Contact information
Type
Scientific
Primary contact
Miss Ailsa Weatherall
ORCID ID
Contact details
Clinical Research Centre
Royal London Hospital
2 Newark Street
London
E1 2AT
United Kingdom
-
ailsa.weatherall@bartshealth.nhs.uk
Additional identifiers
EudraCT number
2012-004847-61
ClinicalTrials.gov number
Protocol/serial number
14731
Study information
Scientific 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
Acronym
INSPIRE: Raltegravir in Relapsing MS
Study hypothesis
This exploratory study will enrol patients with active MS lesions will be enrolled in a baseline versus treatment clinical trial where they will be observed for 3 months, having monthly Gd-enhanced brain MRI, blood, saliva and urine collection and neurological assessments and then treated with active open-label raltegravir (400mg twice daily) and followed up with monthly Gd-enhanced brain MRI, blood, saliva and urine collection and neurological assessments for a further for 3 months.
Ethics approval
12/EE/0544; First MREC approval date 10/01/2013
Study design
Non-randomised; Interventional; Design type: Not specified, Treatment
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Topic: Neurological; Subtopic: Neurological (all Subtopics); Disease: Nervous system disorders
Intervention
Raltegravir, open-label raltegravir 400mg twice daily; Follow Up Length: 6 month(s); Study Entry : Registration only
Intervention type
Drug
Phase
Not Specified
Drug names
Raltegravir
Primary outcome measures
Gadolinium enhanced MRI; Timepoint(s): MRI every 4 weeks from day 0 to day 168
Secondary outcome measures
Not provided at time of registration
Overall trial start date
30/04/2013
Overall trial end date
31/01/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients between 18-55 years of age.
2. Diagnosis of MS, according to the revised McDonald Criteria 2010.
3. EDSS score of 0-6.0 inclusive.
4. Documented at least one relapse within the past 12 months or at least one Gd-enhanced lesion on the brain MRI detected within 3 months prior to screening date.
5. Gd-enhanced lesion on screening MRI if MRI not used to meet screening criteria above.
6. Female patients of childbearing potential will be expected to be on appropriate contraception (hormonal or barrier method of birth control; abstinence) from time of consent until 6 weeks after treatment discontinuation. (the repeated administration of gadolinium and MRI are not recommended during pregnancy). NOTE: Subjects are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
7. Females of childbearing potential must have a negative urine pregnancy test prior to every MRI scan/ within 7 days prior to being registered for protocol therapy.
8. Must give written informed consent and authorize the release and use of protected health information, as required by local law.
9. Able and willing to undergo blood, saliva and urine sampling at regular intervals as defined by the protocol.
10. Able and willing to receive Gadolinium enhanced MRIs at regular intervals as defined by the protocol.
11. Able to comply with study requirements.
Target Gender: Male & Female; Upper Age Limit 55 years ; Lower Age Limit 18 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 24; UK Sample Size: 24
Participant exclusion criteria
1. Pregnant or breastfeeding or unwilling to use contraception.
2. Treatment with immunosuppressive, immunomodulatory or experimental treatments within the last 6 months of enrolment in the study, but excluding pulsed intravenous or oral steroids for treatment of MS relapse.
3. No pulsed intravenous or oral steroids in the 30 days preceding the baseline assessment.
4. Patients presenting with medical disorder deemed severe or unstable by the CI such as poorly controlled diabetes or arterial hypertension, severe cardiac insufficiency, unstable ischemic heart disease, abnormal liver function tests (>2.5 times ULN) and abnormal complete blood count (in particular leukopenia, as defined by a lymphocyte count <500, neutrophil <1.5 or platelet count < 100, or thrombocytopenia < 1.5 LLN), or any medical condition which, in the opinion of the chief investigator, would pose additional risk to the patient.
5. Presence of human immunodeficiency virus antibodies.
6. Patients receiving proton pump inhibitors (e.g. omeprazole/esomeprazole)
7. Patients with active hepatitis B or/and C with liver function tests >2.5 times ULN.
8. Exposure to any other investigational drug within 30 days of enrolment in the study.
9. Prior history of malignancy unless an exception is granted by the Chief Investigator.
10. History of uncontrolled drug or alcohol abuse within 6 months prior to enrolment into the study.
11. Patients treated with Rifampicin in past four weeks.
Recruitment start date
30/04/2013
Recruitment end date
31/01/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clinical Research Centre
London
E1 2AT
United Kingdom
Funders
Funder type
Industry
Funder name
Merck Sharp & Dohme Ltd. (MSD) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary