Clinical Trial Update on HAM/TSP

1) HAMLET-P: HTLV-1 Associated myelopathy/tropical spastic Paraparesis Multicentre Exploratory Double Blind Randomised Trial of Prednisolone (HAMLET-P).

This is a multi-centre international collaborative trial between Japan, Brazil, UK and USA. Japan Trial site has started recruitment. The primary aim of this multicenter international Phase II study is to identify whether or not steroids are an effective therapy in the treatment of HAM/TSP. A total of 48 or more patients will be recruited over the next 24 months at 6 Japanese trial cites. Ambulant adults with definite HAM/TSP categorised into one of the three different subtypes of HAM/TSP are recruited.

Arm A) A double blind placebo controlled trial of prednisolone vs placebo in patients with slow progressing HAM/TSP (Japan n=40). Patients receive treatment for 24 weeks and are followed up for a total of 48 weeks.

Arm B) Open label head to head comparison of oral prednisolone versus i.v. methylprednisolone in patients with rapidly progressing HAM/TSP (Japan n=8). Patients receive treatment for 24 weeks and are followed up for a total of 48 weeks.

Arm C) Non-interventional, observational study arm of patients with non-progressing HAM/TSP to collect collect the same immunological, virological and clinical data for 48 weeks in comparison to Arms A+B (as many as possible).

The primary outcome measure of Arms A + B is the change from baseline in 10-meter timed walk at 24 weeks, compared between different treatment groups. Secondary outcomes for all three studies will include clinical, safety, radiological, virological and immunological measures.

Further two clinical trials are currently recruiting in Japan only:

2) Anti-CCR4 antibody trial in HAM/TSP patients:

Ambulant HAM/TSP not responding to oral prednisolone treatment receive add on anti-CCR4 antibody treatment.

3) HAL- HAM/TSP:

Patients with advanced disability are provided with the exoskeleton robot suit termed HAL to improve mobility and rebuild muscle strength.