NCT00606593

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 4, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

March 11, 2013

Completed
Last Updated

March 14, 2016

Status Verified

February 1, 2016

Enrollment Period

4 months

First QC Date

January 4, 2008

Results QC Date

December 21, 2012

Last Update Submit

February 11, 2016

Conditions

Chronic Primary Insomnia

Keywords

insomniaelderlysleeplessness

Outcome Measures

Primary Outcomes (1)

  • 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).

    2 treatment nights

Secondary Outcomes (1)

  • Mean Total Sleep Time (TST)

    2 treatment nights

Study Arms (10)

ABECD

EXPERIMENTAL

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

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

BCADE

EXPERIMENTAL

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

Drug: ACT-078573 and matching placebo

CDBEA

EXPERIMENTAL

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

Drug: ACT-078573 and matching placebo

DECAB

EXPERIMENTAL

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

Drug: ACT-078573 and matching placebo

EADBC

EXPERIMENTAL

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

Drug: ACT-078573 and matching placebo

DCEBA

EXPERIMENTAL

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

Drug: ACT-078573 and matching placebo

EDACB

EXPERIMENTAL

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

Drug: ACT-078573 and matching placebo

AEBDC

EXPERIMENTAL

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

Drug: ACT-078573 and matching placebo

BACED

EXPERIMENTAL

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

Drug: ACT-078573 and matching placebo

CBDAE

EXPERIMENTAL

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

Drug: ACT-078573 and matching placebo

Interventions

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

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

ABECD
ACT-078573 and matching placeboDRUG

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

BCADE

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Central Arkansas Research

Hot Springs, Arkansas, 71913, United States

Location

Pacific Sleep Medicine Services, Inc.

Los Angeles, California, 90048, United States

Location

Pacific Sleep Medicine Services, Inc.

San Diego, California, 92121, United States

Location

California Clinical Trials Medical Group, Inc.

San Diego, California, 92123, United States

Location

PAB Clinical Research

Brandon, Florida, 33511, United States

Location

Miami Research Associates

Miami, Florida, 33173, United States

Location

OmniTrials

Naples, Florida, 34110, United States

Location

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

Pembroke Pines, Florida, 33026, United States

Location

Neurotrials Research, Inc.

Atlanta, Georgia, 30342, United States

Location

Sleep Disorders Center of Georgia

Atlanta, Georgia, 30342, United States

Location

Vince and Associates Clinical Research

Overland Park, Kansas, 66212, United States

Location

Community Research

Crestview Hills, Kentucky, 41017, United States

Location

Clinical Neurophysiology Services, P.C.

Troy, Michigan, 48098, United States

Location

Sleep Disorders & Research Center

Chesterfield, Missouri, 63017, United States

Location

Clinical Research Center of Nevada

Las Vegas, Nevada, 89104, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Tri-State Sleep Disorders Center

Cincinnati, Ohio, 45227, United States

Location

Cleveland Clinic Health Systems

Cleveland, Ohio, 44195, United States

Location

Lynn Health Sciences Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Sleep Disorders Center

Columbia, South Carolina, 29201, United States

Location

Sleep Medicine Associates P.A.

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

almorexant

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Results Point of Contact

Title
Pascal Charef/Clinical Trial Leader
Organization
Actelion Pharmaceuticals Ltd
+41 61 565 65 65

Study Officials

  • James K. Walsh, PhD

    Sleep Medicine and Research Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2008

First Posted

February 4, 2008

Study Start

December 1, 2007

Primary Completion

April 1, 2008

Study Completion

May 1, 2008

Last Updated

March 14, 2016

Results First Posted

March 11, 2013

Record last verified: 2016-02

Locations

US(21)