MigrainePhase 2NCT00892203
Efficacy and Safety of BGG492 in the Treatment of Migraine
A Phase 2 study testing BGG492 and Sumatriptan in people with Migraine, run by Novartis at 13 sites in 3 countries.
Trial summary
This study will assess the efficacy and safety of BGG492 used to treat migraine pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Migraine
- What is being tested?
- BGG492 and Sumatriptan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 13 sitesin 3 countries
- Study dates
- Apr 2009to Aug 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
- Diagnosis of moderate to severe migraine for at least 1 year
- At least 1 migraine episode, but not more 15 migraine days per month
- Past use of triptans
- Migraine onset before 50 years of age
Who cannot join
- Diagnosis of basilar, ophthalmoplegic or hemiplegic migraine.
- More than 6 non-migraine headaches per month
- Patients receiving migraine prophylaxis treatment
- Patients receiving regular treatment with psychoactive drugs
- Smokers
- Patients with a very high or low body weight Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
Germany10 sites
Novartis Investigative Site
Berlin
Novartis Investigative Site
Essen
Novartis Investigative Site
Göttingen
Novartis Investigator Site
Hamburg
Novartis Investigative Site
Kiel
Novartis Investigative Site
Königstein
Novartis Investigative Site
Munich
Novartis Investigator Site
Munich
Novartis Investigative Site
Münster
Novartis Investigative Site
Würzburg
United States2 sites
California Clinical Trials, 1560 Chevy Chase Drive, Suite 140
Glendale, California, 91206
California Clinical Trials, 15625 Lakewood Boulevard
Paramount, California, 90723
About this study
Official title: A Multi-centre, Randomized, Double-blind, Parallel Group, Active and Placebo Controlled, Proof of Concept Study in Patients With Acute Migraine to Assess the Efficacy, Safety and Tolerability of Single Oral Doses of BGG492
This study will assess the efficacy and safety of BGG492 used to treat migraine pain.
- Conditions
- Migraine
- Being tested
- BGG492, Sumatriptan, Placebo
- Keywords
- Migraine, Headache
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGG492Drug
SumatriptanDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Not described Receives: Drug: BGG492 |
| Comparator | Active comparator | Not described Receives: Drug: Sumatriptan |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in migraine pain
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2009 (estimated)
- Study startApr 2009
- Primary completionAug 2010
- Study completionAug 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 MigraineStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Investigator Site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892203
- Sponsor's protocol ID
- CBGG492A2204
- Other IDs
- 2008-005392-10, 2008
- Status last verified
- Mar 2016
- First submitted
- 1 May 2009
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Gomez-Mancilla B, Brand R, Jurgens TP, Gobel H, Sommer C, Straube A, Evers S, Sommer M, Campos V, Kalkman HO, Hariry S, Pezous N, Johns D, Diener HC; BGG492 Study Group. Randomized, multicenter trial to assess the efficacy, safety and tolerability of a single dose of a novel AMPA receptor antagonist BGG492 for the treatment of acute migraine attacks. Cephalalgia. 2014 Feb;34(2):103-13. doi: 10.1177/0333102413499648. Epub 2013 Aug 20.
PubMed 23963355
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomized, Double-blind, Parallel Group, Active and Placebo Controlled, Proof of Concept Study in Patients With Acute Migraine to Assess the Efficacy, Safety and Tolerability of Single Oral Doses of BGG492
- ClinicalTrials.gov ID
- NCT00892203
- Acronym / sponsor ID
- CBGG492A2204
- Conditions
- Migraine
- Keywords
- Migraine, Headache
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 4 May 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.
This study will assess the efficacy and safety of BGG492 used to treat migraine pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: BGG492 |
| Comparator | Active comparator | Drug: Sumatriptan |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosis of moderate to severe migraine for at least 1 year
- At least 1 migraine episode, but not more 15 migraine days per month
- Past use of triptans
- Migraine onset before 50 years of age
Key exclusion criteria (6 listed)
- Diagnosis of basilar, ophthalmoplegic or hemiplegic migraine.
- More than 6 non-migraine headaches per month
- Patients receiving migraine prophylaxis treatment
- Patients receiving regular treatment with psychoactive drugs
- Smokers
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 | Active |
| Sumatriptan | Drug | Comparator |
| Placebo | Drug | Placebo |
Primary outcome
Reduction in migraine pain
Time frame: 2 hours
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 17 Dec 2020.
- Derived from this study: PubMed 23963355Gomez-Mancilla B, Brand R, Jurgens TP, Gobel H, Sommer C, Straube A, Evers S, Sommer M, Campos V, Kalkman HO, Hariry S, Pezous N, Johns D, Diener HC; BGG492 Study Group. Randomized, multicenter trial to assess the efficacy, safety and tolerability of a single dose of a novel AMPA receptor antagonist BGG492 for the treatment of acute migraine attacks. Cephalalgia. 2014 Feb;34(2):103-13. doi: 10.1177/0333102413499648. Epub 2013 Aug 20.
- Results for CBGG492A2204 from the Novartis Clinical Trials websiteLink 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.
Novartis Pharmaceuticals study director
Novartis Investigator Site
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BGG492 and Sumatriptan in people with Migraine, run by Novartis at 13 sites in 3 countries.
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 4 inclusion and 6 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 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, United States, Spain. 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?
Reduction in migraine pain (time frame: 2 hours). 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 NCT00892203, 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 17 Dec 2020.