Sodium Oxybate Oral Solution (Xyrem®) for Narcolepsy

Phase < 1

Waitlist Available

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up data collected on day 1 (baseline visit) of the intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the baseline visit.

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

The study evaluates whether the use of Sodium Oxybate (Xyrem®) in TBI patients will be effective in reducing symptoms of post traumatic narcolepsy and post traumatic hypersomnia.

Eligible Conditions

Excessive daytime sleepiness
Narcolepsy
Traumatic Brain Injury

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ data collected on day 1 (baseline visit) of the intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the baseline visit.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~data collected on day 1 (baseline visit) of the intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the baseline visit.

This trial's timeline: 3 weeks for screening, Varies for treatment, and data collected on day 1 (baseline visit) of the intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the baseline visit. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Clinical Condition

Change in Sleep Duration

Change in Subjective Daytime Sleepiness

+1 more

Secondary study objectives

Change in Global Functioning

Change in Nocturnal Sleep Quality (Change in Pittsburgh Sleep Quality index) scores)

Change in Nocturnal Sleep Quality (Duration of nocturnal awakenings)

+5 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Sodium Oxybate Oral Solution (Xyrem®)Experimental Treatment1 Intervention

4.5g of oral solution Xyrem will be given as a starting dose. This will be titrated up weekly to the final treatment dose of 9.0g. Participants will be on this final dose for 8 weeks.

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