Almorexant (ACT-078573) in Elderly Subjects With Chronic Primary Insomnia

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

ACT-078573 oral capsules at 25 and 100 mg and matching placebo

ACT-078573 and matching placebo

About this trial

This is an interventional treatment trial for Chronic Primary Insomnia focused on measuring insomnia, elderly, sleeplessness

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Elderly subjects (> 64 years) with a diagnosis of primary insomnia.

Exclusion Criteria:

History of any sleep disorder, or any Diagnostic and Statistical Manual of Mental Disorders IV (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.

Sites / Locations

Central Arkansas Research
Pacific Sleep Medicine Services, Inc.
Pacific Sleep Medicine Services, Inc.
California Clinical Trials Medical Group, Inc.
PAB Clinical Research
Miami Research Associates
OmniTrials
Broward Research Group & Sleep-Wake Disorders Center of South Florida
Neurotrials Research, Inc.
Sleep Disorders Center of Georgia
Vince and Associates Clinical Research
Community Research
Clinical Neurophysiology Services, P.C.
Sleep Disorders & Research Center
Clinical Research Center of Nevada
Duke University
Tri-State Sleep Disorders Center
Cleveland Clinic Health Systems
Lynn Health Sciences Institute
Sleep Disorders Center
Sleep Medicine Associates P.A.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Arm Label

ABECD

BCADE

CDBEA

DECAB

EADBC

DCEBA

EDACB

AEBDC

BACED

CBDAE

Arm Description

5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Outcomes

Primary Outcome Measures

Mean Wake Time After Sleep Onset (WASO)

WASO was the time in minutes scored as wake between the onset of persistent sleep and lights on, where the onset of persistent sleep was the beginning of the first continuous 20 epochs (10 min) scored as non-wake. Mean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable due to protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the WASO was missing (e.g., persistent sleep did not occur), the missing value was substituted with the highest value recorded for the subject during the study (single-blind period included).

Secondary Outcome Measures

Mean Total Sleep Time (TST)

TST was the amount of actual sleep time measured in minutes scored as non-wake (i.e., sleep stage 1, 2, slow-wave sleep, or rapid eye movement (sleep)). Mean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable by protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the TST was missing (e.g., the subject did not sleep or persistent sleep did not occur), the missing value was substituted with the worst value recorded for the subject during the study (single-blind period included).

Full Information

NCT ID

NCT00606593

First Posted

January 4, 2008

Last Updated

February 11, 2016

Sponsor

Midnight Pharma, LLC

1. Study Identification

Unique Protocol Identification Number

NCT00606593

Brief Title

Almorexant (ACT-078573) in Elderly Subjects With Chronic Primary Insomnia

Official Title

Multicenter, Double-blind, Randomized, Placebo-controlled, 5-period, 5-treatment Crossover, Dose-finding Study to Evaluate the Efficacy and Safety of Oral Administration of ACT-078573 in Elderly Subjects With Chronic Primary Insomnia

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

December 2007 (undefined)

Primary Completion Date

April 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Midnight Pharma, LLC

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

A 2-night polysomnography / 5-way cross-over study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in elderly subjects with primary insomnia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Primary Insomnia

Keywords

insomnia, elderly, sleeplessness

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

112 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ABECD

Arm Type

Experimental

Arm Description

5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Arm Title

BCADE

Arm Type

Experimental

Arm Description

5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Arm Title

CDBEA

Arm Type

Experimental

Arm Description

5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Arm Title

DECAB

Arm Type

Experimental

Arm Description

5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Arm Title

EADBC

Arm Type

Experimental

Arm Description

5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Arm Title

DCEBA

Arm Type

Experimental

Arm Description

5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Arm Title

EDACB

Arm Type

Experimental

Arm Description

5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Arm Title

AEBDC

Arm Type

Experimental

Arm Description

5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Arm Title

BACED

Arm Type

Experimental

Arm Description

5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Arm Title

CBDAE

Arm Type

Experimental

Arm Description

5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Intervention Type

Drug

Intervention Name(s)

ACT-078573 oral capsules at 25 and 100 mg and matching placebo

Intervention Description

5-period, 5-treatment crossover: sequences: ABECD, BCADE, CDBEA, DECAB, EADBC DCEBA, EDACB, AEBDC, BACED, CBDAE Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Intervention Type

