Central Nervous SystemPhase 1NCT01531920
A Study in Healthy Subjects to Determine the Effects When Alcohol is Administered With Perampanel
A Phase 1 study testing alcohol + perampanel and perampanel + alcohol in people with Central Nervous System, run by Eisai Limited at 1 site in United Kingdom.
Trial summary
A Phase 1 study in healthy subjects to determine the safety, tolerability, psychomotor function, and cognitive effects of perampanel when administered alone and with alcohol. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Central Nervous System
- What is being tested?
- alcohol + perampanel and perampanel + alcohol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2010to Apr 2011
- Phase
- Phase 1
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects
- Females agreed to use two medically acceptable methods of contraception, unless they were surgically sterile
- Aged 18-55 yrs, inclusive
- Achieved a Continuous Tracking Test (CTT )score increase of >1.5 pixels from pre-alcohol when dosed with alcohol during the Screening Period (Day minus 8 plus/minus 2 days)
- Had a current driving license and drove regularly (e.g., more than 1000 miles a year (Part B only)
Who cannot join
- Any history of significant alcohol abuse or psychiatric disease, requiring inpatient admission or prolonged treatment with psychotropic medication
- Unable to follow the instructions for the psychometric testing
- Intolerant to the driving simulator (Part B only)
- Unable to adhere to long periods of confinement (subjects who could not follow the instructions of the protocol, including the meals)
- Use of prescription drugs or over-the-counter (OTC) medications within 2 weeks prior to Screening (unless drug had a long half life [i.e., 5 x t 1/2>2 weeks]) with the exception of paracetamol (up to 4 g/day), which was allowed up to 12 hours prior to dosing
- Had taken any inhibitor of CYP450 within 2 weeks prior to the first dosing (e.g., grapefruit, grapefruit juice, grapefruit-containing beverages, or Seville orange products)
- Had taken St John's Wort or other dietary aids known to induce CYP3A4 within 4 weeks prior to dosing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study in Healthy Subjects to Determine the Safety, Tolerability, Psychomotor Function and Cognitive Effects of Perampanel When Administered With Alcohol
A Phase 1 study in healthy subjects to determine the safety, tolerability, psychomotor function, and cognitive effects of perampanel when administered alone and with alcohol.
- Conditions
- Central Nervous System
- Being tested
- alcohol + placebo, alcohol + perampanel, perampanel + alcohol, placebo + alcohol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alcohol + placeboDrug
Part A alcohol + placebo
alcohol + perampanelDrug
Part A: alcohol + perampanel
perampanel + alcoholDrug
Part B: perampanel + alcohol
placebo + alcoholDrug
Part B: placebo + alcohol
| Study group | Role | What they receive |
|---|---|---|
| alcohol + placebo | Other | Part A alcohol + placebo Receives: Drug: alcohol + placebo |
| alcohol + perampanel | Other | Part A : alcohol + perampanel Receives: Drug: alcohol + perampanel |
| perampanel + alcohol | Other | Part B: perampanel + alcohol Receives: Drug: perampanel + alcohol |
| placebo + alcohol | Other | Part B: placebo + alcohol Receives: Drug: placebo + alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Changes on Psychomotor Performance (Continuous Tracking Test [CTT]), due to perampanel and alcohol combined and perampanel alone
Measured: baseline to Part A Day 1
Part B: Changes on Psychomotor Performance (Continuous Tracking Test [CTT]) due to perampanel and alcohol combined and perampanel alone
Measured: baseline to Part B Day 62
Part B:Changes in Cognitive Function due to perampanel and alcohol combined and perampanel alone
Measured: baseline to Part B Day 62
Part B: Part B: Changes in driving performance (simulated) due to perampanel and alcohol combined and perampanel alone
Measured: Part B Day 34
Secondary outcomes (2)
Part A: Incidence of AEs when perampanel is administered in combination with alcohol
Measured: baseline to Part A Day 29
Part B: Incidence of AEs when perampanel is administered in combination with alcohol
Measured: baseline to Part B Day 62
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startMay 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous SystemStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daryl Bendel, Principal investigator, Surrey Clinical Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531920
- Sponsor's protocol ID
- E2007-E044-030
- Status last verified
- Jan 2012
- First submitted
- 9 Feb 2012
- Last updated
- 13 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study in Healthy Subjects to Determine the Safety, Tolerability, Psychomotor Function and Cognitive Effects of Perampanel When Administered With Alcohol
- ClinicalTrials.gov ID
- NCT01531920
- Acronym / sponsor ID
- E2007-E044-030
- Conditions
- Central Nervous System
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Eisai LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 13 Feb 2012 (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.
