Efficacy and Safety of Volinanserin on Sleep Maintenance Insomnia - Polysomnographic Study (NOCTURNE907)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Sleep Initiation and Maintenance Disorders

Treatments: Drug: volinanserin; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00464243

EUDRACT : 2006-005303-34

EFC6072

Details and patient eligibility

About

The purpose of this study is to assess efficacy and safety of volinanserin 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 non restorative and they suffer from a significant distress or impairment in their daily activities consecutive to insomnia.

Enrollment: 604 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria
• Disturbances of sleep maintenance criteria based on patient's information related to sleep pattern during the preceding month
• Specific criteria based on the NPSG recordings during the screening nights

Exclusion criteria

• Females who are lactating or who are pregnant
• Night shift workers, and individuals who nap 3 or more times per week over the preceding month
• Consumption of xanthine-containing beverages (i.e. tea, coffee, cola) comprising more than 5 cups/day
• Participation in another trial having received study medication within 1 month before the screening visit
• Body Mass Index ≥ 33
• Use of over-the-counter medications such as tryptophan, valerian root, kava, melatonin, St. John's Wort, Alluna or prescription sleep medication
• Use of any substance with psychotropic effects or properties know to affect sleep/wake
• History of primary hypersomnia, narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder, parasomnia, dyssomnia
• Clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder
• Positive qualitative urine drug screen (opiates, cocaine, amphetamine...)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

604 participants in 2 patient groups, including a placebo group

Volinanserin

Experimental group

Description:

2 mg volinanserin tablets orally once daily

Treatment:

Drug: volinanserin

Placebo

Placebo Comparator group

Description:

tablets orally once daily

Treatment:

Drug: placebo