Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia

Withdrawn before enrolling · Early Phase 1

Conditions studied: Hypersomnia, Narcolepsy, Traumatic Brain Injury

In brief

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.

Key facts

Study ID: NCT03626727
Run by: Brigham and Women's Hospital
People needed: 0
Starts: 2020-09-01
Expected to finish: 2020-09-01
Last updated by the study team: 2021-03-04

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

History of first-ever primary TBI 12 or more months ago;
Mild to severe TBI (GCS 3-15);
Either a) or b):
Presence of subjective daytime sleepiness (ESS ≥ 10) lasting 3 months or more, and not present prior to the TBI;
Long sleep duration (mean TST ≥ 9hours/24hrs or increased sleep need of at least 1-2 h per 24 h compared to pre-TBI), documented by actigraphy, lasting 3 months or more;
Objectively demonstrated EDS (MSLT mean of 5 naps: SL ≤ 8min);
Age: 18 - 64;
Ability to read and understand consent form, complete questionnaires and daily sleep diary, and provide informed consent. The Folstein MMSE will be used to assess cognitive function.

You may not qualify if…

Current neurologic deficit (weakness, dysarthria or dysphagia, aphasia or dysphasia); Participants with a score of <27 on Folstein MMSE will be excluded.
History of neurologic or psychiatric disease prior to TBI;
Epilepsy or history of seizure (whether related or unrelated to TBI);
Body mass index (BMI) ≥ 32;
Sleep apnea (Apnea Hypopnea Index, AHI > 15/h); -Chronic sleep restriction (≥ 2hour sleep extension on weekends from self- report, diary, or at least 14 days of actigraphy);
Sleep-wake disturbance other than long sleep duration or sleepiness (DSPD, ASPD, Shift-work Sleep Disorder);
Diagnosis of narcolepsy or other sleep disorder prior to TBI;
Unwillingness to follow physician instructions relating to the concomitant use of alcohol and sodium oxybate during the study;
History of or current substance abuse;
Current regular CNS-affecting medication use;
History of depression, suicidal thoughts, and/or post-traumatic stress disorder (PTSD);
Current depression assessed by a structured clinical interview and Beck Depression Inventory (BDI);
Abnormal liver function (LFT more than twice the upper limit of normal or serum bilirubin more than 1.5 times the upper limit of normal);
Hypertension, heart failure, history of myocardial infarction, or abnormal EKG demonstrating clinically significant arrhythmia;
Kidney disease (Serum creatinine >2.0mg/dl);
Lung disease (COPD, ILD, asthma);
On a low salt diet for medical reasons;
An occupation that requires variable shift work or routine night shifts (work hours between 11pm and 6am);
Pregnant, intention to become pregnant;
Breast-feeding or plans to breastfeed;
Succinic semialdehyde dehydrogenase deficiency.

Where it is running

Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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