InsomniaPhase 3NCT01021813

A Long Term Safety Study of Suvorexant in Participants With Primary Insomnia (MK-4305-009 AM3)

A Phase 3 study testing Suvorexant in people with Insomnia, run by Merck Sharp & Dohme LLC.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Insomnia
What is being tested?: Suvorexant
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 781 participants
Where: No sites listed yet
Study dates: 10 Dec 2009to 1 Aug 2011
Phase: Phase 3
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of primary insomnia
Participant is able to read, understand, and complete questionnaires and diaries
If female, participant and partner both agree to use acceptable contraception. If male partner does not use an effective form of contraception, female participant must use 2 acceptable forms of contraception
If ≥65 years of age, score of ≥25 on the Mini Mental State Examination (MMSE)

Who cannot join

If female, participant is pregnant
Participant expects to donate eggs or sperm during the study
Recent and/or active history of a confounding neurological disorder
History of clinically unstable cardiovascular disorder within the last 6 months
Lifetime history of bipolar disorder
Psychiatric condition that requires treatment with a medication prohibited by the study, or any other psychiatric condition that would interfere with the participant's ability to participate in the study

Show all 12Show fewer

History of substance abuse/dependence
History of cancer ≤5 years prior to study participation except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
Evidence of suicidality (based on a score of 2 on the Quick Inventory of Depressive Symptomatology Self-Report 16-Item ([QIDS-SR16] suicide item #12)
Participant has travelled across >3 time zones or >3 hour time difference in the last 2 weeks
History of permanent night shift work or rotating day/night shift work in the past 2 weeks
Body Mass Index (BMI) >40 kg/m^2

About this study

Official title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Long Term Safety Study of MK-4305 in Patients With Primary Insomnia

This study will establish the safety and tolerability of suvorexant (MK-4305) when administered for up to 14 months. Participants will be randomized to receive suvorexant or placebo for a 12-month double-blind (DB) Treatment Phase. Participants who complete the 12-month DB Treatment Phase will enter a 2-month DB Randomized Discontinuation Phase. At the time of initial randomization, participants assigned to receive suvorexant during the initial 12-month Treatment Phase will be simultaneously randomized, in a 1:1 ratio, to receive either suvorexant or placebo during the 2-month Randomized Discontinuation Phase. Participants randomized to receive placebo in the initial 12-month Treatment Phase will continue to receive placebo during the 2-month Randomized Discontinuation Phase.

The first 3 nights of the Randomized Discontinuation Phase are referred to as the Run-Out Phase, and will assess rebound and withdrawal.

Conditions: Insomnia
Being tested: Suvorexant, Dose-matched Placebo to Suvorexant
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.

SuvorexantDrug
Also called MK-4305
Oral tablet (30 mg and 10 mg), administered daily before bedtime
Dose-matched Placebo to SuvorexantDrug
Oral tablet, administered daily before bedtime

Study groups in NCT01021813
Study group	Role	What they receive
Suvorexant	Experimental	After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the Treatment Phase. Receives: Drug: Suvorexant; Drug: Dose-matched Placebo to Suvorexant
Placebo	Placebo comparator	After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the Treatment Phase. Receives: Drug: Dose-matched Placebo to Suvorexant

