Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia (RESTORA 1)

Midnight Pharma

Status and phase: Completed; Phase 3

Conditions: Primary Insomnia

Treatments: Drug: Placebo; Drug: almorexant; Drug: zolpidem

Study type: Interventional

Funder types: Industry

Identifiers

NCT00608985

AC-057A301

Details and patient eligibility

About

A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.

Enrollment: 709 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult subjects (18-64 years) with a diagnosis of primary insomnia.

Exclusion criteria

• History of any sleep disorder, or any Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) axis I disorder other than primary insomnia.
• Sleep apnea, or restless legs syndrome.
• Daytime napping of more than 1 hour per day.
• Important caffeine consumption, heavy tobacco use, alcohol or drug abuse within 2 years prior to the screening visit.
• Unwillingness to refrain from drugs, over-the-counter or herbal medication having an effect on sleep or behavior.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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709 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

almorexant 200 mg

Treatment:

Drug: almorexant

Drug: almorexant

2

Experimental group

Description:

almorexant 100 mg

Treatment:

Drug: almorexant

Drug: almorexant

3

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

4

Active Comparator group

Description:

zolpidem 10 mg

Treatment:

Drug: zolpidem