Condition category
Nervous System Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Miss Ailsa Weatherall


Contact details

Clinical Research Centre
Royal London Hospital
2 Newark Street
E1 2AT
United Kingdom

Additional identifiers

EudraCT number

2012-004847-61 number

Protocol/serial number


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


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


Secondary study design

Non randomised controlled trial

Trial setting


Trial type


Patient information sheet


Topic: Neurological; Subtopic: Neurological (all Subtopics); Disease: Nervous system disorders


Raltegravir, open-label raltegravir 400mg twice daily; Follow Up Length: 6 month(s); Study Entry : Registration only

Intervention type



Not Specified

Drug names


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


Overall trial end date


Reason abandoned


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 MRI’s 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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Clinical Research Centre
E1 2AT
United Kingdom

Sponsor information


Queen Mary University of London (UK)

Sponsor details

R&D Office
Barts & London School of Medicine The QMI building
5 Walden Street
E1 2EF
United Kingdom

Sponsor type




Funder type


Funder name

Merck Sharp & Dohme Ltd. (MSD) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Publication citations

Additional files

Editorial Notes

26/08/2016: No publications found, verifying study status with principal investigator