Completed

Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Armodafinil

+ Armodafinil
+ Placebo
Drug
Who is being recruted

Narcolepsy

From 18 to 65 Years
How is the trial designed

Treatment Study

Placebo-Controlled
Phase 3
Interventional
Study Start: March 2004

Summary

Principal SponsorCephalon
Last updated: July 19, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2004Actual date on which the first participant was enrolled.

The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with narcolepsy by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (20-minute version)(average of 4 naps at 0900, 1100, 1300, and 1500) and by the Clinical Global Impressions of Change (CGI-C) ratings (as related to general condition) at week 12 (or last postbaseline observation)

Official TitleA 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CEP-10953 (150 and 250 mg/Day) as Treatment for Adults With Excessive Sleepiness Associated With Narcolepsy 
Principal SponsorCephalon
Last updated: July 19, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
196 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled
: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 65 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Narcolepsy
Criteria

Diagnosis and Criteria for Inclusion: Patients are included in the study if all of the following criteria are met: * Written informed consent is obtained * The patient is an outpatient, man or woman of any ethnic origin, 18 to 65 years of age (inclusive) * The patient has a complaint of excessive sleepiness * The patient has a current diagnosis of narcolepsy according to ICSD criteria. * The patient is in good health as determined by a medical and psychiatric history, physical examination, electrocardiogram (ECG), and serum chemistry, hematology, and urinalysis. * Women must be surgically sterile, 2 years postmenopausal, or, if of child-bearing potential, using a medically accepted method of birth control (ie, barrier method with spermicide, steroidal contraceptive \[oral, implanted, and Depo-Provera contraceptives must be used in conjunction with a barrier method\], or intrauterine device \[IUD\]) and agree to continued use of this method for the duration of the study. * The patient has a mean sleep latency of 6 minutes or less as determined by the Multiple Sleep Latency Test (MSLT) (performed at 0900, 1100, 1300, and 1500). * The patient has a CGI-S (Clinical Global Impression of Severity of Illness) rating of 4 or more. * The patient does not have any medical or psychiatric disorders that could account for the excessive daytime sleepiness. * The patient is able to complete self rating scales and computer-based testing. * The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol. Criteria for Exclusion: Patients are excluded from participating in this study if 1 or more of the following criteria are met. The patient: * has any clinically significant, uncontrolled medical or psychiatric conditions (treated or untreated) * has a probable diagnosis of a current sleep disorder other than narcolepsy * consumed caffeine including coffee, tea and/or other caffeine containing beverages or food averaging more than 600 mg of caffeine per day * used any prescription drugs disallowed by the protocol or clinically significant use of over the-counter (OTC) drugs within 7 days before the second screening visit * has a history of alcohol, narcotic, or any other drug abuse as defined by the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association, 4th Edition (DSM IV) * has a positive UDS at the screening visit, without medical explanation * has a clinically significant deviation from normal in the physical examination * is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.) * has used an investigational drug within 1 month before the screening visit * has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery) * has a known clinically significant drug sensitivity to stimulants or modafinil


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
3 intervention groups 

are designated in this study

33.333% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Experimental
Armodafinil 250 mg
Group II
Experimental
Armodafinil 150 mg
Group III
Placebo
Placebo
Study Objectives
Primary Objectives

The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient's ability to remain awake. The change from baseline in the mean sleep latency from the MWT (average of 4 tests at 0900, 1100, 1300, and 1500) was analyzed at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MWT sleep latency as assessed at week 12 (or last post-baseline visit).

Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 

CompletedNo study centers