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Sponsored by: |
University of California, San Francisco |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00501696 |
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:
Condition | Intervention | Phase |
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Multiple Sclerosis |
Drug: 4.5 mg Naltrexone Drug: Naltrexone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
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) |
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 |
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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)
Drug: Naltrexone
4,5mg low dose naltrexone on the multiple sclerosis quality of life inventory (MSQLI54)
|
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)
|
Ages Eligible for Study: | 18 Years to 86 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
MS Center UCSF, Parnassus Ave, suite #908 | |
SAn Francisco, California, United States, 94117 |
Principal Investigator: | Bruce Kornyeyva, MD, PhD | MS Center , UCSF |
Responsible Party: | UCSF MS Center ( UCSF MS Center ) |
Study ID Numbers: | H43034-30200-02 |
Study First Received: | July 12, 2007 |
Last Updated: | May 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00501696 |
Health Authority: | United States: Institutional Review Board |
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Naltrexone Quality of Life |
Demyelinating Autoimmune Diseases, CNS Demyelinating diseases Sclerosis Autoimmune Diseases of the Nervous System |
Pathologic Processes Immune System Diseases Sensory System Agents Therapeutic Uses Physiological Effects of Drugs |
Narcotic Antagonists Nervous System Diseases Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions |