HealthyPhase 1NCT01530022
Crossover Study of Neuropsychological Effects of Lacosamide and Carbamazepine Immediate Release in Healthy Subjects
A Phase 1 study testing Lacosamide (LCM) and Carbamazepine Immediate Release (CBZ-IR) in people with Healthy, run by UCB Pharma at 2 sites in United States.
Trial summary
The primary objective of this Phase 1 crossover study is to evaluate the neuropsychological effects of Lacosamide (LCM) compared to Carbamazepine Immediate Release (CBZ-IR) after administration in healthy subjects. Safety, tolerability, and pharmacokinetic data will also be collected. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lacosamide (LCM) and Carbamazepine Immediate Release (CBZ-IR)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to Jan 2014
- 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
- Subjects are between 18 and 55 years of age (inclusive)
- Subjects have a Body Mass Index (BMI) between 18 and 35 kg/m^2 (inclusive)
- Subjects must be in generally good health with no clinically relevant health conditions
Who cannot join
- Subject has previously been randomized in this study or subject has received LCM or CBZ
- Subjects may not currently be participating in or have participated in the past 30 days in a clinical drug or device study
- Subjects may not have a history of drug or alcohol abuse within the last 2 years
- Subjects may not consume more than 40 g of alcohol per day
- Females who are pregnant or nursing are ineligible; females of childbearing potential must agree to adhere to protocol conception guidelines
- Subjects may not score ≤ 70 on the Peabody Picture Vocabulary Test (PPVT)
Show all 11Show fewer
- Subjects with a lifetime history of suicide attempt or suicidal ideation in the past 6 months may not participate
- Subjects with a diet that deviates notably from the normal amounts of protein, carbohydrate, and fat, as judged by the investigator are ineligible to participate
- Subjects may not consume more than 600 mg of caffeine/day
- Subjects may not smoke more than 10 cigarettes per day or have done so within 6 months prior to Screening
- Subjects may not have a positive alcohol breath test or urine drug screen at Screening
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Double-dummy, 2-period Crossover Study of Neuropsychological Effects of Lacosamide and Carbamazepine Immediate Release in Healthy Subjects
The primary objective of this Phase 1 crossover study is to evaluate the neuropsychological effects of Lacosamide (LCM) compared to Carbamazepine Immediate Release (CBZ-IR) after administration in healthy subjects. Safety, tolerability, and pharmacokinetic data will also be collected.
Read the detailed description
Approximately 50 subjects at multiple sites will crossover to receive both treatments (lacosamide [LCM]and carbamazepine immediate release [CBZ-IR]) in a randomized order during the 2 study treatment periods (Treatment Period 1 and Treatment Period 2).
A Screening Visit will be conducted to evaluate subject eligibility for enrollment into the study. Eligible subjects will return up to 21 days after the Screening Visit and begin Treatment Period 1. During Visit 2, eligible subjects will be randomized to receive either LCM 300 mg/day or CBZ-IR 600 mg/day. Subjects will be treated with their first randomized Antiepileptic Drug (AED) for 6 weeks (Titration Period [21 days] and Maintenance Period [21 days]). Subjects then complete a 28-day Taper/Washout Period, during which their first AED will be tapered over 4 days followed by a 24-day Washout Period, where subjects will receive no AED. Upon completion of the Taper/Washout Period, subjects will begin Treatment Period 2.The procedures and assessments for Treatment Period 1 will be repeated for Treatment Period 2 (with the same duration of treatment).
- Conditions
- Healthy
- Being tested
- Lacosamide (LCM), Carbamazepine Immediate Release (CBZ-IR)
- Keywords
- Lacosamide, Vimpat, Cognition, Mental Processes, Adverse Effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacosamide (LCM)Drug
Also called Vimpat
LCM 300 mg:
LCM 50 mg and LCM 100 mg white, film-coated oral tablets and Carbamazepine Immediate Release (CBZ-IR) matching placebo capsules.
Two times daily (morning and evening) during the first 2 weeks of each Titration Period and during the Taper Phases.
