Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424931
Status:
COMPLETED
Last Update Posted:
2014-05-23
First Post:
2007-01-19
Brief Title:
A Safety and Effectiveness Study of a Single Dose of JNJ-17216498 in Patients With Narcolepsy
Sponsor:
Alza Corporation DE USA
Organization:
Alza Corporation DE USA
Study Overview
Official Title:
A Phase II Randomized Double-blind Double-dummy Placebo and Comparator-controlled Parallel Group Multi-Center Study to Investigate the Safety and Efficacy of a Single Dose of JNJ-17216498 Administered to Subjects With Narcolepsy
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of JNJ-17216498 compared to modafinil and placebo in patients with narcolepsy with and without cataplexy
Detailed Description:
This study with a new experimental drug is being done to assess safety and tolerability and to explore effectiveness in the treatment of narcolepsy Approximately 64 adult patients with narcolepsy with or without cataplexy will be recruited for the study Patients who meet study criteria will need to stop taking their current narcolepsy and or other medication for at least 14 days before checking into the site for 3 nights They will be randomly assigned to one of 4 treatment arms each patient has an equal chance of receiving placebo 10 mg JNJ-17216498 50 mg JNJ-17216498 or 400 mg modafinil Placebo has no active drug Modafinil is a drug currently approved to treat narcolepsy Patients will take the medication on only one day and will receive study medication in a blinded fashion ie the patient the doctor and the study sponsor will not know what group the patient is in until all patients complete the study The investigator and the sponsor will monitor the study for the occurrence of possible side effects In addition to a screening visit and the three nights at the site there will be a follow-up visit 7-10 days after the day the study drug is taken After the follow-up visit patients may resume their previous narcolepsy medications Medical history physical examination vision tests blood pressure heart rate temperature and ECGs will be checked periodically Blood samples will be taken for standard safety laboratory tests as well as for the measurement of the drug blood level The Maintenance of Wakefulness Test will be done to assess the patients ability to resist falling asleep while reclining in a dark quiet room this will involve completing 7 sessions before dosing and 10 sessions after dosing Patients will have two polysomnograms a test of brain muscle and eye activity during sleep obtained by recording brain waves and other activities such as muscle and eye movement Polysomnograms will be obtained overnight once before and once after dosing Patients will also complete brief questionnaires about their sleepiness and the status of their narcolepsy throughout the study Patients will receive capsules containing either 10 mg JNJ-17216498 50 mg JNJ-17216498 400 mg modafinil andor placebo on one day Seven capsules will be taken orally in the morning and two capsules will be taken orally in the afternoon Placebo contains no active drug Modafinil is a drug currently approved to treat narcolepsy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| C-2006-028 | None | None | None |