Status:
COMPLETED
Efficacy of Cyclophosphamide Versus Methylprednisolone in Patients With Secondary Progressive Multiple Sclerosis
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Multiple Sclerosis, Chronic Progressive
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Preliminary not-controlled clinical studies of the efficacy of monthly intravenous cyclophosphamide administration in secondary progressive multiple sclerosis reported encouraging results, but no rand...
Detailed Description
Background Preliminary not-controlled clinical studies of the efficacy of monthly intravenous cyclophosphamide administration in secondary progressive multiple sclerosis reported encouraging results,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT00241254
Start Date
December 1 2005
End Date
March 1 2012
Last Update
March 15 2012
Active Locations (26)
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1
CH de la Cote Basque
Bayonne, France, 64109
2
CHU Besançon
Besançon, France, 25030
3
Hôpital Pellegrin, Département de neurologie
Bordeaux, France, 33076
4
CHU Caen
Caen, France, 14033