Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00107796
Other study ID # C1538/3027/NA/MN-Narcolepsy
Secondary ID
Status Completed
Phase Phase 3
First received April 8, 2005
Last updated August 22, 2012
Start date October 2004
Est. completion date September 2005

Study information

Verified date May 2006
Source Teva Pharmaceutical Industries
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health Canada
Study type Interventional

Clinical Trial Summary

Primary Objectives: The primary objectives of the study are to determine the effectiveness of PROVIGIL treatment, compared to placebo treatment, in children and adolescents with excessive sleepiness (ES) associated with narcolepsy, as assessed by:

- mean sleep latency from the Multiple Sleep Latency Test (MSLT) (average of 4 naps performed at 0900, 1100, 1300, and 1500) at the last post-baseline observation (week 6 or early termination)

- the Clinical Global Impression of Change (CGI-C) ratings for ES, at the last post-baseline observation (week 6 or early termination).


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date September 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Years to 16 Years
Eligibility Inclusion Criteria:

Diagnosis and Main Criteria for Inclusion (Patients are included in the study if all of the following criteria are met):

- Written informed consent/assent is obtained

- A boy or girl aged 6 through 16 years, inclusive

- Meet the minimal criteria established by the International Classification of Sleep Disorders (ICSD) manual of the American Academy of Sleep Medicine (AASM) for narcolepsy (or presumed narcolepsy) as assessed by all of the following: *clinical history;

- NPSG (nocturnal polysomnogram) (as evaluated by the investigator) to rule out other sleep disorders (ie, obstructive sleep apnea/hypopnea syndrome [OSAHS] or periodic limb movement with sleep [PLMs]);

- narcolepsy (or presumed narcolepsy) as identified by at least 1 of the following: MSLT (as evaluated by the investigator) (mean sleep latency [from 4 naps] <10 minutes); 2 sleep onset REM periods (SOREMP); cataplexy; sleep paralysis; hypnogogic hallucinations -OR- *have a previous diagnosis of narcolepsy on the basis of NPSG and/or MSLT at any time before the screening visit

- Have ES (MSLT <10 minutes and/or CGI S =4) that is not a direct result of inadequate sleep hygiene or other medical disorder

- Are in good health as determined by a medical and psychiatric history, physical examination, ECG, and clinical laboratory tests

- Have blood pressure values greater than those for the 5th percentile and less than the 95th percentile for age on the National High Blood Pressure Education Program guidelines for blood pressure levels for boys and girls ages 6 through 16 years

- Girls who are post menarche or sexually active must have a negative urine pregnancy test prior to the baseline visit, must be using a medically acceptable method of birth control, and must agree to continue use of this method for the duration of the study (and for 30 days after participation in the study). Acceptable methods of birth control include: barrier method with spermicide; steroidal contraceptive (eg, oral, transdermal, implanted, or injected) in conjunction with a barrier method; intrauterine device (IUD); or abstinence.

- Be able to swallow a placebo tablet the same size and shape as the study drug tablet

- Negative UDS (urine drug screen) for any illicit drug, alcohol (ethanol), stimulants, or modafinil at screening; if positive for stimulants or modafinil (prescribed for ES) at the screening visit, UDS to be repeated after a washout period and before the baseline visit

- Have a parent or legal guardian who is willing to participate in the study

Exclusion Criteria:

Main Criteria for Exclusion (Patients are excluded from participating in this study if 1 or more of the following criteria are met):

- Have any other disorder(s) that could be considered the primary cause of ES (eg, self induced sleep deprivation)

- Have a past or present seizure disorder (except history of a single febrile seizure), a history of psychosis, or of clinically significant head trauma (eg, brain damage) or past neurosurgery

- Have a history of suicide attempt, or are at suicidal risk

- Have an average of 5 or more apneic/hypopneic episodes per hour of nocturnal sleep as assessed by NPSG at the baseline visit

- A clinically significant drug sensitivity to stimulants such as amphetamine, dextroamphetamine, methylphenidate, or pemoline; and/or modafinil or any of its components

- Use of any prescription (eg, clonidine, guanfacine) or nonprescription (over the counter [OTC]) medications, including dietary supplements with psychoactive properties (eg, any OTC medications or supplements containing ephedrine [ie, ma huang or ephedra], pseudoephedrine, caffeine, or phenylpropanolamine) or sedating properties (ie, antihistamines or sedative hypnotics) within 1 week of the baseline visit (Note: Medications for the treatment of cataplexy will be permitted if the patient has been on a stable dose for at least 1 month.)