What is being measured

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

Percentage of Participants Who Experienced Cataplexy Adverse Events (AEs) During the Double-Blind (DB) Treatment Phase
Cataplexy is defined as a sudden loss of muscle tone while awake which prevents voluntary movement.
Measured: From the first day of study treatment up to 12 months
Percentage of Participants Who Experienced Sleep Paralysis AEs During the DB Treatment Phase
Sleep paralysis was defined as the inability to perform voluntary muscle movements during sleep. Sleep paralysis adverse events included sleep-onset paralysis (paralysis as one is falling asleep).
Measured: From the first day of study treatment up to 12 months
Percentage of Participants Who Experienced Complex Sleep-related Behaviors AEs During the DB Treatment Phase
Complex sleep-related behaviors were reported as ECIs and were characterized by patients engaging in specific activities while asleep (e.g., eating, drinking, preparing meals, making phone calls, having sex, driving, and sleep walking).
Measured: From the first day of study treatment up to 12 months
Percentage of Participants Who Experienced Falls AEs During the DB Treatment Phase
Falls were adjudicated (to establish whether a fall event was due to cataplexy).
Measured: From the first day of study treatment up to 12 months
Percentage of Participants Who Experienced Suicidal Ideation and/or Behavior AEs During the DB Treatment Phase
Suicidal ideation included suicidal plans, suicidal tendency, death wishes, life weariness, and suicidal intention. Suicidal behaviors included suicide attempts, suicide gesture, and self-injurious behaviour. Suicidal ideation and/or behavior was reported as an AE and considered an ECI.
Measured: From the first day of study treatment up to 12 months
Percentage of Participants Who Experienced Hypnagogic/Hypnopompic Hallucinations AEs During the DB Treatment Phase
Perceptual distortions associated with transitions between wakefulness and sleep were termed as hypnagogic (occurring during the onset of sleep) or hypnopompic (occurring during onset of wakefulness) hallucinations.
Measured: From the first day of study treatment up to 12 months
Percentage of Participants Who Experienced Selected AEs Associated With Potential for Abuse During the DB Treatment Phase
The pre-specified terms which were suggestive of abuse potential on this study included depersonalization (feeling of watching oneself act, while having no control over a situation), derealization (alteration in the perception or experience of the external world so that it seems unreal), dissociation (includes a wide array of experiences from mild detachment from immediate surroundings to more severe detachment from physical and emotional experience), euphoric mood (exaggerated feeling of physical and emotional well-being and optimism not consonant with apparent stimuli or events), mania (state of abnormally elevated or irritable mood, arousal, and/or energy levels), hallucination (perception in the absence of a stimulus which has qualities of real perception), and potential study medication misuse.
Measured: From the first day of study treatment up to 12 months

Secondary outcomes (5)