Three times daily (morning, mid-day, and evening) during last week of each Titration Period and 3-week Treatment Period
Carbamazepine Immediate Release (CBZ-IR)Drug
Also called Tegretol IR
CBZ-IR 600 mg:
CBZ-IR 200 mg oral tablets over-encapsulated to double-blind capsules with an overfill.
LCM matching placebo tablets two times daily (morning and evening) during the first 2 weeks of each Titration Period and during the Taper Phases.
Three times daily (morning, mid-day, and evening) during last week of each Titration Period and 3-week Treatment Period.
| Study group | Role | What they receive |
|---|---|---|
| LCM 300 mg/CBZ-IR 600 mg | Other | Crossover sequence of experimental treatment and active comparator Receives: Drug: Lacosamide (LCM); Drug: Carbamazepine Immediate Release (CBZ-IR) |
| CBZ-IR 600 mg/LCM 300 mg | Other | Crossover sequence of active comparator and experimental treatment Receives: Drug: Lacosamide (LCM); Drug: Carbamazepine Immediate Release (CBZ-IR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Within-subject Difference In The Overall Neuropsychological Composite Score During Both Treatment Periods
The overall composite score will be computed as the sum of the individual cognitive test scores from computerized tests and non-computerized neuropsychological tests (including behavioral questionnaires) after transformation to a Z-scores to form an overall composite Z-score. The Z-score will be calculated using the values (mean and standard deviation) from the average of the scores from 3 non-drug conditions (Baseline, first Washout Period, and second Washout Period).
Measured: From 6-week Treatment Period 1 to 6-week Treatment Period 2 (Visit 1- Visit 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2014
- Study completionJan 2014
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 HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, 877-822-9493
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530022
- Sponsor's protocol ID
- SP0998
- Status last verified
- Jan 2014
- First submitted
- 6 Feb 2012
- Last updated
- 24 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Meador KJ, Loring DW, Boyd A, Echauz J, LaRoche S, Velez-Ruiz N, Korb P, Byrnes W, Dilley D, Borghs S, De Backer M, Story T, Dedeken P, Webster E. Randomized double-blind comparison of cognitive and EEG effects of lacosamide and carbamazepine. Epilepsy Behav. 2016 Sep;62:267-75. doi: 10.1016/j.yebeh.2016.07.007. Epub 2016 Aug 10.
PubMed 27517350
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Double-dummy, 2-period Crossover Study of Neuropsychological Effects of Lacosamide and Carbamazepine Immediate Release in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01530022
- Acronym / sponsor ID
- SP0998
- Conditions
- Healthy
- Keywords
- Lacosamide, Vimpat, Cognition, Mental Processes, Adverse Effects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 9 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.
The primary objective of this Phase 1 crossover study is to evaluate the neuropsychological effects of Lacosamide (LCM) compared to Carbamazepine Immediate Release (CBZ-IR) after administration in healthy subjects. Safety, tolerability, and pharmacokinetic data will also be collected.
Detailed description
Approximately 50 subjects at multiple sites will crossover to receive both treatments (lacosamide [LCM]and carbamazepine immediate release [CBZ-IR]) in a randomized order during the 2 study treatment periods (Treatment Period 1 and Treatment Period 2).
A Screening Visit will be conducted to evaluate subject eligibility for enrollment into the study. Eligible subjects will return up to 21 days after the Screening Visit and begin Treatment Period 1. During Visit 2, eligible subjects will be randomized to receive either LCM 300 mg/day or CBZ-IR 600 mg/day. Subjects will be treated with their first randomized Antiepileptic Drug (AED) for 6 weeks (Titration Period [21 days] and Maintenance Period [21 days]). Subjects then complete a 28-day Taper/Washout Period, during which their first AED will be tapered over 4 days followed by a 24-day Washout Period, where subjects will receive no AED. Upon completion of the Taper/Washout Period, subjects will begin Treatment Period 2.The procedures and assessments for Treatment Period 1 will be repeated for Treatment Period 2 (with the same duration of treatment).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LCM 300 mg/CBZ-IR 600 mg | Other | Drug: Lacosamide (LCM), Drug: Carbamazepine Immediate Release (CBZ-IR)Crossover sequence of experimental treatment and active comparator |
| CBZ-IR 600 mg/LCM 300 mg | Other | Drug: Lacosamide (LCM), Drug: Carbamazepine Immediate Release (CBZ-IR)Crossover sequence of active comparator and experimental treatment |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects are between 18 and 55 years of age (inclusive)
- Subjects have a Body Mass Index (BMI) between 18 and 35 kg/m^2 (inclusive)
- Subjects must be in generally good health with no clinically relevant health conditions
Key exclusion criteria (11 listed)
- Subject has previously been randomized in this study or subject has received LCM or CBZ
- Subjects may not currently be participating in or have participated in the past 30 days in a clinical drug or device study
- Subjects may not have a history of drug or alcohol abuse within the last 2 years
- Subjects may not consume more than 40 g of alcohol per day
- Females who are pregnant or nursing are ineligible; females of childbearing potential must agree to adhere to protocol conception guidelines
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 |
|---|---|---|
| Lacosamide (LCM)Also: VimpatLCM 300 mg: LCM 50 mg and LCM 100 mg white, film-coated oral tablets and Carbamazepine Immediate Release (CBZ-IR) matching placebo capsules. Two times daily (morning and evening) during the first 2 weeks of each Titration Period and during the Taper Phases. Three times daily (morning, mid-day, and evening) during last week of each Titration Period and 3-week Treatment Period | Drug | CBZ-IR 600 mg/LCM 300 mg, LCM 300 mg/CBZ-IR 600 mg |
| Carbamazepine Immediate Release (CBZ-IR)Also: Tegretol IRCBZ-IR 600 mg: CBZ-IR 200 mg oral tablets over-encapsulated to double-blind capsules with an overfill. LCM matching placebo tablets two times daily (morning and evening) during the first 2 weeks of each Titration Period and during the Taper Phases. Three times daily (morning, mid-day, and evening) during last week of each Titration Period and 3-week Treatment Period. | Drug | CBZ-IR 600 mg/LCM 300 mg, LCM 300 mg/CBZ-IR 600 mg |
Primary outcome
Mean Within-subject Difference In The Overall Neuropsychological Composite Score During Both Treatment Periods
Time frame: From 6-week Treatment Period 1 to 6-week Treatment Period 2 (Visit 1- Visit 9)
The overall composite score will be computed as the sum of the individual cognitive test scores from computerized tests and non-computerized neuropsychological tests (including behavioral questionnaires) after transformation to a Z-scores to form an overall composite Z-score. The Z-score will be calculated using the values (mean and standard deviation) from the average of the scores from 3 non-drug conditions (Baseline, first Washout Period, and second Washout Period).
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 Jan 2014.
- Derived from this study: PubMed 27517350Meador KJ, Loring DW, Boyd A, Echauz J, LaRoche S, Velez-Ruiz N, Korb P, Byrnes W, Dilley D, Borghs S, De Backer M, Story T, Dedeken P, Webster E. Randomized double-blind comparison of cognitive and EEG effects of lacosamide and carbamazepine. Epilepsy Behav. 2016 Sep;62:267-75. doi: 10.1016/j.yebeh.2016.07.007. Epub 2016 Aug 10.
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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.
UCB Clinical Trial Call Center study director
877-822-9493
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lacosamide (LCM) and Carbamazepine Immediate Release (CBZ-IR) in people with Healthy, run by UCB Pharma at 2 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 3 inclusion and 11 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 Jan 2014. 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 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. 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?
Mean Within-subject Difference In The Overall Neuropsychological Composite Score During Both Treatment Periods (time frame: From 6-week Treatment Period 1 to 6-week Treatment Period 2 (Visit 1- Visit 9)). 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 NCT01530022, 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 24 Jan 2014.