- Use of any MAO (monoamine oxidase) inhibitors or SSRIs (Selective Serotonin Reuptake Inhibitors) within 2 weeks of the baseline visit (unless used for cataplexy)

- Received any investigational drug (except modafinil) within 4 weeks of the baseline visit

- Any disorder that could interfere with drug absorption, distribution, metabolism, or excretion (including previous gastrointestinal surgery)

- Active, clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematologic, neoplastic, endocrine, neurologic, immunodeficiency, pulmonary, or other major clinically significant disorder/disease

- Any clinically significant deviation from the normal range(s) in the physical examination or ECG findings, or clinical laboratory test results (ie, serum chemistry, hematology, and urinalysis) at the screening or baseline visit

- ANC (absolute neutrophil count) below the lower limit of normal at the screening visit (Note: If the ANC is below the lower limit of normal at the baseline visit, the medical monitor will be consulted for continued eligibility in the study.)

- Seated pulse outside the range of 60 through 115 bpm after resting for 5 minutes

- A history of alcohol, narcotic, or any other substance abuse or dependence as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, 4th Edition (DSM IV) criteria

- A total daily intake of more than 250 mg of caffeine per day (eg, approximately five 12 ounce caffeinated sodas, 2.5 cups of coffee or tea, or about 12.5 ounces of chocolate per day) within 1 week of the baseline visit

- Pregnant or lactating/nursing girl; any girl who becomes pregnant during the study will be withdrawn

- A clinically significant illness within 4 weeks of the baseline visit; or is symptomatic for any clinically significant illness at the screening or baseline visit

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Modafinil


Locations

Country Name City State
Canada Adam Moscovitch, M.D. Calgary Alberta
Canada Leonid Kayumov, M.D. Scarborough Ontario
Canada Colin Shapiro, Ph.D. Toronto Ontario
Canada Mortimer Mamelak, M.D. Toronto Ontario
Canada Allen Denys, M.D. Windsor Ontario
United States William Pistone, M.D. Allentown Pennsylvania
United States Daniela Minecan, M.D. Ann Arbor Michigan
United States D. Alan Lankford, Ph.D. Atlanta Georgia
United States Gary Montgomery, M.D. Atlanta Georgia
United States Jerry Silverboard, M.D. Atlanta Georgia
United States John Hudson, M.D. Austin Texas
United States Jeffery Gould, M.D. Bethlehem Pennsylvania
United States Chris M. Makris, M.D. Birmingham Alabama
United States Robert Doekel, Jr., M.D. Birmingham Alabama
United States James Lee, M.D. Charlotte North Carolina
United States Helene A. Emsellem, M.D. Chevy Chase Maryland
United States Michael Kohrman, M.D. Chicago Illinois
United States Stephen H. Sheldon, D.O., FAAP Chicago Illinois
United States Bruce Corser, M.D. Cincinnati Ohio
United States Martin Scharf, Ph.D. Cincinnati Ohio
United States Raouf Amin, MD Cincinnati Ohio
United States Guillermo Borrero, M.D. Clairton Pennsylvania
United States Carol Rosen, M.D. Cleveland Ohio
United States Pradeep Sahota, M.D. Columbia Missouri
United States Richard Bogan, M.D., FCCP Columbia South Carolina
United States David Sperry, M.D. Dallas Texas
United States James Cook, M.D. Danville Indiana
United States Markus H. Schmidt, M.D., Ph.D. Dublin Ohio
United States Dainis Irbe, M.D. Eugene Oregon
United States George Zureikat, M.D. Flint Michigan
United States Joseph McCarty, M.D. Fort Smith Arkansas
United States Marc Raphaelson, M.D. Frederick Maryland
United States John Harsh, Ph.D., DABSM Hattiesburg Mississippi
United States Todd J. Swick, M.D. Houston Texas
United States Julie Thompson-Dobkin, D.O. Huntington Beach California
United States John L. Carroll, M.D. Little Rock Arkansas
United States Samuel Boellner, M.D. Little Rock Arkansas
United States Mark Buchfuhrer, M.D. Long Beach California
United States Yury Furman, M.D. Los Angeles California
United States Karen Waters, M.D. Louisville Kentucky
United States Charles Wells, Jr., M.D. Macon Georgia
United States Anna Ivanenko, M.D., Ph.D. Maywood Illinois
United States Amerigo Padilla, M.D. Miami Florida
United States Julie Jacques, D.O. Morristown Tennessee
United States Kathleen Ryan, M.D. Mount Laurel New Jersey
United States Martin A. Cohn, M.D. Naples Florida
United States Sushmita Mikkilineni, M.D. New Brunswick New Jersey
United States Gary Zammit, M.D. New York New York
United States Monroe Karetzky, M.D. Newark New Jersey
United States Henry Lahmeyer, M.D. Northfield Illinois
United States Jorg Pahl, M.D. Oklahoma City Oklahoma
United States William C. Orr, Ph.D. Oklahoma City Oklahoma
United States Stuart Menn, M.D. Palm Springs California
United States Richard Shubin, M.D. Pasadena California
United States Lee Brooks, M.D. Philadelphia Pennsylvania
United States Barbara Harris, Ph.D. Phoenix Arizona
United States Lee Brooks, M.D. Princeton New Jersey
United States Judith Owens, M.D., MPH Providence Rhode Island
United States William Torch, M.D., MS Reno Nevada
United States Lawrence Sher, M.D. Rolling Hills Estates California
United States James M. Ferguson, M.D. Salt Lake City Utah
United States Jerry J. Tomasovic, M.D. San Antonio Texas
United States Milton K. Erman, M.D. San Diego California
United States Stephen Brooks, M.D. San Francisco California
United States Paul Haberman, M.D. Santa Monica California
United States Ralph A. Pascualy, M.D. Seattle Washington
United States Margaret Ann Springer, M.D. Shreveport Louisiana
United States Jed Black, M.D. Stanford California
United States Michael Neeb, Ph.D. Toledo Ohio
United States William Leeds, D.O. Topeka Kansas
United States Marc Seelagy, M.D. Trenton New Jersey
United States Derek Loewy, Ph.D. Tucson Arizona
United States Stuart Quan, M.D. Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
Cephalon