Percentage of Participants With Withdrawal Symptoms During the DB Run-Out Phase: Tyrer Withdrawal Symptom Questionnaire (WSQ)
Withdrawal effects assessed using Tyrer WSQ, which evaluated the presence/absence and severity of withdrawal symptoms with 20 items (i.e. sensitivity to noise, light, smell, touch, feeling unreal, etc). The Tyrer WSQ was completed as part of the evening e-diary prior to dosing on the Month 12 visit and on the 3 consecutive evenings of the DB Run-out Phase (first 3 nights of DB Discontinuation Phase). Responses rated 0 (No), 1 (Yes-moderate), or 2 (Yes-severe); range from 0 (no withdrawal) to 40 (severe withdrawal).
A participant was defined to have a withdrawal symptom if an item during any of the 3 DB Run-out days had emerged for the first time, or had worsened compared to the measurement obtained at the end of the Treatment phase (Month 12). For single night analysis, a patient was defined to have withdrawal effects if the number of withdrawal symptoms (emergent or worsening) was ≥3. For across night analysis, withdrawal was defined as a total of ≥3 symptoms across the 3 nights.
Measured: Evening of Month 12 visit and next 3 consecutive days (Night 1, 2, and 3 of Discontinuation Phase [otherwise known as the Run-out])
Percentage of Participants With Rebound As Defined By Decreased Subjective Total Sleep Time (sTST) During the DB Run-Out Phase
Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia, and was assessed based on subjective total sleep time (sTST) as recorded in the participant's morning e-diary. A strict categorical analysis method (Yes/No) was used in which a participant was considered to have potentially experienced rebound (Yes) if the Morning Diary participant-reported sTST value (in minutes) on any of the 3 nights of the Run-out Phase (first 3 nights of the Discontinuation Phase) occurring after one year of treatment (Month 13) was less than the last value at baseline one year earlier (Month 1).
Measured: Baseline (Month 1) and first 3 days of Randomized Discontinuation Phase (otherwise known as the Run-out, Month 13)
Percentage of Participants With Rebound As Defined By Increased Subjective Time to Sleep Onset (sTSO) During the DB Run-Out Phase
Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia, and was assessed based on subjective time to sleep onset (sTSO) as recorded in the participant's morning e-diary. A strict categorical analysis method (Yes/No) was used in which a participant was considered to have potentially experienced rebound (Yes) if the Morning Diary participant-reported sTSO value (in minutes) on any of the first 3 nights of the Run-out Phase occurring after one year of treatment (Month 13) was greater than the last value at baseline one year earlier (Month 1).
Measured: Baseline (Month 1) and first 3 days of Randomized Discontinuation Phase (otherwise known as the Run-out, Month 13)
Least Squares (LS) Mean Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) During First Month of Treatment Phase
The sTSTm was defined as the average over time of daily e-diary values for a participant's report of the total amount of time spent asleep before waking for the day (measured in minutes). Weekly sTSTm values (Week 1, Week 2, etc.) were the average of the daily e-diary values for the week. A summary value of this measure for Month 1 was obtained by taking the average of weekly sTSTm values for Weeks 1 through 4; (Week 1 + Week 2 + Week 3 + Week 4) ÷ 4. LS Mean Change from Baseline in sTSTm was then calculated at Week 1, Week 2, Week 3, Week 4, and Month 1.
Measured: Baseline, Week 1, Week 2, Week 3, and Week 4
Least Squares (LS) Mean Change From Baseline in Mean Subjective Time To Sleep Onset (sTSOm) During First Month of Treatment Phase
The sTSOm was defined as the average over time of daily e-diary values for a participant's report of the time he or she required to fall asleep (measured in minutes). Weekly sTSOm values (Week 1, Week 2, etc.) were the average of the daily e-diary values for the week. A summary value of this measure for Month 1 was obtained by taking the average of weekly sTSTm values for Weeks 1 through 4; (Week 1 + Week 2 + Week 3 + Week 4) ÷ 4. LS Mean Change from Baseline in sTSOm was then calculated at Week 1, Week 2, Week 3, Week 4, and Month 1.
Measured: Baseline, Week 1, Week 2, Week 3, and Week 4

Timeline

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

10 Dec 20091 Aug 2011

First posted30 Nov 2009 (estimated)
Study start10 Dec 2009
Primary completion17 May 2011
Study completion1 Aug 2011

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.
Publications (3)Papers the sponsor has linked to this study.
Other trials for InsomniaStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 781 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01021813
Sponsor's protocol ID: 4305-009
Other IDs: 2009_696
Status last verified: Aug 2018
First submitted: 25 Nov 2009
Last updated: 21 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Herring WJ, Connor KM, Snyder E, Snavely DB, Zhang Y, Hutzelmann J, Matzura-Wolfe D, Benca RM, Krystal AD, Walsh JK, Lines C, Roth T, Michelson D. Suvorexant in Elderly Patients with Insomnia: Pooled Analyses of Data from Phase III Randomized Controlled Clinical Trials. Am J Geriatr Psychiatry. 2017 Jul;25(7):791-802. doi: 10.1016/j.jagp.2017.03.004. Epub 2017 Mar 8.
PubMed 28427826
Herring WJ, Connor KM, Snyder E, Snavely DB, Zhang Y, Hutzelmann J, Matzura-Wolfe D, Benca RM, Krystal AD, Walsh JK, Lines C, Roth T, Michelson D. Clinical profile of suvorexant for the treatment of insomnia over 3 months in women and men: subgroup analysis of pooled phase-3 data. Psychopharmacology (Berl). 2017 Jun;234(11):1703-1711. doi: 10.1007/s00213-017-4573-1. Epub 2017 Mar 7.
PubMed 28265715
Michelson D, Snyder E, Paradis E, Chengan-Liu M, Snavely DB, Hutzelmann J, Walsh JK, Krystal AD, Benca RM, Cohn M, Lines C, Roth T, Herring WJ. Safety and efficacy of suvorexant during 1-year treatment of insomnia with subsequent abrupt treatment discontinuation: a phase 3 randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2014 May;13(5):461-71. doi: 10.1016/S1474-4422(14)70053-5. Epub 2014 Mar 27.
PubMed 24680372

