Design Module

Design Module

The Design Module contains detailed information about the study design, including study type, allocation methods, intervention models, masking information, primary purpose, enrollment details, and biospecimen information. This module provides essential details about how the clinical trial is structured and conducted.

Design Module path is as follows:

Study -> Protocol Section -> Design Module

Design Module


Ignite Creation Date: 2025-12-24 @ 10:58 PM
Ignite Modification Date: 2025-12-24 @ 10:58 PM
NCT ID: NCT02221869
Study Type: INTERVENTIONAL
Allocation: RANDOMIZED
Primary Purpose: TREATMENT
Study: NCT02221869
Study Brief: A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy
Protocol Section: NCT02221869
Bio Specs (If Any):
Design Masking Infos (If Any):

Design Masking Infos

Design Masking Brief View
None View
Design Observational Models (If Any):
Design Time Perspectives (If Any):
Design Who Masked (If Any):
Enrollment Infos (If Any):

Enrollment Infos

Enrollment Type Enrollment Count View
ACTUAL 106 View
Expanded Access Types (If Any):
Phases (If Any):

Phases

Phase Brief Phase Text View
None PHASE3 View