Raltegravir (Isentress) Pilot Study in Relapsing Multiple Sclerosis (INSPIRE)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Baseline Versus Treatment Study to Determine the Efficacy of Raltegravir (Isentress) in Preventing Progression of Relapsing Remitting Multiple Sclerosis as Determined by Gadolinium-enhanced MRI|
- The number of new or recurrent Gd-enhancing lesions that appear on brain T1-weighted MRI [ Time Frame: Baseline and monthly until month 6 post baseline ] [ Designated as safety issue: No ]
- The cumulative number of new or enlarging T2 weighted lesions on brain MRI [ Time Frame: Baseline and monthly for 6 months ] [ Designated as safety issue: No ]
- Change in score on Multiple Sclerosis Functional Composite (MSFC) [ Time Frame: Baseline and monthly until month 6 ] [ Designated as safety issue: No ]
- Changes in Kurtzke Extended Disability Status Scale (EDSS) score [ Time Frame: Baseline and monthly to month 6 ] [ Designated as safety issue: No ]
- Cumulative number of Gd-T1 enhancing lesions [ Time Frame: At Baseline and monthly for 6 months ] [ Designated as safety issue: No ]
- Percent of subjects with scans free from enhancing lesions in Raltegravir treated subjects vs. baseline [ Time Frame: At baseline and monthly for 6 months ] [ Designated as safety issue: No ]
- Number of adverse events [ Time Frame: Continuously throughout the study ] [ Designated as safety issue: Yes ]This outcome will be assessed by blood, urine and saliva sampling; collection of patient reported symptoms and neurological and physical exams.
- Severity of adverse events [ Time Frame: Continuously throught the study ] [ Designated as safety issue: Yes ]This outcome will be assessed by blood, urine and saliva sampling; collection of patient reported symptoms and neurological and physical exams.
|Study Start Date:||April 2013|
|Study Completion Date:||September 2014|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.
400mg twice daily for 3 months
Other Name: Isentress
There is accumulating research evidence that Human Endogenous Retrovirus (HERV) and herpes viruses (in particular Epstein-Barr Virus) are involved in the pathogenesis of multiple sclerosis. People with active MS have higher levels of HERVs than people either without MS or who have other neurological conditions. It has been shown that HERVs may produce neurotoxic proteins/antigens associated with MS activity and disease progression. This is the first clinical trial investigating the hypothesis that the antiretroviral drug raltegravir may suppress HERV activity and ameliorate progression of relapsing remitting MS. Raltegravir is an integrase inhibitor which blocks retroviral replication. A recent experimental study suggests that raltegravir may also be active against herpes viruses.
Eligible participants (see Inclusion/Exclusion Criteria) will be observed for 3 months having monthly brain Gadolinium enhanced MRIs and blood/urine/saliva sampling (baseline). Then they will be treated with raltegravir (one 400mg pill taken twice a day) for 3 months. During treatment period participants will continue to have monthly MRIs and blood/saliva/urine sampling. Participants will have monthly clinical and neurological examinations and they will complete questionnaires assessing response to treatment. Participants will have screening and study visits at The Royal London Hospital, Whitechapel. Monthly MRIs will be performed at the Institute of Neurology at Queens Square, London.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01767701
|The Royal London Hospital|
|London, United Kingdom, E1 2AT|
|Principal Investigator:||Julian Gold, Prof||Queen Mary University of London|
|Principal Investigator:||Gavin Giovannoni||Queen Mary University of London|