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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Long Term Safety Study of MK-4305 in Patients With Primary Insomnia
ClinicalTrials.gov ID: NCT01021813
Acronym / sponsor ID: 4305-009
Conditions: Insomnia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 781 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 10 Dec 2009 (actual)
Primary completion: 17 May 2011 (actual)
Study completion: 1 Aug 2011 (actual)
First posted: 30 Nov 2009 (estimated)
Results: Posted 29 Aug 2014

Clinical summary

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

The first 3 nights of the Randomized Discontinuation Phase are referred to as the Run-Out Phase, and will assess rebound and withdrawal.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Suvorexant	Experimental	Drug: Suvorexant, Drug: Dose-matched Placebo to SuvorexantAfter a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the Treatment Phase.
Placebo	Placebo comparator	Drug: Dose-matched Placebo to SuvorexantAfter a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the Treatment Phase.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Diagnosis of primary insomnia
Participant is able to read, understand, and complete questionnaires and diaries
If female, participant and partner both agree to use acceptable contraception. If male partner does not use an effective form of contraception, female participant must use 2 acceptable forms of contraception
If ≥65 years of age, score of ≥25 on the Mini Mental State Examination (MMSE)

Key exclusion criteria (12 listed)

If female, participant is pregnant
Participant expects to donate eggs or sperm during the study
Recent and/or active history of a confounding neurological disorder
History of clinically unstable cardiovascular disorder within the last 6 months
Lifetime history of bipolar disorder

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
SuvorexantAlso: MK-4305Oral tablet (30 mg and 10 mg), administered daily before bedtime	Drug	Suvorexant
Dose-matched Placebo to SuvorexantOral tablet, administered daily before bedtime	Drug	Placebo, Suvorexant

Primary outcome

Percentage of Participants Who Experienced Cataplexy Adverse Events (AEs) During the Double-Blind (DB) Treatment Phase
Time frame: From the first day of study treatment up to 12 months
Cataplexy is defined as a sudden loss of muscle tone while awake which prevents voluntary movement.
Percentage of Participants Who Experienced Sleep Paralysis AEs During the DB Treatment Phase
Time frame: From the first day of study treatment up to 12 months
Sleep paralysis was defined as the inability to perform voluntary muscle movements during sleep. Sleep paralysis adverse events included sleep-onset paralysis (paralysis as one is falling asleep).
Percentage of Participants Who Experienced Complex Sleep-related Behaviors AEs During the DB Treatment Phase
Time frame: From the first day of study treatment up to 12 months
Complex sleep-related behaviors were reported as ECIs and were characterized by patients engaging in specific activities while asleep (e.g., eating, drinking, preparing meals, making phone calls, having sex, driving, and sleep walking).
Percentage of Participants Who Experienced Falls AEs During the DB Treatment Phase
Time frame: From the first day of study treatment up to 12 months
Falls were adjudicated (to establish whether a fall event was due to cataplexy).
Percentage of Participants Who Experienced Suicidal Ideation and/or Behavior AEs During the DB Treatment Phase
Time frame: From the first day of study treatment up to 12 months
Suicidal ideation included suicidal plans, suicidal tendency, death wishes, life weariness, and suicidal intention. Suicidal behaviors included suicide attempts, suicide gesture, and self-injurious behaviour. Suicidal ideation and/or behavior was reported as an AE and considered an ECI.
Percentage of Participants Who Experienced Hypnagogic/Hypnopompic Hallucinations AEs During the DB Treatment Phase
Time frame: From the first day of study treatment up to 12 months
Perceptual distortions associated with transitions between wakefulness and sleep were termed as hypnagogic (occurring during the onset of sleep) or hypnopompic (occurring during onset of wakefulness) hallucinations.
Percentage of Participants Who Experienced Selected AEs Associated With Potential for Abuse During the DB Treatment Phase
Time frame: From the first day of study treatment up to 12 months
The pre-specified terms which were suggestive of abuse potential on this study included depersonalization (feeling of watching oneself act, while having no control over a situation), derealization (alteration in the perception or experience of the external world so that it seems unreal), dissociation (includes a wide array of experiences from mild detachment from immediate surroundings to more severe detachment from physical and emotional experience), euphoric mood (exaggerated feeling of physical and emotional well-being and optimism not consonant with apparent stimuli or events), mania (state of abnormally elevated or irritable mood, arousal, and/or energy levels), hallucination (perception in the absence of a stimulus which has qualities of real perception), and potential study medication misuse.

