NCT00640965

Brief 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 during the study's 18-week follow up.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 21, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

May 5, 2009

Status Verified

May 1, 2009

Enrollment Period

11 months

First QC Date

March 17, 2008

Last Update Submit

May 4, 2009

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

  • Migraine attacks frequency

    6 months

Secondary Outcomes (3)

  • Migraine days

    6 months

  • Responders (subjects with >50% decrease in migraine frequency)

    6 months

  • Triptan consumption

    6 months

Study Arms (2)

A

EXPERIMENTAL

DP-VPA

Drug: DP-VPA

B

PLACEBO COMPARATOR
Drug: DP-VPA Placebo

Interventions

DP-VPADRUG

DP-VPA dose escalation to 900mg, then continued for 8 weeks

A
DP-VPA PlaceboDRUG

Matching Placebo to Active, dose escalation, then continued for 8 weeks

B

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects with migraine with or without aura fulfilling the diagnostic criteria of the International Classification of Headache Disorders
  • 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.

You may not qualify if:

  • Migraine complicated by medication-overuse headache.
  • Allergy or hypersensitivity to valproic acid, valproate sodium, or soy.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Rambam Medical Center

Haifa, 31096, Israel

Location

Bnei Zion Medical Centre

Haifa, Israel

Location

Wolfson Medical Center

Holon, 58220, Israel

Location

Beilinson Medical Centre

Petah Tikva, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

DP-VPA

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Gilad Rosenberg, M.D.

    D-Pharm Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 17, 2008

First Posted

March 21, 2008

Study Start

July 1, 2008

Primary Completion

June 1, 2009

Study Completion

August 1, 2009

Last Updated

May 5, 2009

Record last verified: 2009-05

Locations

IL(6)