NarcolepsyPhase 2NCT00424931
A Safety and Effectiveness Study of a Single Dose of JNJ-17216498 in Patients With Narcolepsy
A Phase 2 study testing JNJ-17216498 and Modafinil in people with Narcolepsy, run by Alza Corporation, DE, USA at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Narcolepsy
- What is being tested?
- JNJ-17216498 and Modafinil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 16 sitesUnited States
- Study dates
- Jan 2007to Dec 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosis of narcolepsy within the past 5 years
- good general health
- no history or presence of drug or alcohol abuse
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Study site
Amherst, New York
Study site
Birmingham, Alabama
Study site
Cincinnati, Ohio
Study site
Columbia, South Carolina
Study site
Danville, Indiana
Study site
Fort Wayne, Indiana
Study site
Houston, Texas
Study site
Macon, Georgia
Study site
Phoenix, Arizona
Study site
San Diego, California
Study site
Spokane, Washington
Study site
Spring Hill, Florida
Study site
St. Petersburg, Florida
Study site
Stanford, California
Study site
Toledo, Ohio
Study site
Tucson, Arizona
About this study
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.
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.
Read the 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.
- Conditions
- Narcolepsy
- Being tested
- JNJ-17216498, Modafinil
- Keywords
- narcolepsy, sleepiness
- Medical subject headings
- Narcolepsy, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-17216498Drug
50mg one time
JNJ-17216498Drug
10mg one time
ModafinilDrug
200 mg X 2
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | JNJ-17216498 10mg one time Receives: Drug: JNJ-17216498 |
| 002 | Experimental | JNJ-17216498 50mg one time Receives: Drug: JNJ-17216498 |
| 003 | Active comparator | Modafinil 200 mg X 2 Receives: Drug: Modafinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Explore the effectiveness of JNJ-17216498 in patients with narcolepsy as determined by the Maintenance of Wakefulness Test done throughout the study.
Measured: ·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.
Measured: To explore the safety and tolerability of JNJ-17216498 in patients with narcolepsy with or without cataplexy throughout the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionNov 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alza Corporation, DE, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alza Corporation Clinical Trial, Study director, ALZA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424931
- Sponsor's protocol ID
- CR013390
- Other IDs
- C-2006-028
- Status last verified
- May 2014
- First submitted
- 19 Jan 2007
- Last updated
- 23 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00424931
- Acronym / sponsor ID
- CR013390
- Conditions
- Narcolepsy
- Keywords
- narcolepsy, sleepiness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Alza Corporation, DE, USAIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 22 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: JNJ-17216498JNJ-17216498 10mg one time |
| 002 | Experimental | Drug: JNJ-17216498JNJ-17216498 50mg one time |
| 003 | Active comparator | Drug: ModafinilModafinil 200 mg X 2 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- diagnosis of narcolepsy within the past 5 years
- good general health
- no history or presence of drug or alcohol abuse
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-1721649850mg one time | Drug | 002 |
| JNJ-1721649810mg one time | Drug | 001 |
| Modafinil200 mg X 2 | Drug | 003 |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alza Corporation Clinical Trial study director
ALZA
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JNJ-17216498 and Modafinil in people with Narcolepsy, run by Alza Corporation, DE, USA at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2014.