INSPIRE (Isentress Pilot Study in Relapsing MS)

• Research type

  Research Study

• Full 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

• IRAS ID

  115968

• Contact name

  Gavin/G Giovannoni

• Sponsor organisation

  JRO Queen Mary Innovation Centre and Esst London NHS Foudation Trust

• Eudract number

  2012-004847-61

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  This exploratory study will enroll 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.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  12/EE/0544

• Date of REC Opinion

  10 Jan 2013

• REC opinion

  Further Information Favourable Opinion