The HAM Ciclosporin Study: An observational trial of therapy in early or progressing HAM/TSP - HAM Ciclospori

Phase 1

• Conditions: HTLV-I-associated myelopathy

• Registration Number: EUCTR2006-002031-24-GB
• Lead Sponsor: Imperial College

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-05-05
• Study Completion: 2010-01-29
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 7

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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified