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EpilepsyPhase 2NCT03780907

Safety and Pharmacokinetics Study of E2007 to Treat Partial and Generalised Seizures in People With Epilepsy

A Phase 2 study testing E2007 in people with Epilepsy, run by Eisai Co., Ltd. at 1 site in Germany.

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

The objectives of this study were to assess the tolerability and safety of E2007 in patients with refractory partial or generalised seizures and to assess the pharmacokinetics of E2007 in epileptic patients receiving at least one concomitant anti-epileptic drug. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Epilepsy
What is being tested?
E2007
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
1 siteGermany
Study dates
14 Feb 2003to 6 Aug 2003
Phase
Phase 2
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A patient who met the following inclusion criteria was eligible to participate in the study:
  • Males or females with simple or complex partial seizures with or without secondary generalization, or primary generalized tonic-clonic seizures according to the International League against Epilepsy classification. Patient records were to document the frequency of seizure.
  • Age: 18 to 65 years.
  • Race: any.
  • Patients receiving up to two additional anti-epileptic medications at doses that were stable for at least the four weeks immediately preceding baseline.
  • Patients willing and able to co-operate with the study procedures including completion of patient diaries.
  • Patients living at home with a partner or carer able to monitor compliance.
  • Patients giving informed consent to participate in the study.

Who cannot join

  • A patient who met the following exclusion criteria was not eligible to participate in the study:
  • Pregnant or lactating women.
  • Women of childbearing potential unless (1) surgically sterile or (2) practicing effective contraception (eg, abstinence, IUD or barrier method plus hormonal method) and having a negative serum beta-HCG result at screening and being willing to remain on the current form of contraception for the duration of the study. Postmenopausal women could be included but were to have been amenorrhoeic for at least 12 months to be considered as not being of child-bearing potential.
  • Fertile men not willing to use reliable contraception or with partners not willing to use reliable contraception.
  • Patients with status epilepticus within the past 24 months.
  • Patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, abdominal, haematological, endocrine or metabolic systems which might complicate assessment of the tolerability of the study medication.
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  • Patients with significantly elevated liver enzymes (abnormal bilirubin level, or serum transaminase levels more than 1.5 times the upper limit of normal).
  • Patients taking drugs other than anti-epileptic agents which induce the enzyme cytochrome P450 3A4 (since these might reduce the plasma concentration of E2007), including dexamethasone, rifabutin, rifampacin, St John's Wort.
  • Patients with past or present drug or alcohol abuse.
  • Patients with unstable psychiatric illness.
  • Patients who had received an investigational drug within the three months before baseline.
  • Patients without a reliable partner or carer.
  • Patients with any condition which would make the patient, in the opinion of the investigator, unsuitable for the study.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • 3ClinicalResearch AG

    Hennigsdorf

Other trials in Germany

About this study

Official title: A Randomised, Double-Blind, Placebo-Controlled Study of the Tolerability, Safety and Pharmacokinetics of E2007 in Epileptic Patients With Partial and Generalised Seizures

The objectives of this study were to assess the tolerability and safety of E2007 in patients with refractory partial or generalised seizures and to assess the pharmacokinetics of E2007 in epileptic patients receiving at least one concomitant anti-epileptic drug.

Conditions
Epilepsy
Being tested
E2007, Placebo
Keywords
Epilepsy, E2007, partial seizures, generalized seizures
Medical subject headings
Epilepsy, Seizures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E2007Drug

    1 mg of E2007 was administered by mouth once daily.

  • E2007Drug

    2 mg of E2007 was administered by mouth once daily.

  • PlaceboDrug

    Placebo once daily of oral tablet formulation to be taken in the morning, one hour before breakfast, with a glass of water.

Study groups in NCT03780907
Study groupRoleWhat they receive
E2007 1 mgExperimentalTablet, once daily to be taken in the morning by mouth, one hour before breakfast, with a glass of water.
Receives: Drug: E2007
E2007 2 mgExperimentalTablet, once daily to be taken in the morning by mouth, one hour before breakfast, with a glass of water.
Receives: Drug: E2007
PlaceboPlacebo comparatorTablet, once daily to be taken in the morning, one hour before breakfast, with a glass of water.
Receives: Drug: Placebo

What is being measured

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

  1. Number of participants with Treatment Emergent Adverse Events (TEAEs)

    The TEAEs were defined as those Adverse Events (AEs) that start on or after the first dose of the treatment until the end of the study. AEs were classified by the investigator as 'not related', 'possibly related' or 'probably related'.

    Measured: From administration of first dose of study drug up until 42 days.

