Sleep DeprivationPhase 3NCT00643136
A Study of Lyrica as Treatment for Sleep Problems in Patients With Sleep Problems and Seizures
A Phase 3 study testing Pregabalin in people with Sleep Deprivation and Epilepsies, Partial, run by Pfizer at 2 sites in Netherlands.
Trial summary
The purpose of this study is to determine the effects of pregabalin on sleep problems in patients with seizures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Deprivation, Epilepsies, Partial
- What is being tested?
- Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 2 sitesNetherlands
- Study dates
- Nov 2002to Jun 2004
- 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
- Partial epileptic seizures
- Not taking more than 1 background antiepileptic drug at study entry
- Disturbed sleep
Who cannot join
- More than 1 secondarily generalized tonic/clonic seizure per week on average over the previous 3 months
- Medical, psychological, or social conditions that could interfere with normal sleep
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Pfizer Investigational Site
Heeze, 5591 VE
Pfizer Investigational Site
The Hague, 2501 CK
About this study
Official title: Pregabalin BID Add-on Trial: a Randomized, Double-Blind, Placebo-Controlled Parallel-Group Single-Center Sleep EEG Study in Patients With Partial Seizures and Sleep Disturbance Part B: a Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study of Pregabalin Add-on Treatment
The purpose of this study is to determine the effects of pregabalin on sleep problems in patients with seizures.
- Conditions
- Sleep Deprivation, Epilepsies, Partial
- Being tested
- Pregabalin, Placebo
- Medical subject headings
- Sleep Deprivation, Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Pregabalin capsules 75 mg twice daily on Days 1-4, then 150 mg twice daily on Days 5-28
PlaceboDrug
Matching placebo capsules twice daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin | Experimental | Not described Receives: Drug: Pregabalin |
| 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.
Change from baseline in polysomnographic (PSG) sleep efficiency in the efficacy evaluable population
Measured: Endpoint
Secondary outcomes (8)
Change from baseline in total sleep time
Measured: Endpoint
Change from baseline in sleep onset latency
Measured: Endpoint
Change from baseline in wake after sleep onset
Measured: Endpoint
Change from baseline in percent sleep spent in stages 3 and 4
Measured: Endpoint
Change from baseline in percent sleep spent in REM stage
Measured: Endpoint
Change from baseline in night sleep quality based on Groningen Sleep Questionnaire (GSQ)
Measured: Endpoint
Change from baseline in 4-week sleep quality (Medical Outcomes Study [MOS] Sleep Scale)
Measured: Endpoint
Adverse events and laboratory value changes
Measured: Endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startNov 2002
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643136
- Sponsor's protocol ID
- 1008-000-167
- Status last verified
- Apr 2008
- First submitted
- 19 Mar 2008
- Last updated
- 24 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregabalin BID Add-on Trial: a Randomized, Double-Blind, Placebo-Controlled Parallel-Group Single-Center Sleep EEG Study in Patients With Partial Seizures and Sleep Disturbance Part B: a Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study of Pregabalin Add-on Treatment
- ClinicalTrials.gov ID
- NCT00643136
- Acronym / sponsor ID
- 1008-000-167
- Conditions
- Sleep Deprivation, Epilepsies, Partial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Study completion
- Jun 2004 (actual)
- First posted
- 26 Mar 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 determine the effects of pregabalin on sleep problems in patients with seizures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin | Experimental | Drug: Pregabalin |
| 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 (3 listed)
- Partial epileptic seizures
- Not taking more than 1 background antiepileptic drug at study entry
- Disturbed sleep
Key exclusion criteria (2 listed)
- More than 1 secondarily generalized tonic/clonic seizure per week on average over the previous 3 months
- Medical, psychological, or social conditions that could interfere with normal sleep
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 |
|---|---|---|
| PregabalinPregabalin capsules 75 mg twice daily on Days 1-4, then 150 mg twice daily on Days 5-28 | Drug | Pregabalin |
| PlaceboMatching placebo capsules twice daily for 28 days | Drug | Placebo |
Primary outcome
Change from baseline in polysomnographic (PSG) sleep efficiency in the efficacy evaluable population
Time frame: Endpoint
8 secondary outcomes
Change from baseline in total sleep time
Time frame: Endpoint
Change from baseline in sleep onset latency
Time frame: Endpoint
Change from baseline in wake after sleep onset
Time frame: Endpoint
Change from baseline in percent sleep spent in stages 3 and 4
Time frame: Endpoint
Change from baseline in percent sleep spent in REM stage
Time frame: Endpoint
Change from baseline in night sleep quality based on Groningen Sleep Questionnaire (GSQ)
Time frame: Endpoint
Change from baseline in 4-week sleep quality (Medical Outcomes Study [MOS] Sleep Scale)
Time frame: Endpoint
Adverse events and laboratory value changes
Time frame: Endpoint
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 24 Apr 2008.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
2 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 Pregabalin in people with Sleep Deprivation and Epilepsies, Partial, run by Pfizer at 2 sites in Netherlands.
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 3 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 24 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
Change from baseline in polysomnographic (PSG) sleep efficiency in the efficacy evaluable population (time frame: Endpoint). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2008.