Post-marketing surveillance of long term administration of Inovelon tablets in patients with Lennox-Gastaut syndrome (INO01T)

Study identification

• EU PAS number:
  EUPAS7225
• Study ID:
  28041
• Official title and acronym:
  Post-marketing surveillance of long term administration of Inovelon tablets in patients with Lennox-Gastaut syndrome (INO01T)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  Prospective, multicenter practice based post marketing surveillance study of patients with Lennox-Gastaut syndrome who have been prescribed Inovelon (rufinamide).
• Study status:
  Ongoing

Research institutions and networks

Institutions

Eisai

Study timelines

Date when funding contract was signed

Planned: 26/04/2013

Actual: 26/04/2013

Study start date

Planned: 26/04/2013

Actual: 26/04/2013

Date of final study report

Planned: 30/05/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eisai

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable