A Safety and Effectiveness Study of a Single Dose of JNJ-17216498 in Patients With Narcolepsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alza Corporation, DE, USA
ClinicalTrials.gov Identifier:
NCT00424931
First received: January 19, 2007
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Narcolepsy
Drug: JNJ-17216498
Drug: Modafinil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Alza Corporation, DE, USA:

Primary Outcome Measures:
  • Explore the effectiveness of JNJ-17216498 in patients with narcolepsy as determined by the Maintenance of Wakefulness Test done throughout the study. [ Time Frame: ·To explore efficacy of JNJ-17216498 in patients with narcolepsy with or without cataplexy up through 48 hours after dosing. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Explore the safety and tolerability of JNJ-17216498 in patients with narcolepsy by assessing adverse events, vital signs, laboratory results, vision tests, physical exam and ECGs. [ Time Frame: To explore the safety and tolerability of JNJ-17216498 in patients with narcolepsy with or without cataplexy throughout the study. ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: January 2007
Study Completion Date: December 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
JNJ-17216498 10mg one time
Drug: JNJ-17216498
10mg one time
Experimental: 002
JNJ-17216498 50mg one time
Drug: JNJ-17216498
50mg one time
Active Comparator: 003
Modafinil 200 mg X 2
Drug: Modafinil
200 mg X 2

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, i.e. 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 patient's 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 and/or 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of narcolepsy within the past 5 years
  • good general health
  • no history or presence of drug or alcohol abuse

Exclusion Criteria:

  • current use of prescription or over the counter medications including asprin or herbal supplements with the exception of acetaminophen (Tylenol)
  • use of fluoxetine (Prozac) in the past 6 weeks
  • use of Xyrem in the past 4 weeks
  • use of tobacco products in the past 3 months
  • caffeine consumption that is more than 5 cups of tea, or 3 cups of coffee or 8 cans of soda per day
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424931

Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
Tucson, Arizona, United States
United States, California
San Diego, California, United States
Stanford, California, United States
United States, Florida
Spring Hill, Florida, United States
St Petersburg, Florida, United States
United States, Georgia
Macon, Georgia, United States
United States, Indiana
Danville, Indiana, United States
Fort Wayne, Indiana, United States
United States, New York
Amherst, New York, United States
United States, Ohio
Cincinnati, Ohio, United States
Toledo, Ohio, United States
United States, South Carolina
Columbia, South Carolina, United States
United States, Texas
Houston, Texas, United States
United States, Washington
Spokane, Washington, United States
Sponsors and Collaborators
Alza Corporation, DE, USA
Investigators
Study Director: Alza Corporation Clinical Trial ALZA
  More Information

No publications provided

Responsible Party: Alza Corporation, DE, USA
ClinicalTrials.gov Identifier: NCT00424931     History of Changes
Other Study ID Numbers: CR013390, C-2006-028
Study First Received: January 19, 2007
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Alza Corporation, DE, USA:
narcolepsy
sleepiness

Additional relevant MeSH terms:
Narcolepsy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Modafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014