Chronic Primary InsomniaPhase 2NCT00606593

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

A Phase 2 study of Chronic Primary Insomnia, run by Midnight Pharma, LLC at 21 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Chronic Primary Insomnia
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 112 participants
Where: 21 sitesUnited States
Study dates: Dec 2007to May 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

United States21 sites

Neurotrials Research, Inc.
Atlanta, Georgia, 30342
Sleep Disorders Center of Georgia
Atlanta, Georgia, 30342
PAB Clinical Research
Brandon, Florida, 33511
Sleep Disorders & Research Center
Chesterfield, Missouri, 63017
Tri-State Sleep Disorders Center
Cincinnati, Ohio, 45227
Cleveland Clinic Health Systems
Cleveland, Ohio, 44195
Sleep Disorders Center
Columbia, South Carolina, 29201
Community Research
Crestview Hills, Kentucky, 41017
Sleep Medicine Associates P.A.
Dallas, Texas, 75231
Duke University
Durham, North Carolina, 27710
Central Arkansas Research
Hot Springs, Arkansas, 71913
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104
Pacific Sleep Medicine Services, Inc.
Los Angeles, California, 90048
Miami Research Associates
Miami, Florida, 33173
OmniTrials
Naples, Florida, 34110
Lynn Health Sciences Institute
Oklahoma City, Oklahoma, 73112
Vince and Associates Clinical Research
Overland Park, Kansas, 66212
Broward Research Group & Sleep-Wake Disorders Center of South Florida
Pembroke Pines, Florida, 33026
Pacific Sleep Medicine Services, Inc.
San Diego, California, 92121
California Clinical Trials Medical Group, Inc.
San Diego, California, 92123
Clinical Neurophysiology Services, P.C.
Troy, Michigan, 48098

Other trials in United States

About this study

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

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.

Conditions: Chronic Primary Insomnia
Being tested: ACT-078573 oral capsules at 25 and 100 mg and matching placebo, ACT-078573 and matching placebo
Keywords: insomnia, elderly, sleeplessness
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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
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
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
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
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
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
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
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
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
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

Study groups in NCT00606593
Study group	Role	What they receive
ABECD	Experimental	5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: ACT-078573 and matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 2 treatment nights

Secondary outcomes (1)

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).
Measured: 2 treatment nights

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2007May 2008

First posted4 Feb 2008 (estimated)
Study startDec 2007
Primary completionApr 2008
Study completionMay 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Primary InsomniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 112 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00606593
Sponsor's protocol ID: AC-057A201
Status last verified: Feb 2016
First submitted: 4 Jan 2008
Last updated: 14 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Primary Insomnia trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00606593
Acronym / sponsor ID: AC-057A201
Conditions: Chronic Primary Insomnia
Keywords: insomnia, elderly, sleeplessness
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 112 participants (actual)
Lead sponsor: Midnight Pharma, LLCIndustry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: Apr 2008 (actual)
Study completion: May 2008 (actual)
First posted: 4 Feb 2008 (estimated)
Results: Posted 11 Mar 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 10

Arm	Type	Receives
ABECD	Experimental	Drug: ACT-078573 oral capsules at 25 and 100 mg and matching placebo5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
BCADE	Experimental	Drug: ACT-078573 and matching placebo5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
CDBEA	Experimental	Drug: ACT-078573 and matching placebo5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
DECAB	Experimental	Drug: ACT-078573 and matching placebo5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
EADBC	Experimental	Drug: ACT-078573 and matching placebo5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
DCEBA	Experimental	Drug: ACT-078573 and matching placebo5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
EDACB	Experimental	Drug: ACT-078573 and matching placebo5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
AEBDC	Experimental	Drug: ACT-078573 and matching placebo5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
BACED	Experimental	Drug: ACT-078573 and matching placebo5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
CBDAE	Experimental	Drug: ACT-078573 and matching placebo5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ACT-078573 oral capsules at 25 and 100 mg and matching placebo5-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	Drug	ABECD
ACT-078573 and matching placeboACT-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	Drug	BCADE
ACT-078573 and matching placeboACT-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	Drug	CDBEA
ACT-078573 and matching placeboACT-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	Drug	DECAB
ACT-078573 and matching placeboACT-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	Drug	EADBC
ACT-078573 and matching placeboACT-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	Drug	DCEBA
ACT-078573 and matching placeboACT-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	Drug	EDACB
ACT-078573 and matching placeboACT-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	Drug	AEBDC
ACT-078573 and matching placeboACT-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	Drug	CBDAE
ACT-078573 and matching placeboACT-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	Drug	BACED

Primary outcome

Mean Wake Time After Sleep Onset (WASO)
Time frame: 2 treatment nights
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).

1 secondary outcome

Mean Total Sleep Time (TST)
Time frame: 2 treatment nights

Results and safety

Results posted to the registry on 11 Mar 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence 200/100/P/50/25	11	10
Treatment Sequence 100/50/200/25/P	11	11
Treatment Sequence 50/25/100/P/200	11	9
Treatment Sequence 25/P/50/200/100	11	10
Treatment Sequence P/200/25/100/50	12	11
Treatment Sequence 25/50/P/100/200	11	11
Treatment Sequence P/25/200/50/100	11	10
Treatment Sequence 200/P/100/25/50	11	9
Treatment Sequence 100/200/50/P/25	12	11
Treatment Sequence 50/100/25/200/P	11	11

Primary outcome: Mean Wake Time After Sleep Onset (WASO)

Time frame: 2 treatment nights. Mean (Standard Deviation). Unit: minutes

Measure	Placebo n = 100	ACT-078573 25 mg n = 100	ACT-078573 50 mg n = 100	ACT-078573 100 mg n = 100	ACT-078573 200 mg n = 100
Value	109.1 (36.0)	98.7 (35.5)	90.0 (35.7)	77.7 (33.2)	62.6 (27.5)

Placebo vs ACT-078573 25 mg: Least square means treatment effect: -10.4 (95% CI -17.0 to -3.9), p = 0.0018, Linear model
Placebo vs ACT-078573 50 mg: Least square means treatment effect: -19.2 (95% CI -25.7 to -12.6), p <0.0001, Linear model
Placebo vs ACT-078573 100 mg: Least square means treatment effect: -31.4 (95% CI -38.0 to -24.9), p <0.0001, Linear model

Population analysed: Number of evaluable patients for this parameter in the per protocol set. Only subjects with all 5 valid values are included in this analysis.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single-blind Placebo	0 of 112 (0%)	5 of 112 (4.5%)	Not reported
Placebo	1 of 107 (0.9%)	12 of 107 (11.2%)	Not reported
ACT-078573 25 mg	0 of 106 (0%)	12 of 106 (11.3%)	Not reported
ACT-078573 50 mg	0 of 106 (0%)	10 of 106 (9.4%)	Not reported
ACT-078573 100 mg	0 of 106 (0%)	11 of 106 (10.4%)	Not reported
ACT-078573 200 mg	0 of 108 (0%)	10 of 108 (9.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James K. Walsh, PhD principal investigator

Sleep Medicine and Research Center

21 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study of Chronic Primary Insomnia, run by Midnight Pharma, LLC at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Wake Time After Sleep Onset (WASO) (time frame: 2 treatment nights). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00606593.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2016.