NCT02341092 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Bayen E, Pradat-Diehl P, Jourdan C, Ghout I, Bosserelle V, Azerad S, Weiss JJ, Joël ME, Aegerter P, Azouvi P; Steering Committee of the PariS-TBI study
Predictors of informal care burden 1 year after a severe traumatic brain injury: results from the Pari
Fugate LP, Spacek LA, Kresty LA, Levy CE, Johnson JC, Mysiw WJ
Measurement and treatment of agitation following traumatic brain injury: II. A survey of the Brain Injury Special Interest Group of the American Academy of Physical Medicine and Rehabilitatio
Osiurak F, Jarry C, Allain P, Aubin G, Etcharry-Bouyx F, Richard I, Bernard I, Le Gall D
Unusual use of objects after unilateral brain damage: the technical reasoning model. Cortex. 2009 Jun;45(6):769-83. doi: 10.1016/j.cortex.2008.06.013. Epub 2008 Nov
Saoût V, Gambart G, Leguay D, Ferrapie AL, Launay C, Richard I
Aggressive behavior after traumatic brain injury. Ann Phys Rehabil Med. 2011 Jun;54(4):259-69. doi: 10.1016/j.rehab.2011.04.003. Epub 2011 May 5. English, French.

AVEC-TC : Post-traumatic Behavioral Disorders : Analysis and Valuation of the Expertise of Use of the Close Relations of People Victims of Traumatic Brain Injury

Details for clinical trial NCT02341092

Clinical trial NCT02341092 - References