Comparative Study Between Valproate and Memantine in the Prophylactic Management of Episodic Migraine.
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Intervention: Valproate Sodium; Memantine
Intervention description: Comparison between two actives; Memantine
Intervention MeSH terms: Valproic Acid; Memantine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A double-blind study with two groups. One using VPA and the other one using memantine in subjects with a diagnosis of episodic migraine.
Masking: Single (Investigator)
Masking description: The clinician will make an evaluation and if the patient has the criteria for inclusion will be by randomization in one group or another. Neither the clinician and the patient will not know the administrated treatment.
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Episodic MIgraine; Memantine; Valproate; Efficacy; Security; MIDAS; Prophylaxis

Summary:

      Migraine is one of the three most disabling diseases worldwide. Constituted by recurrent
      episodes of headache, characterized by unilateral location, throbbing character, moderate or
      severe intensity, worsening with physical activity, and association with nausea or
      photophobia and/or phonophobia. There are two types of drug treatment: abortifacient and
      prophylactic. The American Academy of Neurology classifies sodium valproate as level A;
      however, some patients do not obtain a satisfactory response rate and/or have adverse
      effects. Therefore, the search for new pharmacological treatments continues. In 2015, a
      double-blind, randomized clinical trial with a placebo was carried out to assess Memantine's
      efficacy in the prophylactic treatment of migraine without aura, which reported a reduction
      of 2.3 migraine attacks per month compared to the placebo group. Memantine could be a new
      effective treatment alternative, which is why we will compare the efficacy of Memantine
      against sodium valproate as a prophylactic migraine treatment.

      Main objective: To compare the efficacy of Memantine at a rate of 20mg divided into two doses
      a day against sodium valproate (VPA) at a rate of 1000mg divided into two doses a day
      prophylactic treatment of migraine for three months.

      Study design: a prospective controlled, randomized, double-blind clinical trial. Inclusion
      criteria: Men and women aged 18 to 65 years with a diagnosis at least one year before the
      study must present at least 2 to 8 migraine attacks per month and less than 15 days with
      headache per month, which should not be receiving prophylactic treatment for migraine and
      sign an informed consent

      Sample size calculation and statistical analysis:

      It is calculated using the normal distribution model, where the recommended sample size is
      196 participants. Since a pilot study will be conducted, 10% of the sample size will be taken
      to make it representative, a sample size of 20 participants is decided for each group.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women from 18 to 65 years old.

          2. Diagnosis of migraine according to the ICHD-III of the IHS at least one year before
             the study.

          3. You must have at least 4-14 migraine attacks per month.

          4. Not receiving prophylactic treatment for migraine

          5. Sign informed consent

        Exclusion Criteria:

          1. Pregnant or lactating patients.

          2. Patients with another type of non-migraine headache.

          3. Allergy to Sodium Valproate and/or Memantine

          4. Being a carrier of systemic disease (infectious, immunological, or metabolic
             processes) or cardiovascular (myocardial, coronary, or valvular disease) prevents
             their participation in the study.