MINORYX THERAPEUTICS CLINICAL STUDY FOR MALE PATIENTS WITH AMN
Minoryx Therapeutics are recruiting patients for a clinical study to evaluate the efficacy of a new drug called MIN-102. It is hoped this drug will demonstrate a positive effect on the progression of AMN symptoms.
To ensure the study measures the effectiveness of the new drug accurately, it is necessary for some participants to receive a placebo. For this study, two thirds of the participants will be given the active drug and one third a placebo. To further ensure accuracy the study is also double-blind, meaning that neither the patient nor their consultant will know if they are taking the active drug or the placebo. However, in case of a medical emergency the treatment allocation can be immediately identified.
The study will be conducted in both Europe and the US for a duration of two years beginning in September 2017 and is open to European and US patients residing in Germany, Italy, France, Hungary, Spain, The Netherlands and the UK according to the inclusion criteria below. Patients from other European countries should contact us regarding the possibility of inclusion in the study.
- Males only
- 18 to 65 years old
- Confirmed diagnosis of adrenoleukodystrophy (ALD)
- Clinical evidence of adrenomyeloneuropathy (AMN) symptoms assessed according to the EDSS scale. (Those with a score between 2 and 6 will be accepted onto the trial; participants should be able to walk for six minutes (with or without rest) using their usual walking aids.)
- Well-managed or no Addison’s Disease.
- Either willingness to use contraception or sexual abstinence for the duration of the study, or total abstinence.
- Diabetes types 1 or 2
- Previous bone marrow transplant
- Biotin (MD-1003) unless discontinued at least three months before participating in this trial
- Lorenzo’s Oil, unless the dose has been kept stable for at least 6 months prior to participating in this trial, and is kept constant during the trial
There are numerous other exclusion criteria based on MRI scan results, current treatments and studies for ALD/AMN as well as pre-existing conditions. These should all be discussed with the recruiting consultant to assess suitability for the study.
If you are interested in participating in this study and would like further details on how to enrol please do not hesitate to contact us.
To read the press release from Minoryx Therapeutics click here.