European Medicines Agency finalises update to Parkinson's disease guideline
The European Medicines Agency has published an update to its guidance for pharmaceutical companies developing medicines for Parkinson's disease.
The update to the guideline on clinical investigation of medicinal products in the treatment of Parkinson's disease, published today, covers how companies should design and carry out studies of medicines that aim to improve the disease's symptoms in patients and to modify the progress of the disease itself.
The update brings the guideline in line with recent scientific and medical developments in Parkinson's disease. It includes new information on the definition of newly diagnosed patients and updates to the criteria for including patients in clinical trials and statistical analyses.
The guideline was last published in 2008.
Parkinson's disease is a common neurological disease that tends to affect older people. It causes slowed movement, rigid muscles and problems with posture and usually gets worse over a number of years.
A number of medicines to treat the disease's symptoms are authorised, but there are currently no authorised medicines that have been shown to stop its progression.
The guideline is effective immediately. It is accompanied by a question-and-answer document giving more information on inclusion criteria explained in the updated guideline.
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- Guideline on clinical investigation of medicinal products in the treatment of Parkinson’s disease (06/07/2012)
- Questions and answers on additional clarification for inclusion criteria in the guideline on clinical investigation of medicinal products in the treatment of Parkinson’s disease revision 2 (06/07/2012)