  2. Clinical Global Impression of Tolerability (CGIT)

    The investigator's global impressions of the tolerability of the study treatment was based on a five point scale: 1 - very good, 2 - good, 3 - moderate, 4 - poor, and 5 - very poor.

    Measured: Day 28

  3. Pharmacokinetic Parameter: Area Under the Curve (AUC)(0-24hr) of E2007

    Standard pharmacokinetic parameters for E2007 were derived from plasma drug concentrations in epileptic participants. A measure of systemic drug exposure over 24 hours, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.

    Measured: Day 1 and Day 14

  4. Pharmacokinetic Parameter: Cmax (Maximum Observed Plasma Concentration) of E2007

    Standard pharmacokinetic parameters for E2007 were derived from plasma drug concentrations in epileptic participants. The maximum concentration of a drug observed after its administration.

    Measured: Day 1 and Day 14

  5. Pharmacokinetic Parameter: Tmax (Time to Maximum Concentration) of E2007

    Standard pharmacokinetic parameters for E2007 were derived from plasma drug concentrations in epileptic participants. The time after dosing when a drug attains its highest measurable concentration (Cmax).

    Measured: Day 1 and Day 14

  6. Pharmacokinetic Parameter: Css,min (Minimum Steady State Plasma Concentration) of E2007

    Standard pharmacokinetic parameters for E2007 were derived from plasma drug concentrations in epileptic participants. Lowest plasma concentration within a steady-state dosing interval.

    Measured: Day 14

  7. Pharmacokinetic Parameter: Cav (Average Plasma Concentration) of E2007

    Standard pharmacokinetic parameters for E2007 were derived from plasma drug concentrations in epileptic participants.

    Measured: Day 14

  8. Pharmacokinetic Parameter: Peak-to-trough Fluctuation (PTF) of E2007

    Standard pharmacokinetic parameters for E2007 were derived from plasma drug concentrations in epileptic participants.

    Measured: Day 14

  9. Pharmacokinetic Parameter: Observed Accumulation Ratio (Rac) of E2007

    Standard pharmacokinetic parameters for E2007 were derived from plasma drug concentrations in epileptic participants.

    Measured: Day 14

Secondary outcomes (7)

  1. Change from Baseline of Bond and Lader Scale

    The Bond and Lader visual analogue mood scale (VAMS) had a score from 0 - 100; a higher score represented worsening of the participants condition attributed to 3 factors, (1) Anxiety (e.g., calmness), (2) Sedation (e.g., alertness, (3) Dysphoria (e.g., contentedness). The change was visit minus baseline.

    Measured: Baseline, Day 28 and Day 42

  2. Change from Baseline of Peak Saccadic Velocity (PSV)

    Saccadic velocity is the rate of eye movement in response to stimulus. The saccadic eye movement was used to allow comparison of any sedative effects seen.

    Measured: Baseline, Day 28, Day 42

  3. Number of Particpants receiving other Anti-epileptic agents During Treatment

    Measured: Day 1 and Day 14

  4. Percent Change from Baseline of Failed Saccades

    Failed saccades is stimulus resulting in no eye movement above a defined threshold within a specified time.

    Measured: Baseline, Day 28, Day 42

  5. Mean trough concentrations of E2007

    Measured: Day 7, Day 21, and Day 28

  6. Number of seizures

    Measured: Baseline (Day-1) to Day 42

  7. The Clinical Global Impression of Change

    Measured: Day 28

Timeline

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

  1. First posted19 Dec 2018
  2. Study start14 Feb 2003
  3. Primary completion6 Aug 2003
  4. Study completion6 Aug 2003

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03780907
Sponsor's protocol ID
E2007-E049-203
Status last verified
Nov 2015
First submitted
31 Jul 2015
Last updated
19 Dec 2018
Results posted
No
Data monitoring committee
No

Publications

  • Maguire M. Response to "Perampanel and pregnancy: Could experience be a gloomy lantern that does not even illuminate its bearer?". Epilepsy Behav. 2022 Apr;129:108654. doi: 10.1016/j.yebeh.2022.108654. Epub 2022 Mar 16. No abstract available.

    PubMed 35305920

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing E2007 in people with Epilepsy, run by Eisai Co., Ltd. at 1 site in Germany.

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 8 inclusion and 13 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 19 Dec 2018. 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 Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Number of participants with Treatment Emergent Adverse Events (TEAEs) (time frame: From administration of first dose of study drug up until 42 days.). The study lists 9 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 NCT03780907, 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 19 Dec 2018.

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