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

ISRCTN	ISRCTN82487767
DOI	https://doi.org/10.1186/ISRCTN82487767
EudraCT/CTIS number	2012-004847-61
ClinicalTrials.gov number	NCT01767701
Secondary identifying numbers	14731

Submission date: 22/08/2013
Registration date: 22/08/2013
Last edited: 19/08/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Ailsa Weatherall
Scientific

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

Email	ailsa.weatherall@bartshealth.nhs.uk

Study information

Study design	Non-randomised; Interventional; Design type: Not specified, Treatment
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Study acronym	INSPIRE: Raltegravir in Relapsing MS
Study objectives	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(s)	12/EE/0544; First MREC approval date 10/01/2013
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Raltegravir
Primary outcome measure	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 study start date	30/04/2013
Completion date	31/01/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	55 Years
Sex	Both
Target number of participants	Planned Sample Size: 24; UK Sample Size: 24
Total final enrolment	31
Key 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
Key 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.
Date of first enrolment	30/04/2013
Date of final enrolment	31/01/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Clinical Research Centre

London
E1 2AT
United Kingdom

Sponsor information

Queen Mary University of London (UK)
University/education

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

"ROR"	https://ror.org/026zzn846

Funders

Funder type

Industry

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Date added	Peer reviewed?	Patient-facing?
Basic results	21/06/2019	No	No
Basic results	19/08/2019	No	No
HRA research summary	28/06/2023	No	No

Editorial Notes

19/08/2019: ClinicalTrials.gov number added. Added ClinicalTrials.gov link to basic results (scientific).
21/06/2019: Added clinicaltrialsregister.eu link to basic results (scientific). Added total final enrollment.
26/08/2016: No publications found, verifying study status with principal investigator