Transient InsomniaPhase 3NCT00163046
A 28-Day Polysomnographic Study of Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance
A Phase 3 study testing Gabapentin in people with Transient Insomnia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to to assess the effect of gabapentin compared to placebo on sleep, using polysomnography along with subjective sleep assessments, in subjects with transient insomnia induced by a sleep phase advance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transient Insomnia
- What is being tested?
- Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2005to Apr 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- 18 years of age or older with occasional sleeplessness in the month prior to screening
Who cannot join
- Current treatment for, or recent history (within 2 years) of, a sleeping disorder including excessive snoring, obstructive sleep apnea or a chronic painful condition that interferes with the subject's sleep
- Currently taking or expected to take any of the following during trial: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbiturates, and phencyclidine during their participation in the trial
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pfizer Investigational Site
Glendale, California, 91206
Pfizer Investigational Site
Overland Park, Kansas, 66212
Pfizer Investigational Site
San Diego, California, 92123
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 28-day, Polysomnographic Study of Gabapentin 250 mg in Transient Insomnia Induced by a Sleep Phase Advance
The purpose of this study is to to assess the effect of gabapentin compared to placebo on sleep, using polysomnography along with subjective sleep assessments, in subjects with transient insomnia induced by a sleep phase advance.
- Conditions
- Transient Insomnia
- Being tested
- Gabapentin, Placebo
- 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.
GabapentinDrug
Gabapentin 250 mg oral capsule 30 minutes prior to bedtime for 28 days
PlaceboDrug
Matched placebo 30 minutes prior to bedtime for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Experimental | Not described Receives: Drug: Gabapentin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polysomnographic (PSG) measurement of Wake after Persistent Sleep Onset (WAPSO)
Measured: Day 1
Secondary outcomes (21)
PSG WAPSO
Measured: Day 28
PSG Latency to Persistent Sleep (LPS)
Measured: Days 1 and 28
PSG Sleep Onset Latency (SOL)
Measured: Days 1 and 28
PSG Number of Awakenings (NAW)
Measured: Days 1 and 28
PSG Wake after Sleep Onset (WASO)
Measured: Days 1 and 28
PSG Total Wake Time (TWT) plus Stage 1 Sleep
Measured: Days 1 and 28
PSG Wake Time During Sleep (WTDS)
Measured: Days 1 and 28
PSG Total Sleep Time (TST)
Measured: Days 1 and 28
PSG Sleep Efficiency (SE)
Measured: Days 1 and 28
PSG Percent of Stages 1, 2, 3, 4 and REM sleep
Measured: Days 1 and 28
PSG Percent Slow Wave Sleep (SWS, Stages 3&4 combined)
Measured: Days 1 and 28
Subjective SL
Measured: Days 1 and 28
Subjective NA
Measured: Days 1 and 28
Subjective WASO
Measured: Days 1 and 28
Subjective TST
Measured: Days 1 and 28
Subjective ASR
Measured: Days 1 and 28
Subjective ASQ
Measured: Days 1 and 28
Karolinska Sleep Diary (KSD)-Sleep Quality Index
Measured: Days 1 and 28
KSD individual scores
Measured: Days 1 and 28
Vital signs
Measured: Days 1 and 28
Adverse events
Measured: Through Day 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startOct 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transient 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00163046
- Sponsor's protocol ID
- A9451155
- Status last verified
- Apr 2008
- First submitted
- 8 Sep 2005
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Furey SA, Hull SG, Leibowitz MT, Jayawardena S, Roth T. A randomized, double-blind, placebo-controlled, multicenter, 28-day, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance. J Clin Sleep Med. 2014 Oct 15;10(10):1101-9. doi: 10.5664/jcsm.4110.
PubMed 25317091
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 28-day, Polysomnographic Study of Gabapentin 250 mg in Transient Insomnia Induced by a Sleep Phase Advance
- ClinicalTrials.gov ID
- NCT00163046
- Acronym / sponsor ID
- A9451155
- Conditions
- Transient Insomnia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2005
- Study completion
- Apr 2006 (actual)
- First posted
- 13 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to to assess the effect of gabapentin compared to placebo on sleep, using polysomnography along with subjective sleep assessments, in subjects with transient insomnia induced by a sleep phase advance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Experimental | Drug: Gabapentin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years of age or older with occasional sleeplessness in the month prior to screening
Key exclusion criteria (2 listed)
- Current treatment for, or recent history (within 2 years) of, a sleeping disorder including excessive snoring, obstructive sleep apnea or a chronic painful condition that interferes with the subject's sleep
- Currently taking or expected to take any of the following during trial: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbiturates, and phencyclidine during their participation in the trial
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 |
|---|---|---|
| GabapentinGabapentin 250 mg oral capsule 30 minutes prior to bedtime for 28 days | Drug | Gabapentin |
| PlaceboMatched placebo 30 minutes prior to bedtime for 28 days | Drug | Placebo |
Primary outcome
Polysomnographic (PSG) measurement of Wake after Persistent Sleep Onset (WAPSO)
Time frame: Day 1
21 secondary outcomes
PSG WAPSO
Time frame: Day 28
PSG Latency to Persistent Sleep (LPS)
Time frame: Days 1 and 28
PSG Sleep Onset Latency (SOL)
Time frame: Days 1 and 28
PSG Number of Awakenings (NAW)
Time frame: Days 1 and 28
PSG Wake after Sleep Onset (WASO)
Time frame: Days 1 and 28
PSG Total Wake Time (TWT) plus Stage 1 Sleep
Time frame: Days 1 and 28
PSG Wake Time During Sleep (WTDS)
Time frame: Days 1 and 28
PSG Total Sleep Time (TST)
Time frame: Days 1 and 28
PSG Sleep Efficiency (SE)
Time frame: Days 1 and 28
PSG Percent of Stages 1, 2, 3, 4 and REM sleep
Time frame: Days 1 and 28
PSG Percent Slow Wave Sleep (SWS, Stages 3&4 combined)
Time frame: Days 1 and 28
Subjective SL
Time frame: Days 1 and 28
Subjective NA
Time frame: Days 1 and 28
Subjective WASO
Time frame: Days 1 and 28
Subjective TST
Time frame: Days 1 and 28
Subjective ASR
Time frame: Days 1 and 28
Subjective ASQ
Time frame: Days 1 and 28
Karolinska Sleep Diary (KSD)-Sleep Quality Index
Time frame: Days 1 and 28
KSD individual scores
Time frame: Days 1 and 28
Vital signs
Time frame: Days 1 and 28
Adverse events
Time frame: Through Day 32
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Derived from this study: PubMed 25317091Furey SA, Hull SG, Leibowitz MT, Jayawardena S, Roth T. A randomized, double-blind, placebo-controlled, multicenter, 28-day, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance. J Clin Sleep Med. 2014 Oct 15;10(10):1101-9. doi: 10.5664/jcsm.4110.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Transient Insomnia
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Sleep Restriction Therapy for Insomnia in Primary Health Care
Insomnia
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SM-1 vs. an Active Comparator in A Model of Transient Insomnia
Transient Insomnia
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.
Pfizer CT.gov Call Center study director
Pfizer
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gabapentin in people with Transient Insomnia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 3 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 2 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 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Polysomnographic (PSG) measurement of Wake after Persistent Sleep Onset (WAPSO) (time frame: Day 1). 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 NCT00163046, which also lists 1 linked publication.
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 2 Feb 2021.