HTLV-I-associated myelopathy
Conditions
Interventions
Trade Name: Neoral 10mg and 50mg soft gelatin capsules
Product Name: Ciclosporin
Product Code: Ciclosporin
Pharmaceutical Form: Capsule*
Sponsors
Imperial College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Have ‘definite’ HAM/TSP that is either early or progressing disease as defined below Are able to give informed consent Are 16 years or older “HAM/TSP” Patients with HAM/TSP will be included if they fulfil the criteria of “Definite HAM/TSP” as agreed in Belem 2003. See annex. “Early HAM/TSP” Less than 2 years history of disease, excluding the duration of bladder symptoms if these were the original and only presenting symptoms as assessed by history. Must have motor disability (minimum of stiffness or weakness). “Progressing HAM/TSP” New or worsening (must be current within 3 months) motor symptoms in a patient with symptoms of greater than 2 years duration. Including a documented deterioration in timed walk by 50%. Patients with new symptoms under follow up could be included immediately. New patients presenting for initially with symptoms > 2 yrs would be eligible upon review if progression according to these criteria were met. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Hepatitis B or hepatitis C infection HIV infection Badly controlled hypertension (BP diastolic > 95 mmHg) Overt sepsis Prior exposure to corticosteroids (other than 3 days courses of pulsed methylprednisolone) or other immunomodulating therapy for HAM/TSP or within 2 years if not for HAM/TSP Active TB (untreated or on treatment) Strongyloides stercoralis (untreated)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine in an open, pilot, proof of principle study whether ciclosporin A improves the clinical measures of patients with ‘early’ or ‘progressing’ ‘definite’ HAM/TSP; Secondary Objective: To determine in patients with HAM/TSP the safety of ciclosporin A the effect of ciclosporin A on viral load and expression the effect of ciclosporin A on markers of activation and proliferation To explore the mechanism of pathogenesis of HAM/TSP by understanding the effect of ciclosporin A on the severity and progression of HAM/TSP ; Primary end point(s): 1. Incidence of clinical failure at 48 weeks. 2. Time to clinical failure (Kaplan-Meier) Clinical Failure will be defined as any one of the following three: 1. Lack of any objective improvement (timed walk, spasticity, bladder function or pain) after three months of therapy 2. 1 point deterioration in the IPEC scale (an scale designed for the assessment of disability in patients with HAM) compared with baseline (2 separate measurements) at any time. 3. 30% deterioration in timed walk compared with baseline (2 separate measurements) at any time. | — |
Countries
United Kingdom
Outcome results
None listed