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| Sponsors and Collaborators: |
Imperial College London Medical Research Council, Clinical Trials Unit, London, UK Selly Oak Hospital, Birmingham, UK St. Mary's Hospital, London, UK |
|---|---|
| Information provided by: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT00773292 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HTLV I Associated Myelopathy |
Drug: ciclosporin |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | The HAM Ciclosporin Study : an Observational Trial of Therapy in Early or Progressing HAM/TSP |
| Enrollment: | 7 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | October 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
ciclosporin: Experimental
48 weeks treatment with ciclosporin
|
Drug: ciclosporin
Ciclosporin 2.5 - 5mg/kg/day in two equally divided doses. dose adjusted according to trough ciclosporin concentration
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This is a proof of concept, open, observational study of Ciclosporin for the treatment of HTLV−I−associated myelopathy in patients with less than 2 years disease or new evidence of progression. After two baseline assessments patients will be commenced on ciclosporin in a weight dependent dose (2.5 − 5mg/kg/day) and the dose adjusted according to plasma drug concentrations. Participants will be monitored on a further 11 occassion as per the schedule every 2 − 8 weeks (less frequent with time) by self−administered questionnaires relating to quality of life and spasticity, by regular assessment of pain, timed walk, spasticity, bladder and bowel function and by blood tests to ensure the safety of the therapy. Blood samples will also be collected, at the same time points, for investigation of the immune response to HTLV−I and the quantity and activity of the virus. At 5 key time points the participants will undergo a more detailed neurological examination, the spinal cord will be imaged by MRI before, once during (12 weeks) and at the completion of the study and the fluid that bathes the brain (CSF) will be examined before and after 12 weeks of therapy. Therapy is planned for 12 months with 6 months further follow−up but therapy will be continued or discontinued according to clinical response.
Eligibility| Ages Eligible for Study: | 16 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United Kingdom | |
| National Centre for Human Retrovirology | |
| London, United Kingdom, W2 1NY | |
| Principal Investigator: | Graham P Taylor | Imperial College London |
More Information
| Responsible Party: | Imperial College London ( Dr Graham P Taylor ) |
| Study ID Numbers: | Cro423 |
| Study First Received: | October 15, 2008 |
| Last Updated: | October 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00773292 |
| Health Authority: | United Kingdom: Medicines and Health Devices Regulatory Authority |
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HAM/TSP |
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Spastic paraparesis Cyclosporine Spinal Cord Diseases Clotrimazole Miconazole Tioconazole Paraparesis, Tropical Spastic Central Nervous System Diseases Paraparesis, Spastic |
Cyclosporins Virus Diseases Central Nervous System Infections Myelitis HTLV-I Infections Paraparesis Retroviridae Infections Tropical Spastic Paraparesis |
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Anti-Infective Agents RNA Virus Infections Molecular Mechanisms of Pharmacological Action Immunologic Factors Nervous System Diseases Physiological Effects of Drugs Central Nervous System Viral Diseases Enzyme Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Antifungal Agents Therapeutic Uses Deltaretrovirus Infections Antirheumatic Agents Dermatologic Agents |
