Comparative Study Between Valproate and Memantine in the Prophylactic Management of Episodic Migraine.

• Status: Completed
• Trial end date: 2020-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad Autonoma de San Luis Potosí
• Treatments: Memantine; Valproic Acid

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.