The iMProveS trial is a 26 week, double blinded, randomized, placebo controlled phase IIa clinical study to investigate the safety, pharmacokinetics and efficacy of oral administration of two doses of odiparcil in patients 16 years and above with MPS type VI receiving enzyme replacement therapy (ERT). The study also has an open label arm with patients currently not on ERT. The trial will be recruiting patients at the end of the year.
During the trial patient’s GAG levels in the skin and white blood cells will be measured. Cardiac, pulmonary, ocular and audio function will be monitored and the mobility and pain of the patients assessed.
MPS type VI patients eligible to enroll must be
- 16 years of age or older
- Either currently receiving ERT or not have been on ERT for at least 3 months
- Patients can be located across Europe but must be willing to travel to the trial sites
iMProveS is a European trial with study centers, the Royal Free Hospital in London (UK) and Villa Metabolica in Mainz (Germany) with the participation of Dr. Derralynn Hughes and Prof. Dr. Julia Hennermann.
Patient travel logistics are supported by MPS Commercial Ltd.
Patient associations can be found in almost all countries where people are effected by MPS. A reference to national MPS societies can be found on the web site of the MPS Society (UK)