MigrainePhase 2NCT00640965
DP-VPA for Migraine Prophylaxis, a Pilot Efficacy Study
A Phase 2 study testing DP-VPA in people with Migraine, run by D-Pharm Ltd. at 6 sites in Israel.
Trial summary
The study will evaluate if DP-VPA, a derivative of valproate (a drug that is commonly used for the prevention of migraine attacks), can reduce the rate of migraine attacks. Migraine patients will take DP-VPA or placebo (an inactive look-alike drug) every morning and will have to report any migraine attacks they have… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Migraine
- What is being tested?
- DP-VPA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 6 sitesIsrael
- Study dates
- Jul 2008to Aug 2009
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects with migraine with or without aura fulfilling the diagnostic criteria of the International Classification of Headache Disorders
- 3 to 6 migraine attacks per month
- Concomitant prophylactic migraine treatment with a beta-blocker or amitriptyline that has been stable in the proceeding 3 months. No changes in this concomitant treatment will be allowed until the end of study follow-up.
- Exclusion criteria (abridged)Chronic migraine (>15 days of migraine/ month).
- Migraine complicated by medication-overuse headache.
- Allergy or hypersensitivity to valproic acid, valproate sodium, or soy.
Show all 19Show fewer
- Known contraindications to valproic acid.
- Pregnancy.
- Breastfeeding female subjects.
- Subjects with significant hepatic dysfunction indicated by SGOT or SGPT >3 times the upper limit of normal at screening.
- Renal impairment indicated by serum creatinine >1.5mg/dL at screening.
- Potentially fertile and sexually active women who do not practice reliable contraception.
- Men who do not practice reliable barrier contraception.
- Concomitant use of antipsychotic, antidepressant or antiepileptic therapy - with the exception of amitriptyline - within 1 month of screening, or a medical condition that is likely to require such treatment during the trial participation.
- An active central nervous system disease deemed to be unstable or progressive during the course of the study that may confound the interpretation of the study results.
- Any medical disorder that may makes the subject unlikely to fully complete the study- Blood coagulation disorder.
- Concomitant drugs known to interact with VPA.- Alcohol or other drugs abuse.
- Therapy with another investigational product within 30 days prior start of study.
- Concomitant participation in another trial or study
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Israel6 sites
Rambam Medical Center
Haifa, 31096
Bnei Zion Medical Centre
Haifa
Wolfson Medical Center
Holon, 58220
Beilinson Medical Centre
Petah Tikva
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Chaim Sheba Medical Center
Tel Litwinsky, 52621
About this study
Official title: Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Two-Arm, Multi-Center Phase II Trial to Assess the Safety, Tolerability, and Efficacy of DP-VPA (up to 900 mg) Once Daily for 10 Weeks in Adult Subjects With Migraine
The study will evaluate if DP-VPA, a derivative of valproate (a drug that is commonly used for the prevention of migraine attacks), can reduce the rate of migraine attacks.
Migraine patients will take DP-VPA or placebo (an inactive look-alike drug) every morning and will have to report any migraine attacks they have during the study's 18-week follow up.
Read the detailed description
The multi-center trial has a double-blind, randomized, placebo-controlled, parallel-group design and will be carried out in Israel. Approximately 40 adult subjects with migraine will be randomly assigned (1:1) to either DP-VPA (maximum of 900mg/day) or placebo. Active and placebo will be administered orally and once-daily on an add-on basis, i.e. other permissible ongoing medications will be continued. Total study duration per subject will be 18 weeks. Subjects will report on their migraine attacks frequency and other attack characteristics using weekly diaries.
- Conditions
- Migraine
- Being tested
- DP-VPA, DP-VPA Placebo
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DP-VPADrug
DP-VPA dose escalation to 900mg, then continued for 8 weeks
DP-VPA PlaceboDrug
Matching Placebo to Active, dose escalation, then continued for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | DP-VPA Receives: Drug: DP-VPA |
| B | Placebo comparator | Not described Receives: Drug: DP-VPA Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine attacks frequency
Measured: 6 months
Secondary outcomes (3)
Migraine days
Measured: 6 months
Responders (subjects with >50% decrease in migraine frequency)
Measured: 6 months
Triptan consumption
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startJul 2008
- Primary completionJun 2009 (estimated)
- Study completionAug 2009 (estimated)
Why it stopped: STUDY WAS NOT STARTED
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- D-Pharm Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gilad Rosenberg, M.D., Study director, D-Pharm Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640965
- Sponsor's protocol ID
- Ptcl-01325
- Status last verified
- May 2009
- First submitted
- 17 Mar 2008
- Last updated
- 5 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Two-Arm, Multi-Center Phase II Trial to Assess the Safety, Tolerability, and Efficacy of DP-VPA (up to 900 mg) Once Daily for 10 Weeks in Adult Subjects With Migraine
- ClinicalTrials.gov ID
- NCT00640965
- Acronym / sponsor ID
- Ptcl-01325
- Conditions
- Migraine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: STUDY WAS NOT STARTED
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- D-Pharm Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 21 Mar 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.
The study will evaluate if DP-VPA, a derivative of valproate (a drug that is commonly used for the prevention of migraine attacks), can reduce the rate of migraine attacks.
Migraine patients will take DP-VPA or placebo (an inactive look-alike drug) every morning and will have to report any migraine attacks they have during the study's 18-week follow up.
Detailed description
The multi-center trial has a double-blind, randomized, placebo-controlled, parallel-group design and will be carried out in Israel. Approximately 40 adult subjects with migraine will be randomly assigned (1:1) to either DP-VPA (maximum of 900mg/day) or placebo. Active and placebo will be administered orally and once-daily on an add-on basis, i.e. other permissible ongoing medications will be continued. Total study duration per subject will be 18 weeks. Subjects will report on their migraine attacks frequency and other attack characteristics using weekly diaries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: DP-VPADP-VPA |
| B | Placebo comparator | Drug: DP-VPA Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Male and female subjects with migraine with or without aura fulfilling the diagnostic criteria of the International Classification of Headache Disorders
- 3 to 6 migraine attacks per month
- Concomitant prophylactic migraine treatment with a beta-blocker or amitriptyline that has been stable in the proceeding 3 months. No changes in this concomitant treatment will be allowed until the end of study follow-up.
- Exclusion criteria (abridged)Chronic migraine (>15 days of migraine/ month).
- Migraine complicated by medication-overuse headache.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| DP-VPADP-VPA dose escalation to 900mg, then continued for 8 weeks | Drug | A |
| DP-VPA PlaceboMatching Placebo to Active, dose escalation, then continued for 8 weeks | Drug | B |
Primary outcome
Migraine attacks frequency
Time frame: 6 months
3 secondary outcomes
Migraine days
Time frame: 6 months
Responders (subjects with >50% decrease in migraine frequency)
Time frame: 6 months
Triptan consumption
Time frame: 6 months
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 5 May 2009.
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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.
Gilad Rosenberg, M.D. study director
D-Pharm Ltd.
6 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 DP-VPA in people with Migraine, run by D-Pharm Ltd. at 6 sites in Israel.
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 19 inclusion and 0 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 5 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Israel. 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 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?
Migraine attacks frequency (time frame: 6 months). 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 5 May 2009.