLI54)

This study will assess the impact of LDN compared to placebo on quality of life as measured by the composite score of the MSQOL54 in adult subjects with MS.

Also we plan:

1. To compare the 10 scales of the MSQOL54 during the active treatment and placebo cycles between active treatment and placebo groups
2. To compare each individual's composite response to LDN versus placebo during the active treatment and placebo cycles
3. To compare each individual on the 10 scales of the MSQOL54 during the active treatment and placebo cycles

Conditions

Interventions

DRUG

4.5 mg Naltrexone

low dose naltrexone 4,5mg on the multiple sclerosis quality of life inventory (MSQLI54)

DRUG

Naltrexone

4,5mg low dose naltrexone on the multiple sclerosis quality of life inventory (MSQLI54)

Sponsors & Collaborators

Principal Investigators

  • Bruce Kornyeyva, MD, PhD · MS Center , UCSF

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00501696 on ClinicalTrials.gov