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean sleep latency from the Multiple Sleep Latency Test (MSLT) (average of 4 naps performed at 0900, 1100, 1300, and 1500) at the last post baseline observation (week 6 or early termination)
Primary The Clinical Global Impression of Change (CGI-C) ratings for ES, at the last post baseline observation (week 6 or early termination)
Secondary Clinical Global Impression of Change (CGI-C) ratings for ES at weeks 3 and 6
Secondary Total score from the Pediatric Daytime Sleepiness Scale (PDSS) at weeks 3 and 6, and last postbaseline observation
Secondary Mean sleep latency from the MSLT (average of 4 naps performed at 0900, 1100, 1300, and 1500) at week 6
See also
  Status Clinical Trial Phase
Completed NCT04072380 - A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy Phase 2
Withdrawn NCT03626727 - Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia Early Phase 1
Completed NCT02821715 - Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients Phase 2
Completed NCT01789398 - Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV) Phase 3
Completed NCT01681121 - A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy Phase 2
Completed NCT00174174 - Provigil (Modafinil) Study by Taiwan Biotech Co. N/A
Completed NCT05059223 - A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy Phase 3
Completed NCT04923594 - Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy Phase 2
Recruiting NCT06279247 - Proteomics and Metabolomics of Body Fluid in Patients With Narcolepsy
Completed NCT04647903 - Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (ADAIR) Phase 1
Completed NCT03267303 - A Study to Evaluate the Safety and Efficacy of TS-091 in Patients With Narcolepsy Phase 2
Completed NCT03173378 - Evaluation of Academic and Professional Trajectories of Narcoleptic Patients
Completed NCT05055024 - An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy Phase 2
Completed NCT01067235 - Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy Phase 3
Completed NCT00228566 - Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome Phase 3
Completed NCT00107848 - PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome Phase 3
Completed NCT00132873 - Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy Phase 3
Enrolling by invitation NCT05113745 - A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy Phase 3
Suspended NCT04419792 - 'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'
Recruiting NCT04899947 - Child and Adolescent Registry for Participants With Narcolepsy