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

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Naltrexone

Criteria

Inclusion Criteria:

• Clinically definite MS by current International Criteria

• Between 18 and 75 years of age

• Willingness to not change or start disease modifying or symptomatic therapies of MS during the trial

• The patient should be able to understand English

• The patients should read, understand and sign the study informed consent form prior to any participation in the study

• Patients currently on a disease modifying therapy should be on this medication for at least 3 months and not anticipate changing or discontinuing this medication during the 17 week study

• Patients not currently on a disease modifying therapy

• For women of childbearing potential, willingness to use a barrier method of contraception during the trial

Exclusion Criteria:

• Start of a disease modifying therapy within 3 months of entry in the trial

• Planned start of DMT during the clinical trial

• Pregnancy

• Current chronic opioid agonists use, i.e. any narcotic medication including hydroxycode and codeine-containing preparations

• Patients under 18 years of age

• Patients older than 75 years prior to the start of therapy

• Patients who are currently on both interferon and glatiramer acetate

• Patients who are currently taking LDN

• Patients who are currently taking immunosuppressive medications e.g. cyclophosphamide, mitoxantrone, azathioprine, methotrexate, mycophenolate mofetil, natalizumab, rituximab, alemtuzumab or other immune suppressants

• Participation in other clinical treatment trials in MS

• The patients who cannot comprehend MSQLI54 instructions and