Safety & Efficacy of Oxcarbazepine Monotherapy in Adults With Partial

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

See also
Status	Clinical Trial	Phase
Completed	`NCT01389596` - A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years	Phase 3
Completed	`NCT00275912` - Efficacy, Safety, and Tolerability of Oxcarbazepine Monotherapy in Children With Partial Seizures	Phase 4
Completed	`NCT01463306` - A 12-Month Study To Evaluate The Safety And Tolerability Of Pregabalin As Add-On Therapy In Pediatric Subjects 1 Month To 16 Years Of Age With Partial Onset Seizures And Pediatric And Adult Subjects 5 To 65 Years Of Age With Primary Generalized Tonic-Clonic Seizures	Phase 3

See also

Status

Clinical Trial

Phase

Completed

NCT01389596 - A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years

Phase 3

Completed

NCT00275912 - Efficacy, Safety, and Tolerability of Oxcarbazepine Monotherapy in Children With Partial Seizures

Phase 4

Completed

NCT01463306 - A 12-Month Study To Evaluate The Safety And Tolerability Of Pregabalin As Add-On Therapy In Pediatric Subjects 1 Month To 16 Years Of Age With Partial Onset Seizures And Pediatric And Adult Subjects 5 To 65 Years Of Age With Primary Generalized Tonic-Clonic Seizures

Phase 3

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

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.

NCT number	NCT00275925
Study type	Interventional
Source	Novartis
Contact
Status	Completed
Phase	Phase 4
Start date	December 2005
Completion date	March 2007

Safety and Efficacy of Oxcarbazepine Monotherapy in Adults With Partial Seizures

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms