EpilepsyPhase 2NCT00979004
A Study to Investigate the Effect of ICA-105665 in Photosensitive Epilepsy Patients
A Phase 2 study testing ICA-105665 in people with Epilepsy, run by Pfizer at 3 sites in United States.
Trial summary
Subjects with epilepsy with a documented photoparoxysmal response to intermittent photic stimulation (IPS) will participate. Four subjects will be enrolled at each dose level and will receive a single dose of placebo and a single dose of ICA-105665 during the study, each followed by intermittent photic stimulation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- ICA-105665
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2009to Sep 2010
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A diagnosis and history of epilepsy for which they are on 0-2 concurrent antiepileptic drugs.
- On a stable dose of their current AED(s) for 4 weeks prior to the Screening Visit.
- Must be in good health (with the exception of epilepsy), as determined by the Primary Investigator via the medical history, a physical examination, and screening laboratory investigations.
- A body mass index (BMI) between 18 and 35.
- Able and willing to give written informed consent prior to participation in the study.
- A reproducible IPS-induced photo-paroxysmal EEG response (PPR) of at least 3 points on a frequency assessment scale in at least one eye condition and no change of more than 3 frequencies in 2 repeated measurements recorded at the Screening Visit.
Who cannot join
- History of non-epileptic seizures (metabolic, structural, or pseudoseizures).
- History of status epilepticus while on any antiepileptic medication.
- The etiology of the seizures is due to any of the following; progressive degenerative disease, metabolic illness, active infection, demyelination, drugs, alcohol.
- The subject has used benzodiazepines (oral, intra-muscular, or suppository) as escape medication within the past 6 months.
- The subject has taken an investigational medication within 30 days prior to the Day 1.
- Women who are pregnant or lactating.
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- An active Central Nervous System (CNS) infection, demyelinating disease, degenerative neurological disease or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results.
- The subject has a clinically significant (e.g., cancerous, unstable, progressive, functionally disabling, or infectious) medical condition that would interfere with the ability to complete the study or that might interfere with the absorption, distribution, metabolism, and/or excretion of drugs.
- Subjects with impaired hepatic function [ALT (Alanine aminotransferase), AST (Aspartate aminotransferase) =3 times the upper limit of normal] or any clinically significant laboratory abnormality that, in the opinion of the investigator, would increase the risk of participation or interfere with the interpretatio of the study results.
- History of alcoholism, drug abuse, or drug addiction within the last 12 months.
- Clinically significant psychiatric illness, psychological or behavioral problem which, in the opinion of the investigator would interfere with the subject's ability to participate in the study OR the subject is receiving therapy with neuroleptic drugs.
- Subject experiences a clinical seizure during any IPS procedure performed during the screening period.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pfizer Investigational Site
Chesterfield, Missouri, 63017
Pfizer Investigational Site
Little Rock, Arkansas, 72205
Pfizer Investigational Site
Nashville, Tennessee, 37232
About this study
Official title: A Phase 2, Multi-Center, Single-Blind, Placebo-Controlled Pharmacodynamic Evaluation of ICA-105665 in Epilepsy Patients With a Photo-Induced Paroxysmal EEG Response
Subjects with epilepsy with a documented photoparoxysmal response to intermittent photic stimulation (IPS) will participate. Four subjects will be enrolled at each dose level and will receive a single dose of placebo and a single dose of ICA-105665 during the study, each followed by intermittent photic stimulation. The effects of ICA-105665 on the photoparoxysmal electroencephalography (EEG) response of each group will be reviewed before the dose is selected for each subsequent group of subjects.
- Conditions
- Epilepsy
- Being tested
- ICA-105665
- Keywords
- Photosensitivity, Epilepsy, Seizures
- Medical subject headings
- Epilepsy, Photosensitivity Disorders, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICA-105665Drug
Oral tablet. Dose forms of 50 and 100 mg or placebo will be used. A single dose will be administered that can range from placebo or 100 to 600 mg.
| Study group | Role | What they receive |
|---|---|---|
| ICA-105665 | Experimental | Not described Receives: Drug: ICA-105665 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in photosensitivity response
Measured: begin 1 hr post dose for 8 hours
Secondary outcomes (2)
To correlate plasma concentrations of ICA-105665 with effect on the frequency range of IPS-induced PPR (Photoparoxysmal response) in subjects with photosensitive epilepsy.