Drug

Intervention Name(s)

ACT-078573 and matching placebo

Intervention Description

ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Intervention Type

Drug

Intervention Name(s)

ACT-078573 and matching placebo

Intervention Description

ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Intervention Type

Drug

Intervention Name(s)

ACT-078573 and matching placebo

Intervention Description

ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Intervention Type

Drug

Intervention Name(s)

ACT-078573 and matching placebo

Intervention Description

ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Intervention Type

Drug

Intervention Name(s)

ACT-078573 and matching placebo

Intervention Description

ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Intervention Type

Drug

Intervention Name(s)

ACT-078573 and matching placebo

Intervention Description

ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Intervention Type

Drug

Intervention Name(s)

ACT-078573 and matching placebo

Intervention Description

ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Intervention Type

Drug

Intervention Name(s)

ACT-078573 and matching placebo

Intervention Description

ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Intervention Type

Drug

Intervention Name(s)

ACT-078573 and matching placebo

Intervention Description

ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Primary Outcome Measure Information:

Title

Mean Wake Time After Sleep Onset (WASO)

Description

WASO was the time in minutes scored as wake between the onset of persistent sleep and lights on, where the onset of persistent sleep was the beginning of the first continuous 20 epochs (10 min) scored as non-wake. Mean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable due to protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the WASO was missing (e.g., persistent sleep did not occur), the missing value was substituted with the highest value recorded for the subject during the study (single-blind period included).

Time Frame

2 treatment nights

Secondary Outcome Measure Information:

Title

Mean Total Sleep Time (TST)

Description

TST was the amount of actual sleep time measured in minutes scored as non-wake (i.e., sleep stage 1, 2, slow-wave sleep, or rapid eye movement (sleep)). Mean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable by protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the TST was missing (e.g., the subject did not sleep or persistent sleep did not occur), the missing value was substituted with the worst value recorded for the subject during the study (single-blind period included).

Time Frame

2 treatment nights

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Elderly subjects (> 64 years) with a diagnosis of primary insomnia. Exclusion Criteria: History of any sleep disorder, or any Diagnostic and Statistical Manual of Mental Disorders IV (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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James K. Walsh, PhD

Organizational Affiliation

Sleep Medicine and Research Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Central Arkansas Research

City

Hot Springs

State/Province

Arkansas

ZIP/Postal Code

71913

Country

United States

Facility Name

Pacific Sleep Medicine Services, Inc.

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Pacific Sleep Medicine Services, Inc.

City

San Diego

State/Province

California

ZIP/Postal Code

92121

Country

United States

Facility Name

California Clinical Trials Medical Group, Inc.

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

PAB Clinical Research

City

Brandon

State/Province

Florida

ZIP/Postal Code

33511

Country

United States

Facility Name

Miami Research Associates

City

Miami

State/Province

Florida

ZIP/Postal Code

33173

Country

United States

Facility Name

OmniTrials

City

Naples

State/Province

Florida

ZIP/Postal Code

34110

Country

United States

Facility Name

Broward Research Group & Sleep-Wake Disorders Center of South Florida

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33026

Country

United States

Facility Name

Neurotrials Research, Inc.

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Sleep Disorders Center of Georgia

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Vince and Associates Clinical Research

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66212

Country

United States

Facility Name

Community Research

City

Crestview Hills

State/Province

Kentucky

ZIP/Postal Code

41017

Country

United States

Facility Name

Clinical Neurophysiology Services, P.C.

City

Troy

State/Province

Michigan

ZIP/Postal Code

48098

Country

United States

Facility Name

Sleep Disorders & Research Center

City

Chesterfield

State/Province

Missouri

ZIP/Postal Code

63017

Country

United States

Facility Name

Clinical Research Center of Nevada

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89104

Country

United States

Facility Name

Duke University

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Tri-State Sleep Disorders Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45227

Country

United States

Facility Name

Cleveland Clinic Health Systems

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Lynn Health Sciences Institute

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Sleep Disorders Center

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29201

Country

United States

Facility Name

Sleep Medicine Associates P.A.

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Chronic Primary Insomnia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial