A Dose-ranging, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia

Pfizer

Status and phase: Completed; Phase 2

Conditions: Primary Insomnia

Treatments: Other: Placebo; Drug: PD 0200390

Study type: Interventional

Funder types: Industry

Identifiers

NCT00551148

A4251068

Details and patient eligibility

About

The purpose of this study is to further explore an effective dose range of PD0200390 for the treatment of patients with insomnia.

Enrollment: 92 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

3 month history of Primary Insomnia (DSM-IV criteria)

Self report sleep criteria for at least 3 nights per week in past month;

sWASO (subjective wake after sleep onset) equal or greater than 60 mins

sLSO (subjective latency to sleep onset) equal or greater than 45 minutes

TST less than or equal to 6.5 hrs

Maintain normal daytime-awake, nighttime-sleep schedule

PSG sleep criteria of mean WASO equal or greater than 60 mins calculated on 2 PSG screening nights

TST between 3 to 7 hrs on 2 PSG screening nights

Mean LPS (latency to persistent sleep) equal or greater than 20 mins calculated on 2 PSG screening nights

Exclusion criteria

Comorbid psychiatric disease or disorders

History or presence of breathing-related disorders

Multivariable Apnea risk index (MAP) equal or greater than 0.5 at screening

History or presence of medical or neurological condition interfering with sleep

Current use of know psychotropic effect medications

Excessive caffeine use

Use of alcohol as a sleep aid or more than 2 standard drinks/day

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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92 participants in 5 patient groups, including a placebo group

15 mg

Experimental group

Treatment:

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

30 mg

Experimental group

Treatment:

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

5 mg

Experimental group

Treatment:

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

60 mg

Experimental group

Treatment:

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

Placebo

Placebo Comparator group

Treatment:

Other: Placebo