Measured: 3 days
To assess the safety of a single dose of ICA-105665 in subjects with photosensitive epilepsy.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: The study was terminated on September 12, 2010 per protocol following a serious adverse event that occurred with the first subject dosed at 600 mg.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- 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
- NCT00979004
- Sponsor's protocol ID
- ICA-105665-04
- Other IDs
- B5311005
- Status last verified
- Sep 2012
- First submitted
- 16 Sep 2009
- Last updated
- 4 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-Center, Single-Blind, Placebo-Controlled Pharmacodynamic Evaluation of ICA-105665 in Epilepsy Patients With a Photo-Induced Paroxysmal EEG Response
- ClinicalTrials.gov ID
- NCT00979004
- Acronym / sponsor ID
- ICA-105665-04
- Conditions
- Epilepsy
- Keywords
- Photosensitivity, Epilepsy, Seizures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated on September 12, 2010 per protocol following a serious adverse event that occurred with the first subject dosed at 600 mg.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 17 Sep 2009 (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.
Subjects with epilepsy with a documented photoparoxysmal response to intermittent photic stimulation (IPS) will participate. Four subjects will be enrolled at each dose level and will receive a single dose of placebo and a single dose of ICA-105665 during the study, each followed by intermittent photic stimulation. The effects of ICA-105665 on the photoparoxysmal electroencephalography (EEG) response of each group will be reviewed before the dose is selected for each subsequent group of subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICA-105665 | Experimental | Drug: ICA-105665 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- A diagnosis and history of epilepsy for which they are on 0-2 concurrent antiepileptic drugs.
- On a stable dose of their current AED(s) for 4 weeks prior to the Screening Visit.
- Must be in good health (with the exception of epilepsy), as determined by the Primary Investigator via the medical history, a physical examination, and screening laboratory investigations.
- A body mass index (BMI) between 18 and 35.
- Able and willing to give written informed consent prior to participation in the study.
Key exclusion criteria (12 listed)
- History of non-epileptic seizures (metabolic, structural, or pseudoseizures).
- History of status epilepticus while on any antiepileptic medication.
- The etiology of the seizures is due to any of the following; progressive degenerative disease, metabolic illness, active infection, demyelination, drugs, alcohol.
- The subject has used benzodiazepines (oral, intra-muscular, or suppository) as escape medication within the past 6 months.
- The subject has taken an investigational medication within 30 days prior to the Day 1.
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 |
|---|---|---|
| ICA-105665Oral tablet. Dose forms of 50 and 100 mg or placebo will be used. A single dose will be administered that can range from placebo or 100 to 600 mg. | Drug | ICA-105665 |
Primary outcome
Change in photosensitivity response
Time frame: begin 1 hr post dose for 8 hours
2 secondary outcomes
To correlate plasma concentrations of ICA-105665 with effect on the frequency range of IPS-induced PPR (Photoparoxysmal response) in subjects with photosensitive epilepsy.
Time frame: 3 days
To assess the safety of a single dose of ICA-105665 in subjects with photosensitive epilepsy.
Time frame: 30 days
Results and safety
The study was stopped early (reason given: The study was terminated on September 12, 2010 per protocol following a serious adverse event that occurred with the first subject dosed at 600 mg.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2012.
- 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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ICA-105665 in people with Epilepsy, run by Pfizer at 3 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 6 inclusion and 12 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: stopped early, as of the sponsor's last update on 4 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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 was stopped early (reason given: The study was terminated on September 12, 2010 per protocol following a serious adverse event that occurred with the first subject dosed at 600 mg.). Results are not available in the source record.
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 in photosensitivity response (time frame: begin 1 hr post dose for 8 hours). 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 4 Oct 2012.