Narcolepsy Clinical Trial Announcement

New Sites Added November 25, 2002 - Additional Sites Available through Orphan Medical

Minneapolis, MN - June 4, 2001

Title

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyrem® (sodium oxybate) with Placebo for the Treatment of Narcolepsy

Purpose of the Study

The purpose of this medical research study is to evaluate the safety and effectiveness of an investigational drug for controlling the symptoms of narcolepsy. Narcolepsy is a chronic neurologic disorder characterized by severe sleepiness, and in most cases, giving way or twitching of muscles when laughing hard, excited, agitated, or surprised. In addition, narcoleptic individuals may sometimes be unable to move their limbs, trunk, neck and face when they awaken and they may experience dream-like images or other hallucinations when they are in the transition between wakefulness and sleep. Participants will be asked to evaluate changes in their symptoms of narcolepsy.

Protocol Summary

The initial portion of the protocol involves discontinuing any medications for cataplexy that the patient may be taking. Subsequently the patient is prescribed a dose of oral solution of study drug or placebo over a 10 - 11 week period. During the trial, your narcolepsy symptoms will be evaluated. Participants are allowed to continue using stimulant medications at constant doses during the study. A total of 1 to 3 daytime visits in addition to 4 overnight visits to the sleep center will be required to complete the study.

Basic Eligibility Criteria

Potential candidates for the trial will have a history of and current symptoms of excessive daytime sleepiness, a history of cataplexy, or a diagnosis of narcolepsy. Patients will not be considered for the trial if they have been diagnosed with severe sleep apnea or restless-leg syndrome, are taking anticonvulsants, have significant or unstable physical or psychiatric condition, or work evenings/nights.

How to Contact a Site for Further Information:

Additional Investigators can be identified by contacting Orphan Medical, Inc. pservices@orphan.com or 1-888-8ORPHAN (1-888-867-7426).

There are additional sites not listed below. Please call or email Orphan for information on those sites.

United States		Canada
California	North Carolina	Alberta
Illinois	Texas	New Brunswick
Massachusetts	Washington

California:
Pacific Sleep Medicine Services
9834 Genesee Ave., Suite #328
La Jolla, CA 92037-1205

Investigator: Milton, Erman, M.D.
Co-Investigator: Roza Hayduk, M.D.
Coordinator: Nanette Matta
Phone: 858-657-0550
Stanford Sleep Disorders Clinic
Suite 3301
401 Quarry Road
Stanford, CA 943305

Investigator: Jed Black, MD
Coordinator: Paul Stowers
Phone: 650-498-6294
E-mail: pstowers@stanford.edu

Illinois
Sleep Disorder Center
Department of Neurology
Evanston Hospital
2650 Ridge Ave.
Evanston, IL 60201
Phone: 847-570-2567

Investigator: Ruzica K. Ristanovic, MD, MS
Coordinator: Cindy Nierodzik, RN
Phone: 847-570-2645
E-mail: r-ristanovic@northwestern.edu

Massachusetts:
Center for Sleep Diagnostics
100 Wells Ave, Suite 101
Newton, Massachusetts 02459

Investigator: Michael P. Biber, M.D.
Coordinator: Chris McCarthy
Phone: 617-796-7766
E-mail: cmccarthy@neurocareinc.com

North Carolina
Duke Neurology Clinical Trials Office
Duke Health Center
932 Morreene Road
Durham, North Carolina 27705

Investigator: Aatif Husain, MD
Coordinator: Kate Beck, RN
Phone: 919-668-2278
E-mail: beck0002@mc.duke.edu

Texas:
Houston Sleep Center Clinic
Institute of Sleep Medicine
8333 Katy Freeway
Houston, Texas, 77024

Investigator: Todd J. Swick, MD
Coordinator: Dawn Fanguy, LVN, CCRC
Phone: 713-465-9282 or 1 86 NIGHTSLP (1 866 444-8757)
Email: dfanguy@houstonsleepcenter.com

Washington
Swedish Sleep Medicine Institute
801 Broadway, Suite 701
Seattle, WA 98122

Investigator: Ralph Pascualy, M.D.
Coordinator: Dallas Parman, RPsgT
Phone: 206-386-3714
E-mail: Dallas.Parman@swedish.org

Canada
Somnology Program
Dept. of Psychiatry
Saint John Regional Hospital
4-D South
400 University Ave.
Saint John, New Brunswick E2L4L2

Investigator: Rachel Morehouse, MD
Coordinator Brenda Lamb, RN
Phone: 506-648-7176

Canadian Sleep Institute
Unit 300
295 Midpark Way SE
Calgary, Alberta T2X2A8
Canada

Investigator: Adam Moscovitch, MD
Coordinator: Ron Chisholm, PhD
Phone: 403-254-6400
E-mail: research@csisleep.com