Migraine DisordersPhase 3NCT00447369
Efficacy of Pregabalin in Migraine Prevention
A Phase 3 study testing Pregabalin and sodium valproate in people with Migraine Disorders, run by Hospital Militar del General Luis Felipe Brieba Aran at 1 site in Chile.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of pregabalin in comparison with sodium valproate in migraine prevention with a randomized blinded crossover study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Pregabalin and sodium valproate
- How many people
- 70 participants
- Where
- 1 siteChile
- Study dates
- May 2007to Mar 2008
- Phase
- Phase 3
- 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
- Migraine with or without aura according to International Headache Society (IHS) criteria for at least 6 months before study entry.
- Frequency of 3 or more headache attacks per month and less than 15 headache attacks per month.
- Available for follow-up at least 9 months.
Who cannot join
- Patients with headache others than migraine.
- Patients failed to respond to more than 2 adequate previous regimen of migraine-preventive medications.
- Prophylactic drugs for migraine 12 weeks before randomization.
- Onset of migraine occurred after 50 years.
- Hypersensitivity to pregabalin or sodium valproate.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Hospital Militar del General Luis Felipe Brieba Aran
Santiago, Reg. Metropolitana, 751-0021
About this study
The purpose of this study is to evaluate the efficacy and safety of pregabalin in comparison with sodium valproate in migraine prevention with a randomized blinded crossover study.
Read the detailed description
The anticonvulsants are effective in the treatment of migraine prevention. The sodium valproate has demonstrated to be effective as monotherapy for migraine prevention in placebo-controlled trials. Besides, other new drugs like gabapentin have been used in the prevention of migraine with a good level of evidence. The pregabalin is an anticonvulsant that has not been proved to use in migraine prevention and it has a similar action mechanisms of the gabapentin. The purpose of this study is the comparison of the effect of pregabalin and sodium valproate in migraine prevention in a randomized blinded crossover study.
- Conditions
- Migraine Disorders
- Being tested
- Pregabalin, sodium valproate
- Keywords
- pregabalin, Valproic acid, migraine, prophylaxis, prevention, treatment
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
sodium valproateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
days with migraine
Secondary outcomes (4)
hours with migraine
headache severity index
level of disability
reports of adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2007 (estimated)
- Study startMay 2007
- Study completionMar 2008 (estimated)
Why it stopped: Because we did not find funds to do it
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 Migraine DisordersStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Militar del General Luis Felipe Brieba Aran
- Sponsor type
- University, hospital or other
- Investigators
- Norberto Bilbeny, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447369
- Sponsor's protocol ID
- HM-PN-001
- Status last verified
- May 2008
- First submitted
- 13 Mar 2007
- Last updated
- 9 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mathew NT, Rapoport A, Saper J, Magnus L, Klapper J, Ramadan N, Stacey B, Tepper S. Efficacy of gabapentin in migraine prophylaxis. Headache. 2001 Feb;41(2):119-28. doi: 10.1046/j.1526-4610.2001.111006119.x.
PubMed 11251695
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pregabalin in Migraine Prevention
- ClinicalTrials.gov ID
- NCT00447369
- Acronym / sponsor ID
- HM-PN-001
- Conditions
- Migraine Disorders
- Keywords
- pregabalin, Valproic acid, migraine, prophylaxis, prevention, treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Because we did not find funds to do it
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hospital Militar del General Luis Felipe Brieba AranUniversity, hospital or other
- Study start
- May 2007
- Study completion
- Mar 2008 (estimated)
- First posted
- 14 Mar 2007 (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 purpose of this study is to evaluate the efficacy and safety of pregabalin in comparison with sodium valproate in migraine prevention with a randomized blinded crossover study.
Detailed description
The anticonvulsants are effective in the treatment of migraine prevention. The sodium valproate has demonstrated to be effective as monotherapy for migraine prevention in placebo-controlled trials. Besides, other new drugs like gabapentin have been used in the prevention of migraine with a good level of evidence. The pregabalin is an anticonvulsant that has not been proved to use in migraine prevention and it has a similar action mechanisms of the gabapentin. The purpose of this study is the comparison of the effect of pregabalin and sodium valproate in migraine prevention in a randomized blinded crossover study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Migraine with or without aura according to International Headache Society (IHS) criteria for at least 6 months before study entry.
- Frequency of 3 or more headache attacks per month and less than 15 headache attacks per month.
- Available for follow-up at least 9 months.
Key exclusion criteria (5 listed)
- Patients with headache others than migraine.
- Patients failed to respond to more than 2 adequate previous regimen of migraine-preventive medications.
- Prophylactic drugs for migraine 12 weeks before randomization.
- Onset of migraine occurred after 50 years.
- Hypersensitivity to pregabalin or sodium valproate.
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 |
|---|---|---|
| Pregabalin | Drug | – |
| sodium valproate | Drug | – |
Primary outcome
days with migraine
4 secondary outcomes
hours with migraine
headache severity index
level of disability
reports of adverse events
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2008.
- Background: PubMed 11251695Mathew NT, Rapoport A, Saper J, Magnus L, Klapper J, Ramadan N, Stacey B, Tepper S. Efficacy of gabapentin in migraine prophylaxis. Headache. 2001 Feb;41(2):119-28. doi: 10.1046/j.1526-4610.2001.111006119.x.
- International Headache SocietyLink 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.
Norberto Bilbeny, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pregabalin and sodium valproate in people with Migraine Disorders, run by Hospital Militar del General Luis Felipe Brieba Aran at 1 site in Chile.
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 5 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: withdrawn, as of the sponsor's last update on 9 May 2008. 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 Chile. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 withdrawn before enrolling participants, so there are no results.
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?
days with migraine. 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 NCT00447369, 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 9 May 2008.