Comparative Study Between Valproate and Memantine in the Prophylactic Management of Episodic Migraine.
Status:
Completed
Trial end date:
2020-11-30
Target enrollment:
Participant gender:
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.