Clinical Trials for Narcolepsy

Clinical trials are research studies conducted in an effort to improve overall patient health and care. Each trial involves running supervised tests to determine the effectiveness and safety of new drugs, procedures and/or devices with the aim of answering scientific questions about a disease or condition. Risks and side-effects are also evaluated during these trials with results ranging from being unpleasant, with side effects such as headaches, to more serious or even life-threatening risks. A clinical trial may be separated into phases, or steps, with each step designed to answer a separate research question. This maybe reflected in the trial name.

A brief description of each phase:

• Phase I: Usually designed to evaluate safety, determine a safe dosage range, and identify side effects on a small group of patients.
• Phase II: If Phase I is successful, the trial is then repeated with a larger group to further evaluate its effect and safety.
• Phase III: Trials are conducted on an ever larger group and are compared with the best current treatment while gathering more information on effect and safety.
• Phase IV: These studies monitor long-term side effects after the treatment has been marketed.

Clinical Trials data for Narcolepsy is grouped into the following categories:-

• View by trial name
• View by drugs used in Narcolepsy clinical trials

Clinical Trials by trial name

The format for each of the following is:

• The name of the trial,
• followed by whether the trial is recruiting patients,
  - The trial may not have started and not yet recruiting, or the trial may have started and do not need any more recruitements, or the trial may be completed.
  - Note**: Please follow the link to determine the current trial status.
• followed by a list of drug/s, if any, used in the trial

ClinicalTrials.gov has listed the following trials for Narcolepsy:

• Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy - This study has been completed (Current: 23 Nov 2006) - sodium oxybate
• Safety and Efficacy Study of CEP-10953 in the Treatment of Excessive Sleepiness Associated With Narcolepsy - This study has been completed (Current: 23 Nov 2006) - CEP-10953
• PROVIGIL (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome - This study is no longer recruiting patients (Current: 23 Nov 2006) - Modafinil
• Sleep Disorders of Patients With Diseases of the Nervous System - This study is currently recruiting patients (Current: 23 Nov 2006)
• Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients - This study has been completed (Current: 23 Nov 2006) - sodium oxybate
• CEP-10953 for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder - This study is no longer recruiting patients (Current: 23 Nov 2006) - CEP-10953
• Trial of Xyrem (Sodium Oxybate) for the Treatment of Narcolepsy - This study is currently recruiting patients (Current: 23 Nov 2006) - Xyrem (sodium oxybate) oral solution
• Observational Study to Evaluate Risks of Side Effects, Drug Abuse and Dependence in Patients Who Received Xyrem on Prescription - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• Body Weight Regulation in Patients With Narcolepsy - This study is currently recruiting patients (Current: 23 Nov 2006)
• Effectiveness Of The Drug GSK189254 In Treating Patients With Narcolepsy - This study is currently recruiting patients (Current: 23 Nov 2006) - GSK189254
• Study of PROVIGIL (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy - This study has been completed (Current: 23 Nov 2006) - Modafinil
• Provigil (Modafinil) Study by Taiwan Biotech Co. - This study has been completed (Current: 23 Nov 2006) - Modafinil
• Assess the Safety and Effectiveness of PROVIGIL Treatment in Children and Adolescents With Excessive Sleepiness - This study has been completed (Current: 23 Nov 2006) - PROVIGIL (modafinil)
• Extension Study of the Safety and Efficacy of CEP-10953 in the Treatment of Patients With Excessive Sleepiness - This study is no longer recruiting patients (Current: 23 Nov 2006) - CEP-10953
• Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome - This study is no longer recruiting patients (Current: 23 Nov 2006) - Armodafinil
• Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes - This study is currently recruiting patients (Current: 23 Nov 2006) - Sodium Oxybate (Xyrem)

Drugs used in Clinical Trials for Narcolepsy

The format for each of the following is:

• The drug,
• followed by the name of the trial,
• followed by whether the trial is recruiting patients,
  - The trial may not have started and not yet recruiting, or the trial may have started and do not need any more recruitements, or the trial may be completed.
  - Note**: Please follow the link to determine the current trial status.

ClinicalTrials.gov has listed the following drugs in trials for Narcolepsy:

• Armodafinil - Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome - This study is no longer recruiting patients (Current: 23 Nov 2006)
• CEP-10953 - CEP-10953 for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder - This study is no longer recruiting patients (Current: 23 Nov 2006)
• CEP-10953 - Extension Study of the Safety and Efficacy of CEP-10953 in the Treatment of Patients With Excessive Sleepiness - This study is no longer recruiting patients (Current: 23 Nov 2006)
• CEP-10953 - Safety and Efficacy Study of CEP-10953 in the Treatment of Excessive Sleepiness Associated With Narcolepsy - This study has been completed (Current: 23 Nov 2006)
• GSK189254 - Effectiveness Of The Drug GSK189254 In Treating Patients With Narcolepsy - This study is currently recruiting patients (Current: 23 Nov 2006)
• Modafinil - PROVIGIL (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Modafinil - Provigil (Modafinil) Study by Taiwan Biotech Co. - This study has been completed (Current: 23 Nov 2006)
• Modafinil - Study of PROVIGIL (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy - This study has been completed (Current: 23 Nov 2006)
• PROVIGIL (modafinil) - Assess the Safety and Effectiveness of PROVIGIL Treatment in Children and Adolescents With Excessive Sleepiness - This study has been completed (Current: 23 Nov 2006)
• Sodium Oxybate (Xyrem) - Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes - This study is currently recruiting patients (Current: 23 Nov 2006)
• Sodium Oxybate - Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients - This study has been completed (Current: 23 Nov 2006)
• Sodium Oxybate - Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy - This study has been completed (Current: 23 Nov 2006)
• Xyrem (sodium oxybate) oral solution - Trial of Xyrem (Sodium Oxybate) for the Treatment of Narcolepsy - This study is currently recruiting patients (Current: 23 Nov 2006)

The trial data on this page has been sourced from

• The U.S. National Library of Medicine (NLM) together with ClinicalTrials.gov