Photosensitive EpilepsyPhase 2NCT00784212
Effect of BGG492 on EEG in Patients With Photosensitive Epilepsy
A Phase 2 study testing BGG492 in people with Photosensitive Epilepsy, run by Novartis Pharmaceuticals at 4 sites in Germany.
Trial summary
This study will evaluate the efficacy of BGG492 in reducing the sensitivity to flashing lights of patients with photosensitive epilepsy, using EEG as a readout. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Photosensitive Epilepsy
- What is being tested?
- BGG492
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 4 sitesGermany
- Study dates
- Oct 2008to 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of photosensitive epilepsy
Who cannot join
- inconsistent photoparoxysmal response when stimulated by photic stimulation
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Novartis Investigator Site
Bielefeld
Novartis Investigator Site
Kehl-Kork
Novartis Investigator Site
Kiel
Novartis Investigator Site
Radeberg
About this study
Official title: A Multicenter, Single-blind, Within-subject, Placebo-controlled Proof of Concept Study to Assess the Effect of Single Oral Doses of BGG492 on the Photoparoxysmal EEG Response in Patients With Photosensitive Epilepsy
This study will evaluate the efficacy of BGG492 in reducing the sensitivity to flashing lights of patients with photosensitive epilepsy, using EEG as a readout.
- Conditions
- Photosensitive Epilepsy
- Being tested
- BGG492, Placebo
- Keywords
- Photosensitive Epilepsy, photic stimulation, electroencephalogram
- Medical subject headings
- Epilepsy, Reflex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGG492Drug
BGG492Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Not described Receives: Drug: BGG492 |
| Cohort II | Experimental | Not described Receives: Drug: BGG492 |
| Cohort III | Experimental | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome Measure: Photoparoxysmal response (PPR) and standardized photoparoxysmal response (SPR) determined by EEG on all treatment days.
Measured: Days 1, 2 and 3
Secondary outcomes (1)
Outcome Measure: Safety and tolerability of BGG492 in patients with photosensitive epilepsy
Measured: From Day 1 until Day 33 after treatment start.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionSep 2010
- Study completionSep 2010
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 Photosensitive EpilepsyStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis, Principal investigator, Novartis Investigator Site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00784212
- Sponsor's protocol ID
- CBGG492A2203
- Other IDs
- 2007-005418-38
- Status last verified
- Sep 2016
- First submitted
- 31 Oct 2008
- Last updated
- 23 Sep 2016
- Results posted
- No
Publications
Kasteleijn-Nolst Trenite D, Brandt C, Mayer T, Rosenow F, Schmidt B, Steinhoff BJ, Gardin A, Imbert G, Johns D, Sagkriotis A, Kucher K. Dose-dependent suppression of human photoparoxysmal response with the competitive AMPA/kainate receptor antagonist BGG492: Clear PK/PD relationship. Epilepsia. 2015 Jun;56(6):924-32. doi: 10.1111/epi.13008. Epub 2015 May 11.
PubMed 25963722
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-blind, Within-subject, Placebo-controlled Proof of Concept Study to Assess the Effect of Single Oral Doses of BGG492 on the Photoparoxysmal EEG Response in Patients With Photosensitive Epilepsy
- ClinicalTrials.gov ID
- NCT00784212
- Acronym / sponsor ID
- CBGG492A2203
- Conditions
- Photosensitive Epilepsy
- Keywords
- Photosensitive Epilepsy, photic stimulation, electroencephalogram
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 3 Nov 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.
This study will evaluate the efficacy of BGG492 in reducing the sensitivity to flashing lights of patients with photosensitive epilepsy, using EEG as a readout.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: BGG492 |
| Cohort II | Experimental | Drug: BGG492 |
| Cohort III | Experimental | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of photosensitive epilepsy
Key exclusion criteria (2 listed)
- inconsistent photoparoxysmal response when stimulated by photic stimulation
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| BGG492 | Drug | Cohort 1 |
| BGG492 | Drug | Cohort II |
| Placebo | Drug | Cohort III |
Primary outcome
Outcome Measure: Photoparoxysmal response (PPR) and standardized photoparoxysmal response (SPR) determined by EEG on all treatment days.
Time frame: Days 1, 2 and 3
1 secondary outcome
Outcome Measure: Safety and tolerability of BGG492 in patients with photosensitive epilepsy
Time frame: From Day 1 until Day 33 after treatment start.
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 23 Sep 2016.
- Derived from this study: PubMed 25963722Kasteleijn-Nolst Trenite D, Brandt C, Mayer T, Rosenow F, Schmidt B, Steinhoff BJ, Gardin A, Imbert G, Johns D, Sagkriotis A, Kucher K. Dose-dependent suppression of human photoparoxysmal response with the competitive AMPA/kainate receptor antagonist BGG492: Clear PK/PD relationship. Epilepsia. 2015 Jun;56(6):924-32. doi: 10.1111/epi.13008. Epub 2015 May 11.
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.
Novartis principal investigator
Novartis Investigator Site
4 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 BGG492 in people with Photosensitive Epilepsy, run by Novartis Pharmaceuticals at 4 sites 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 1 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 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. 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?
Outcome Measure: Photoparoxysmal response (PPR) and standardized photoparoxysmal response (SPR) determined by EEG on all treatment days. (time frame: Days 1, 2 and 3). 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 NCT00784212, 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 23 Sep 2016; AzTrials last refreshed its copy on 8 Nov 2026.