Central Nervous System


For approximately the last 10 years, the design and conduct of studies and entire development programs with central nervous system (CNS) drugs has been a major area of ICON’s activities. ICON’s CNS experience comprises global and regional studies in all major areas of psychiatry, neurology, and pain research, all phases of clinical drug development, and all core services for planning, conducting, evaluating and reporting such projects.

This includes program and protocol development, regulatory consultancy, study management, medical monitoring and pharmacovigilance, central laboratory services, data management, statistical evaluation and medical writing.

In recent years, ICON has been involved in clinical studies and programs in the following CNS indications/areas:

Psychiatry

  • Anxiety Disorders (GAD, Panic Disorder, Social Phobia)
  • Major Depressive Disorder (MDD)
  • Bipolar Disorders (Acute Mania and Bipolar Depression. Prevention-of-Relapse Studies
  • Schizophrenia and Schizoaffective Disorders (Treatment of active-phase, acutely psychotic subjects; treatment of symptomatically stable patients, including patients with negative symptoms and cognitive dysfunction
  • Pediatric Psychiatry – Attention Deficit Hyperactivity Disorder (ADHD), Down Syndrome, Pediatric Depression

Neurology

  • Alzheimer’s Disease (mild, moderate, severe degrees of severity)
  • Parkinson’s Disease
  • Huntington’s Disease
  • Friedreich’s Ataxia
  • Multiple Sclerosis (Relapsing Remitting MS, Secondary Progressive MS)
  • Epilepsy (partial and generalized seizures)
  • Migraine (acute treatment, prophylaxis)
  • Sleep Disorders (primary and secondary insomnias, hypersomnias)

Pain Research

  • Neuropathic Pain – Postherpetic and diabetic neuropathy (in collaboration with ICON’s experts in the relevant disease areas)
  • Malignant Pain (in collaboration with ICON’s Oncology Therapeutic Area Group)
  • Fibromyalgia

CNS Therapeutic Area Group (TAG)

ICON has a major group of project managers and CRAs with CNS experience. In order to ensure up-to-date knowledge and high quality, these teams are trained, supported and advised by ICON’s CNS Therapeutic Area Group (TAG). The CNS TAG is comprised of international specialists qualified in psychiatry, neurology, psychopharmacology, or psychology and/or with extensive operational experience in CNS studies. The TAG is responsible for therapeutic oversight, gives input into feasibility projects, strategic planning of country and site distribution of projects, and provides Medical Monitor services. The TAG is available for consulting service, identification of Key Opinion Leaders, and the set up of advisory boards.