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

Sponsor:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00501696

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:

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

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:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

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

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 February 09, 2012