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

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00501696
First received: July 12, 2007
Last updated: May 15, 2008
Last verified: February 2007
  Purpose

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 Intervention Phase
Multiple Sclerosis
Drug: 4.5 mg Naltrexone
Drug: Naltrexone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: February 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 86 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: UCSF MS Center
ClinicalTrials.gov Identifier: NCT00501696     History of Changes
Other Study ID Numbers: H43034-30200-02
Study First Received: July 12, 2007
Last Updated: May 15, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 22, 2014