Efficacy of Cyclophosphamide Versus Methylprednisolone in Patients With Secondary Progressive Multiple Sclerosis (PROMESS)
Multiple Sclerosis, Chronic Progressive
About this trial
This is an interventional treatment trial for Multiple Sclerosis, Chronic Progressive focused on measuring Multiple Sclerosis, Chronic Progressive, Cyclophosphamide, Methylprednisolone, Randomized Controlled Trials, Double-Blind Study
Eligibility Criteria
Inclusion Criteria: Multiple sclerosis (MS) subjects (Mc Donald et al criteria), Aged 18 to 65 Diagnosis of secondary progressive MS ( Lublin and Reingold criteria) Progressive deterioration phase of at least 6 months and less than 4 years. Reduction of walking capacity and increase EDSS not ascribed to consequence of relapses (at least 0.5 point) in the last 12 months EDSS between 4.0 and 6.5 included Female participating must use contraceptives while on study drug Written informed consent Patient protected by French social security system Exclusion Criteria: Others diseases interfering with MS or treatment Recent history (within the previous 2 years) of drug or alcohol abuse. Patients with psychiatric illnesses who are unable to provide written, informed consent prior to any testing under this protocol Hemorrhagic cystitis Pregnant or lactating women Known allergy at cyclophosphamide, corticoids and in particular methylprednisolone Persistent infectious diseases Patients with bladder permanent catheterization Known history of cardiac arrhythmia after methylprednisolone intravenous treatment Abnormal screening/baseline blood tests exceeding any of the limits defined below : Hb < 9g/dl or Total white blood cell count less than 3 000/mm3 or lymphocytes count less than 900/ mm3 or Platelet count less than 125 000/mm3 Gastric or duodenal ulcer in evolution Gut diverticulosis Diabetes mellitus Known history of active hepatitis (ASAT >3 X ULN) Known history of renal failure (creatinine level > 180 µmol/L) Psychosis Current or past (< 3 months) participation in another drug trial Prior use of cyclophosphamide, lymphoid irradiation, monoclonal antibodies anti CD4 or anti CD52 or anti-VLA-4 therapies, cladribine ou cyclosporine A Other clinical types of MS : Secondary progressive phase evolving for more than 4 years ; Remittent type of MS without progression between relapses ; Primary progressive type of MS Use of interferon beta, methotrexate or imurel in the month prior to study. Treatment with intravenous monthly corticoids in the year prior to study. Treatment with corticoids (3 to 5 days) in the 2 month prior to study.
Sites / Locations
- CH de la Cote Basque
- CHU Besançon
- Hôpital Pellegrin, Département de neurologie
- CHU Caen
- Hôpital Gabriel Montpied
- AP HP Henri Mondor
- CHU Dijon
- CHU Lille Hôpital Salengro
- CHU Limoges
- GHICL Hôpital St. Philibert
- (CHU Lyon) Hôpital neurologique
- Hôpital La Timone
- (CHR Metz-Thionville) Hôpital Notre Dame de Bon Secours
- (CHU Montpellier), Hôpital de Gui de Chauliac
- CHU Nancy Hôpital central
- Hôpital Guillaume et René Laënnec
- CHU Nice Hôpital Pasteur
- (CHU Nîmes) Hôpital Caremeau
- Fondation Rothschild
- (AP HP) Hôpital Tenon
- Centre Hospitalier de Pau
- CHU de POISSY
- (CHU Reims) Hôpital Robert Debré
- CHU Ponchaillou
- CH d'Angoulême Girac
- (CHRU Starsbourg) Hôpital civil
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
1
2
Cyclophosphamide
Methylprednisolone