Overview

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

Status:
Withdrawn
Trial end date:
2020-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Brigham and Women's Hospital
Treatments:
Pharmaceutical Solutions
Sodium Oxybate
Criteria
Inclusion Criteria:

- History of first-ever primary TBI 12 or more months ago;

- Mild to severe TBI (GCS 3-15);

- Either a) or b):

1. Presence of subjective daytime sleepiness (ESS ≥ 10) lasting 3 months or more,
and not present prior to the TBI;

2. 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.

Exclusion Criteria:

- 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.