Phase 3 study on Amyotrophic Lateral Sclerosis (ALS)2019-04-08T11:33:46+00:00

Project Description

Phase 3 study on Amyotrophic Lateral Sclerosis (ALS)

Brief

Amyotrophic lateral sclerosis (ALS) is a neurological disease caused by advanced neurodegeneration of motor cortical neurons and the frontal horn of the spinal cord. The symptoms are major motor disorders (intensification of refunds, spasticity) and peripheral neuropathy (cramps, muscle weakness, and advanced muscle degeneration).

R.G.L has been mandated by a biotechnology company to lead an international and competitive phase 3 study in Israel to prove the safety of their molecule in ALS.

Goals

  • To find 3 medical centers with a high rate of patients recruitment,
  • To sign with all 3 centers a Clinical Trial Agreement and negotiate a budget per patient according to Sponsor’s guidelines and recommendations,
  • To obtain Local Ethical Committee approvals in the conduct of the Trial,
  • To obtain Ministry of Health’s approval in the conduct of the Trial for Israel, 
  • To recruit at least 50% of the recruitment patient potential (100 patients) on 12 months,

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