5 secondary outcomes

Percentage of Participants With Withdrawal Symptoms During the DB Run-Out Phase: Tyrer Withdrawal Symptom Questionnaire (WSQ)
Time frame: Evening of Month 12 visit and next 3 consecutive days (Night 1, 2, and 3 of Discontinuation Phase [otherwise known as the Run-out])
Percentage of Participants With Rebound As Defined By Decreased Subjective Total Sleep Time (sTST) During the DB Run-Out Phase
Time frame: Baseline (Month 1) and first 3 days of Randomized Discontinuation Phase (otherwise known as the Run-out, Month 13)
Percentage of Participants With Rebound As Defined By Increased Subjective Time to Sleep Onset (sTSO) During the DB Run-Out Phase
Time frame: Baseline (Month 1) and first 3 days of Randomized Discontinuation Phase (otherwise known as the Run-out, Month 13)
Least Squares (LS) Mean Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) During First Month of Treatment Phase
Time frame: Baseline, Week 1, Week 2, Week 3, and Week 4
Least Squares (LS) Mean Change From Baseline in Mean Subjective Time To Sleep Onset (sTSOm) During First Month of Treatment Phase
Time frame: Baseline, Week 1, Week 2, Week 3, and Week 4

Results and safety

Results posted to the registry on 29 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Suvorexant	522	322
Placebo	259	162
Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation)	0	0
Suvorexant (DB Treatment)/Placebo (DB Discontinuation)	0	0
Placebo (DB Treatment)/Placebo (DB Discontinuation)	0	0

Primary outcome: Percentage of Participants Who Experienced Cataplexy Adverse Events (AEs) During the Double-Blind (DB) Treatment Phase

Time frame: From the first day of study treatment up to 12 months. Number. Unit: percentage of participants

Measure	Suvorexant n = 521	Placebo n = 258
Value	0.0	0.0

Population analysed: All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.

Primary outcome: Percentage of Participants Who Experienced Sleep Paralysis AEs During the DB Treatment Phase

Time frame: From the first day of study treatment up to 12 months. Number. Unit: percentage of participants

Measure	Suvorexant n = 521	Placebo n = 258
Value	0.4	0.0

Suvorexant vs Placebo: Difference in Percentage: 0.4 (95% CI -1.1 to 1.4), Miettinen & Nurminen Method.

Population analysed: All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment

Primary outcome: Percentage of Participants Who Experienced Complex Sleep-related Behaviors AEs During the DB Treatment Phase

Time frame: From the first day of study treatment up to 12 months. Number. Unit: percentage of participants

Measure	Suvorexant n = 521	Placebo n = 258
any complex sleep-related behaviors	0.2	0.0
somnambulism	0.2	0.0

Suvorexant vs Placebo: Difference in Percentage: 0.2 (95% CI -1.3 to 1.1), p = 0.482, Miettinen & Nurminen Method.

