HTLV I Associated Myelopathy Clinical Trial
— HAM05Official title:
The HAM Ciclosporin Study : an Observational Trial of Therapy in Early or Progressing HAM/TSP
| Verified date | September 2021 |
| Source | Imperial College London |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
HAM/TSP is a chronic disease of the spinal cord, caused by a virus called HTLV-I. Worldwide approximately 20 million persons are infected.Infection with HTLV-I is lifelong, and about 3% of infected persons will develop this chronic debilitating disease, of which half will become wheelchair dependent. We, and others, have shown a strong and persistent immune response to HTLV-I in carriers and patients with HAM/TSP, but this fails to clear the virus. However, carriers with a low burden of virus in the blood have a low risk of developing disease. The immune response in these carriers seems better able to kill infected cells. A less efficient response is associated with a higher viral burden that drives the immune response with a resultant release of chemicals by the immune cells that inadvertently cause harm, most especially to cells in the spinal cord. Our understanding of HAM/TSP suggests that targeting the immune response should improve the health of our patients especially if the disease is diagnosed early. To identify the best type of treatment we are planning a series of studies of drugs that target the immune response in different ways. Each has been used in other inflammatory conditions but never before studied in HAM/TSP. We aim to study the extent and duration of the clinical response and to associate this with the different effects that the therapies have on the immune response and on the number of HTLV-I infected cells in the blood. This in turn will improve our knowledge and understanding of the disease and should lead to better therapy. This application is in relation to the first study - to explore that therapeutic benefit of ciclosporin in patients with HAM/TSP.
| Status | Completed |
| Enrollment | 7 |
| Est. completion date | January 2010 |
| Est. primary completion date | January 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years to 75 Years |
| Eligibility | Inclusion Criteria: - Early (less than 2 years) HAM - Progressing (within past 3 months) HAM - Important to study the effect of therapy on disease that is most active as most likely to detect and measure improvement Exclusion Criteria: - HIV infection - Tuberculosis, strongyloidiasis or other infection related to immune compromise - Hepatitis B & C viral infections - Malignancy |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | National Centre for Human Retrovirology | London |
| Lead Sponsor | Collaborator |
|---|---|
| Imperial College London | Imperial College Healthcare NHS Trust, Medical Research Council, University Hospital Birmingham |
United Kingdom,
Martin F, Castro H, Gabriel C, Adonis A, Fedina A, Harrison L, Brodnicki L, Demontis MA, Babiker AG, Weber JN, Bangham CR, Taylor GP. Ciclosporin A proof of concept study in patients with active, progressive HTLV-1 associated myelopathy/tropical spastic p — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Patient With Lack of Objective Clinical Improvement | Lack of objective clinical improvement after three months of therapy. Objective improvement was defined as any of the following comparing baseline measurements to 12, 24 and 48 weeks: i) one point decrease in the IPEC 1 scale (Instituto de Pesquisa Clínica Evandro Chagas), ii) >30% improvement in 10 m timed walk, iii) visual analogue pain score reduced by >2 points, iv) reduction of frequency or nocturia by greater than one or reduction of residual volume by more than 10% at two consecutive visits.
Proof of concept study and therefore outcomes report is descriptive only. No statistical test appropriate. |
up to 12 months | |
| Secondary | Change in Timed Walk Rank Between Baseline and 12 Weeks | Change in the time taken to walk 10 meters 0 - 12 weeks compared with baseline. A timed walk rank was created to take into account the use of walking aids.
Timed walk rank was calculated by ranking the time to walk 10 meters over all patients and visits, in the following order (highest/worst score to lowest/best score): unable to walk; able to walk, but not able to complete 10 meters (ranked on distance walked and time taken); able to walk 10 meters with a bilateral aid; able to walk 10 meters with a unilateral aid; able to walk 10 meters unaided (all ranked on time taken). Decrease in score means improvement. All evaluable patients were ranked on the time taken. There is no specific range for the rank scores. Upper and lower limits vary with the number of participants evaluated |
0, 12 weeks |