Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia (GEMS)

Sanofi

Status and phase

Completed

Phase 3

Conditions

Sleep Initiation and Maintenance Disorders

Insomnia

Treatments

Drug: placebo

Drug: Eplivanserin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00253968

LTE6217

2005-003080-23 (EudraCT Number)

Details and patient eligibility

About

The purpose of the study is to assess efficacy and safety of eplivanserin in the population of patients complaining of sleep maintenance insomnia. The patients suffering from that condition frequently wake up during the night, their sleep is nonrestorative and they suffer from a significant distress or impairment in their daily activities consecutive to insomnia.

Full description

12 weeks for each patient (double-blind period) + 1 week of run-in (placebo), and 2 weeks of run-out (placebo)

Total Duration of observation: 15 weeks for each patient

Enrollment

967 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Out patients
Each patient must have primary insomnia in accordance with DSM-IV-TR-Axis I (Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition-Text Revision) criteria
Based on patient's information, the patient must complain of at least one hour of wakefulness after sleep onset for at least 3 nights per week over the preceding month
Patient must report impact daytime functioning associated with sleep maintenance insomnia as measured by question 3 of Insomnia Severity Index at screening visit and randomization visit.

Exclusion criteria

Females who are lactating or pregnant
Woman of childbearing potential with a positive serum beta human chorionic gonadotropin pregnancy test at screening and not using an acceptable form of contraception
Patients presenting with acute or chronic pain resulting in insomnia
Patients with history of epilepsy or seizures
Consumption of xanthine containing beverage (i.e. tea, coffee, or cola) comprising more than 5 glasses/day
Evidence of any clinically significant, severe, or unstable acute or chronically progressive medical or surgical disorder which may affect patient safety
BMI >32
Acute or chronic pain resulting in insomnia
Patients with current psychiatric disorders according to DSM-IV-TR criteria, mental retardation, or dementia
Clinically significant and abnormal EKG (QTc interval >=500 msec)
Positive for hepatitis B or C
Serious head injury or stroke within 1 year
Use of OTC (over-the-counter) medications such as valerian root, kava, melatonin, St. John's Wort, or alluna; prescription sleep medications or anxiolytics within 1 week or 5 half-lives
Participation in another trial within two month before the screening visit
Use of any substance with psychotropic effects or properties known to affect sleep/wake
Unable to complete the study questionnaires
Night shift workers, and individuals who nap 3 or more times per week over the preceding month
History of:
- Primary hypersomnia
- Narcolepsy
- Breathing-related sleep disorder (such as sleep apnea)
- Circadian rhythm sleep disorder
- Parasomnia (somnambulism)
- Dyssomnia (such as periodic leg movements)