NCT00424931

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

May 23, 2014

Status Verified

May 1, 2014

Enrollment Period

10 months

First QC Date

January 19, 2007

Last Update Submit

May 21, 2014

Conditions

Narcolepsy

Keywords

narcolepsysleepiness

Outcome Measures

Primary Outcomes (1)

  • Explore the effectiveness of JNJ-17216498 in patients with narcolepsy as determined by the Maintenance of Wakefulness Test done throughout the study.

    ·To explore efficacy of JNJ-17216498 in patients with narcolepsy with or without cataplexy up through 48 hours after dosing.

Secondary Outcomes (1)

  • 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.

    To explore the safety and tolerability of JNJ-17216498 in patients with narcolepsy with or without cataplexy throughout the study.

Study Arms (3)

001

EXPERIMENTAL

JNJ-17216498 10mg one time

Drug: JNJ-17216498

002

EXPERIMENTAL

JNJ-17216498 50mg one time

Drug: JNJ-17216498

003

ACTIVE COMPARATOR

Modafinil 200 mg X 2

Drug: Modafinil

Interventions

JNJ-17216498DRUG

50mg one time

002
ModafinilDRUG

200 mg X 2

003

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

Tucson, Arizona, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Stanford, California, United States

Location

Unknown Facility

Spring Hill, Florida, United States

Location

Unknown Facility

St. Petersburg, Florida, United States

Location

Unknown Facility

Macon, Georgia, United States

Location

Unknown Facility

Danville, Indiana, United States

Location

Unknown Facility

Fort Wayne, Indiana, United States

Location

Unknown Facility

Amherst, New York, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Toledo, Ohio, United States

Location

Unknown Facility

Columbia, South Carolina, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Spokane, Washington, United States

Location

MeSH Terms

Conditions

NarcolepsySleepiness

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Disorders of Excessive SomnolenceSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Alza Corporation Clinical Trial

    ALZA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2007

First Posted

January 22, 2007

Study Start

January 1, 2007

Primary Completion

November 1, 2007

Study Completion

December 1, 2007

Last Updated

May 23, 2014

Record last verified: 2014-05

Locations

US(16)