A Phase 1 study in healthy subjects to determine the safety, tolerability, psychomotor function, and cognitive effects of perampanel when administered alone and with alcohol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| alcohol + placebo | Other | Drug: alcohol + placeboPart A alcohol + placebo |
| alcohol + perampanel | Other | Drug: alcohol + perampanelPart A : alcohol + perampanel |
| perampanel + alcohol | Other | Drug: perampanel + alcoholPart B: perampanel + alcohol |
| placebo + alcohol | Other | Drug: placebo + alcoholPart B: placebo + alcohol |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male and female subjects
- Females agreed to use two medically acceptable methods of contraception, unless they were surgically sterile
- Aged 18-55 yrs, inclusive
- Achieved a Continuous Tracking Test (CTT )score increase of >1.5 pixels from pre-alcohol when dosed with alcohol during the Screening Period (Day minus 8 plus/minus 2 days)
- Had a current driving license and drove regularly (e.g., more than 1000 miles a year (Part B only)
Key exclusion criteria (7 listed)
- Any history of significant alcohol abuse or psychiatric disease, requiring inpatient admission or prolonged treatment with psychotropic medication
- Unable to follow the instructions for the psychometric testing
- Intolerant to the driving simulator (Part B only)
- Unable to adhere to long periods of confinement (subjects who could not follow the instructions of the protocol, including the meals)
- Use of prescription drugs or over-the-counter (OTC) medications within 2 weeks prior to Screening (unless drug had a long half life [i.e., 5 x t 1/2>2 weeks]) with the exception of paracetamol (up to 4 g/day), which was allowed up to 12 hours prior to dosing
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 |
|---|---|---|
| alcohol + placeboPart A alcohol + placebo | Drug | alcohol + placebo |
| alcohol + perampanelPart A: alcohol + perampanel | Drug | alcohol + perampanel |
| perampanel + alcoholPart B: perampanel + alcohol | Drug | perampanel + alcohol |
| placebo + alcoholPart B: placebo + alcohol | Drug | placebo + alcohol |
Primary outcome
Part A: Changes on Psychomotor Performance (Continuous Tracking Test [CTT]), due to perampanel and alcohol combined and perampanel alone
Time frame: baseline to Part A Day 1
Part B: Changes on Psychomotor Performance (Continuous Tracking Test [CTT]) due to perampanel and alcohol combined and perampanel alone
Time frame: baseline to Part B Day 62
Part B:Changes in Cognitive Function due to perampanel and alcohol combined and perampanel alone
Time frame: baseline to Part B Day 62
Part B: Part B: Changes in driving performance (simulated) due to perampanel and alcohol combined and perampanel alone
Time frame: Part B Day 34
2 secondary outcomes
Part A: Incidence of AEs when perampanel is administered in combination with alcohol
Time frame: baseline to Part A Day 29
Part B: Incidence of AEs when perampanel is administered in combination with alcohol
Time frame: baseline to Part B Day 62
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 13 Feb 2012.
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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.
Daryl Bendel principal investigator
Surrey Clinical Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing alcohol + perampanel and perampanel + alcohol in people with Central Nervous System, run by Eisai Limited at 1 site in United Kingdom.
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 5 inclusion and 7 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 13 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Part A: Changes on Psychomotor Performance (Continuous Tracking Test [CTT]), due to perampanel and alcohol combined and perampanel alone (time frame: baseline to Part A Day 1). The study lists 4 primary outcomes in all. 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 13 Feb 2012.