Transient InsomniaPhase 3NCT00674752
A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia
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 4 sites in United States.
Trial summary
The purpose of this study is to assess the effect of gabapentin on polysomnographic assessments in 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
- 377 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2006to Aug 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
- Aged >/= 18 years who reported occasional sleeplessness in the month prior to screening
- Females of child-bearing potential using medically-acceptable method of birth control >/= 1 month prior to screening
Who cannot join
- Current or recent history (within 2 years) of sleep disorder (excessive snoring, obstructive sleep apnea, chronic painful condition)
- Currently taking or expected to take any of the following during the trial: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbituates, and phencyclidine
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Pfizer Investigational Site
Atlanta, Georgia, 30342
Pfizer Investigational Site
Cincinnati, Ohio, 45227
Pfizer Investigational Site
Miami, Florida, 33143
Pfizer Investigational Site
Overland Park, Kansas, 66212
About this study
Official title: A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter, Polysomnographic Study Of Gabapentin 250 mg And 500 mg In Transient Insomnia Induced By A Sleep Phase Advance
The purpose of this study is to assess the effect of gabapentin on polysomnographic assessments in 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
GabapentinDrug
Gabapentin 500 mg oral capsule 30 minutes prior to bedtime
PlaceboDrug
Matched placebo oral capsule 30 minutes prior to bedtime
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Gabapentin |
| B | Experimental | Not described Receives: Drug: Gabapentin |
| C | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wake after sleep onset as measured by polysomnography (PSG)
Measured: Hour +8
Secondary outcomes (20)
PSG Latency to Persistent Sleep
Measured: Hour +8
PSG Wake Time During Sleep
Measured: Hour +8
PSG WASO
Measured: Hour +8
PSG Sleep Onset Latency
Measured: Hour +8
Vital signs
Measured: Hour +8
Karolinska Sleep Diary-Sleep (KSD) Quality Index
Measured: Hour +8
KSD individual scores
Measured: Hour +8
PSG NA
Measured: Hour +8
Adverse events
Measured: Hour +13
PSG Total wake time plus Stage 1 sleep
Measured: Hour +8
PSG TST
Measured: Hour +8
PSG Sleep Efficiency
Measured: Hour +8
PSG Percent of Stages 1, 2, 3, 4 and REM sleep
Measured: Hour +8
PSG Percent slow wave sleep (Stages 3&4 combined)
Measured: Hour +8
subjective Sleep Latency
Measured: Hour +8
subjective Number of Awakenings (NA)
Measured: Hour +8
subjective Wake After Sleep Onset (WASO)
Measured: Hour +8
subjective Total Sleep Time (TST)
Measured: Hour +8
subjective Assessment of Sleep Refreshment
Measured: Hour +8
subjective Assessment of Sleep Quality
Measured: Hour +8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2008 (estimated)
- Study startMar 2006
- Study completionAug 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
- 377 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
- NCT00674752
- Sponsor's protocol ID
- A9451157
- Status last verified
- Apr 2011
- First submitted
- 6 May 2008
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosenberg RP, Hull SG, Lankford DA, Mayleben DW, Seiden DJ, Furey SA, Jayawardena S, Roth T. A randomized, double-blind, single-dose, placebo-controlled, multicenter, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance. J Clin Sleep Med. 2014 Oct 15;10(10):1093-100. doi: 10.5664/jcsm.4108.
PubMed 25317090
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, Single-Dose, Placebo-Controlled, Multicenter, Polysomnographic Study Of Gabapentin 250 mg And 500 mg In Transient Insomnia Induced By A Sleep Phase Advance
- ClinicalTrials.gov ID
- NCT00674752
- Acronym / sponsor ID
- A9451157
- Conditions
- Transient Insomnia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 377 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2006
- Study completion
- Aug 2006 (actual)
- First posted
- 8 May 2008 (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 assess the effect of gabapentin on polysomnographic assessments in 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
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Gabapentin |
| B | Experimental | Drug: Gabapentin |
| C | 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 (2 listed)
- Aged >/= 18 years who reported occasional sleeplessness in the month prior to screening
- Females of child-bearing potential using medically-acceptable method of birth control >/= 1 month prior to screening
Key exclusion criteria (2 listed)
- Current or recent history (within 2 years) of sleep disorder (excessive snoring, obstructive sleep apnea, chronic painful condition)
- Currently taking or expected to take any of the following during the trial: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbituates, and phencyclidine
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 | Drug | A |
| GabapentinGabapentin 500 mg oral capsule 30 minutes prior to bedtime | Drug | B |
| PlaceboMatched placebo oral capsule 30 minutes prior to bedtime | Drug | C |
Primary outcome
Wake after sleep onset as measured by polysomnography (PSG)
Time frame: Hour +8
20 secondary outcomes
PSG Latency to Persistent Sleep
Time frame: Hour +8
PSG Wake Time During Sleep
Time frame: Hour +8
PSG WASO
Time frame: Hour +8
PSG Sleep Onset Latency
Time frame: Hour +8
Vital signs
Time frame: Hour +8
Karolinska Sleep Diary-Sleep (KSD) Quality Index
Time frame: Hour +8
KSD individual scores
Time frame: Hour +8
PSG NA
Time frame: Hour +8
Adverse events
Time frame: Hour +13
PSG Total wake time plus Stage 1 sleep
Time frame: Hour +8
PSG TST
Time frame: Hour +8
PSG Sleep Efficiency
Time frame: Hour +8
PSG Percent of Stages 1, 2, 3, 4 and REM sleep
Time frame: Hour +8
PSG Percent slow wave sleep (Stages 3&4 combined)
Time frame: Hour +8
subjective Sleep Latency
Time frame: Hour +8
subjective Number of Awakenings (NA)
Time frame: Hour +8
subjective Wake After Sleep Onset (WASO)
Time frame: Hour +8
subjective Total Sleep Time (TST)
Time frame: Hour +8
subjective Assessment of Sleep Refreshment
Time frame: Hour +8
subjective Assessment of Sleep Quality
Time frame: Hour +8
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 25317090Rosenberg RP, Hull SG, Lankford DA, Mayleben DW, Seiden DJ, Furey SA, Jayawardena S, Roth T. A randomized, double-blind, single-dose, placebo-controlled, multicenter, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance. J Clin Sleep Med. 2014 Oct 15;10(10):1093-100. doi: 10.5664/jcsm.4108.
- 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
Not yet recruitingPhase 2
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
4 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 4 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 2 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 4 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?
Wake after sleep onset as measured by polysomnography (PSG) (time frame: Hour +8). 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 NCT00674752, 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.