Population analysed: All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.

Primary outcome: Percentage of Participants Who Experienced Falls AEs During the DB Treatment Phase

Time frame: From the first day of study treatment up to 12 months. Number. Unit: percentage of participants

Measure	Suvorexant n = 521	Placebo n = 258
Value	2.3	3.1

Suvorexant vs Placebo: Difference in Percentage: -0.8 (95% CI -3.9 to 1.5), p = 0.508, Miettinen & Nurminen Method

Population analysed: All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were monitored from the time of the Prestudy Visit (~Study Day -14) up to the completion of the Follow-up call, occurring 14 days after Randomized Discontinuation Phase (~Study Day 420) or after the last dose of medication, whichever point was later.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Suvorexant	27 of 521 (5.2%)	184 of 521 (35.3%)	Not reported
Placebo	17 of 258 (6.6%)	63 of 258 (24.4%)	Not reported
Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation)	3 of 156 (1.9%)	7 of 156 (4.5%)	Not reported
Suvorexant (DB Treatment)/Placebo (DB Discontinuation)	1 of 166 (0.6%)	5 of 166 (3%)	Not reported
Placebo (DB Treatment)/Placebo (DB Discontinuation)	1 of 162 (0.6%)	9 of 162 (5.6%)	Not reported
Suvorexant (DB Treatment)/Suvorexant (DB Run-out)/Follow-up	1 of 260 (0.4%)	2 of 260 (0.8%)	Not reported
Suvorexant (DB Treatment)/Placebo (DB Run-out)/Follow-up	0 of 261 (0%)	1 of 261 (0.4%)	Not reported
Placebo (DB Treatment)/Placebo (DB Run-out)/Follow-up	2 of 258 (0.8%)	2 of 258 (0.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28427826Herring WJ, Connor KM, Snyder E, Snavely DB, Zhang Y, Hutzelmann J, Matzura-Wolfe D, Benca RM, Krystal AD, Walsh JK, Lines C, Roth T, Michelson D. Suvorexant in Elderly Patients with Insomnia: Pooled Analyses of Data from Phase III Randomized Controlled Clinical Trials. Am J Geriatr Psychiatry. 2017 Jul;25(7):791-802. doi: 10.1016/j.jagp.2017.03.004. Epub 2017 Mar 8.
Derived from this study: PubMed 28265715Herring WJ, Connor KM, Snyder E, Snavely DB, Zhang Y, Hutzelmann J, Matzura-Wolfe D, Benca RM, Krystal AD, Walsh JK, Lines C, Roth T, Michelson D. Clinical profile of suvorexant for the treatment of insomnia over 3 months in women and men: subgroup analysis of pooled phase-3 data. Psychopharmacology (Berl). 2017 Jun;234(11):1703-1711. doi: 10.1007/s00213-017-4573-1. Epub 2017 Mar 7.
Derived from this study: PubMed 24680372Michelson D, Snyder E, Paradis E, Chengan-Liu M, Snavely DB, Hutzelmann J, Walsh JK, Krystal AD, Benca RM, Cohn M, Lines C, Roth T, Herring WJ. Safety and efficacy of suvorexant during 1-year treatment of insomnia with subsequent abrupt treatment discontinuation: a phase 3 randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2014 May;13(5):461-71. doi: 10.1016/S1474-4422(14)70053-5. Epub 2014 Mar 27.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Suvorexant in people with Insomnia, run by Merck Sharp & Dohme LLC.

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 4 inclusion and 12 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 21 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 29 Aug 2014). 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?

Percentage of Participants Who Experienced Cataplexy Adverse Events (AEs) During the Double-Blind (DB) Treatment Phase (time frame: From the first day of study treatment up to 12 months). The study lists 7 primary outcomes in all. 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 NCT01021813, which also lists 3 linked publications.

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 21 Sep 2018.