NCT00874198 - 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)

Boon AJ, Tans JT, Delwel EJ, Egeler-Peerdeman SM, Hanlo PW, Wurzer HA, Avezaat CJ, de Jong DA, Gooskens RH, Hermans J
Dutch normal-pressure hydrocephalus study: prediction of outcome after shunting by resistance to outflow of cerebrospinal fluid. J Neurosurg. 1997 Nov;87(5):687-93.
Hebb AO, Cusimano MD
Idiopathic normal pressure hydrocephalus: a systematic review of diagnosis and outcome. Neurosurgery. 2001 Nov;49(5):1166-84; discussion 1184-6. Review.
Kahlon B, Sundbärg G, Rehncrona S
Comparison between the lumbar infusion and CSF tap tests to predict outcome after shunt surgery in suspected normal pressure hydrocephalus. J Neurol Neurosurg Psychiatry. 2002 Dec;73(6):721-6.
Marmarou A, Black P, Bergsneider M, Klinge P, Relkin N; International NPH Consultant Group
Guidelines for management of idiopathic normal pressure hydrocephalus: progress to date. Acta Neurochir Suppl. 2005;95:237-40.
Tans JT, Poortvliet DC
Reduction of ventricular size after shunting for normal pressure hydrocephalus related to CSF dynamics before shunting. J Neurol Neurosurg Psychiatry. 1988 Apr;51(4):521-5.
Walchenbach R, Geiger E, Thomeer RT, Vanneste JA
The value of temporary external lumbar CSF drainage in predicting the outcome of shunting on normal pressure hydrocephalus. J Neurol Neurosurg Psychiatry. 2002 Apr;72(4):503-6.
Wikkelsö C, Andersson H, Blomstrand C, Lindqvist G, Svendsen P
Normal pressure hydrocephalus. Predictive value of the cerebrospinal fluid tap-test. Acta Neurol Scand. 1986 Jun;73(6):566-73.
Zemack G, Romner B
Adjustable valves in normal-pressure hydrocephalus: a retrospective study of 218 patients. Neurosurgery. 2002 Dec;51(6):1392-400; discussion 1400-2.

European Multicenter Study on the Prediction of Outcome in Patients With Idiopathic Normal Pressure Hydrocephalus

Details for clinical trial NCT00874198

Clinical trial NCT00874198 - References