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

NCT00501696 | Completed Phase 3 DMC

• 1 other identifier: H43034-30200-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• comparison of the mean score between treated and placebo groups, adjusting for differences in the baseline score between the two groups; comparison of each of the 10 scales of the MSQLI54 between treated and placebo groups

  17 weeks

Study Arms (2)

1

OTHER

A randomized placebo-controlled, parallel-group study, crossover-design

Drug: 4.5 mg Naltrexone; Drug: Naltrexone

2

OTHER

A randomized placebo-controlled, parallel-group study, crossover-design

Drug: 4.5 mg Naltrexone

Interventions

4.5 mg Naltrexone DRUG

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

Also known as: Naltrexon(4.5mg) or placebo , crossover-design

1; 2

Naltrexone DRUG

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

Also known as: Naltrexone(4.5mg) or placebo , crossover-design

1

Eligibility Criteria

• Age: 18 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

MS Center UCSF, Parnassus Ave, suite #908

San Francisco, California, 94117, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Naltrexone; Cross-Over Studies

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Bruce Kornyeyva, MD, PhD

  MS Center , UCSF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 12, 2007
• First Posted: July 16, 2007
• Study Start: February 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: May 19, 2008

Record last verified: 2007-02

Locations

US (1)