VEC-162 Study in Adult Patients With Primary Insomnia

Vanda Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Primary Insomnia

Treatments: Drug: VEC-162 50 mg; Drug: Placebo; Drug: VEC-162 20 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00548340

VP-VEC-162-3104

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of a 5 week double-blind treatment period of VEC-162 as compared to placebo in male and female patients with primary insomnia.

Enrollment: 322 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females with a diagnosis of primary insomnia as defined in DSM-IV.
• Habitual bedtime between 9:00 pm and 1:00 am.
• No history or evidence of restless leg syndrome or periodic limb movement disorder or sleep apnea.
• Patients must sign a written consent form.

Exclusion criteria

• History of drug or alcohol abuse as defined in DSM-IV.
• History of psychiatric disorders, including Major Depressive Disorder, Generalized Anxiety Disorder and delirium.
• History of chronic obstructive pulmonary disease (COPD), seizures, sleep apnea, narcolepsy, circadian-rhythm sleep disorder, parasomnia or any sleep disorder other than chronic insomnia.
• Recent history of shift work or jet lag.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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322 participants in 3 patient groups, including a placebo group

VEC-162 20 mg

Experimental group

Description:

VEC-162 (tasimelteon) 20 mg capsules PO daily for five weeks

Treatment:

Drug: VEC-162 20 mg

VEC-162 50 mg

Experimental group

Description:

VEC-162 (tasimelteon) 50 mg capsules PO daily for five weeks

Treatment:

Drug: VEC-162 50 mg

Placebo

Placebo Comparator group

Description:

Placebo capsules PO daily five weeks

Treatment:

Drug: Placebo