Trial intelligence / Profile preview

Tesamorelin for Sleep Promotion in Service Members with TBI and Insomnia

NCT02931474Phase 2

Key facts

Status: Withdrawn
Start: Oct 2016
Primary completion: Mar 2017
Sponsor: National Institute of Nursing Research
Modality: Peptides

Drugs: tesamorelin
Conditions: Insomnia

Overview

Phase 2, randomised, double-blind trial in Insomnia comparing Tesamorelin Arm with Placebo Arm (2 arms). Primary endpoint: Non-Rapid Eye Movement sleep time. Planned start Oct 2016; status: withdrawn.

Design

2 arms

Study design: RandomizedDouble-blind

Tesamorelin Arm
Participants receive a single dose of tesamorelin during an overnight sleep lab visit.
Placebo Arm
Participants receive a single dose of placebo during an overnight sleep lab visit.

Who it enrols

Active duty service members or veterans (18-45) with a history of TBI (6 months to 10 years ago). Includes one group with clinical insomnia (PSQI > 10) and one group without insomnia (PSQI <= 5). Excludes sleep apnea, major medical/psychiatric illnesses, and recent use of sleep-altering medications.

Endpoints

Primary

Non-Rapid Eye Movement sleep time1-3 weeks

Secondary

Plasma concentration levels of neuroendocrine proteins1-3 weeks
Urinary concentration levels of growth hormone1-3 weeks

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