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

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ClinicalTrials.gov Identifier: NCT00501696
Recruitment Status : Completed
First Posted : July 16, 2007
Last Update Posted : May 19, 2008
Sponsor:
Information provided by:
University of California, San Francisco

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. 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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: 4.5 mg Naltrexone Drug: Naltrexone Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Placebo-Controlled, Crossover-Design Study of the Effects of Low Dose Naltrexone on Quality of Life as Measured by the Multiple Sclerosis Quality of Life Inventory (MSQLI54)
Study Start Date : February 2007
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
1
A randomized placebo-controlled, parallel-group study, crossover-design
Drug: 4.5 mg Naltrexone
low dose naltrexone 4,5mg on the multiple sclerosis quality of life inventory (MSQLI54)
Other Name: Naltrexon(4.5mg) or placebo , crossover-design

Drug: Naltrexone
4,5mg low dose naltrexone on the multiple sclerosis quality of life inventory (MSQLI54)
Other Name: Naltrexone(4.5mg) or placebo , crossover-design

2
A randomized placebo-controlled, parallel-group study, crossover-design
Drug: 4.5 mg Naltrexone
low dose naltrexone 4,5mg on the multiple sclerosis quality of life inventory (MSQLI54)
Other Name: Naltrexon(4.5mg) or placebo , crossover-design




Primary Outcome Measures :
  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 [ Time Frame: 17 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 86 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00501696


Locations
United States, California
MS Center UCSF, Parnassus Ave, suite #908
SAn Francisco, California, United States, 94117
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Bruce Kornyeyva, MD, PhD MS Center , UCSF

Responsible Party: UCSF MS Center
ClinicalTrials.gov Identifier: NCT00501696     History of Changes
Other Study ID Numbers: H43034-30200-02
First Posted: July 16, 2007    Key Record Dates
Last Update Posted: May 19, 2008
Last Verified: February 2007

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents