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• Status: Withdrawn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.