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

NCT04698525 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 74-19
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine Headache

Keywords

Episodic MIgraine; Memantine; Valproate; Efficacy; Security; MIDAS; Prophylaxis

Outcome Measures

Primary Outcomes (3)

• Reduction in Days of Headache Pain With Treatment of Memantine or Valproate in the Preventive Management of Episodic Migraine.

  In a double-blind clinical trial, we compared two active drugs (mamantine vs. valproate) three months after initiation, looking for changes in the average number of days of migraine attack presentation per month and comparing the three months before with the three months after treatment administration with two active drugs.

  Three months before treatment (Pretreatment), three months after initiating treatment (post-treatment)

• The Change in the Intensity of the Pain in a Migraine Attack Will be Measured by a Visual Analogue Scale (VAS).

  The possible reduction in the average on the visual analog scale (0-10) comparing three months before and after three months of the treatment with both drugs. We measured both arms of the study. 0 means without pain. 10 means the worst possible pain in the concept of the patient.

  Three months previous and three months after the treatment.

• The Migraine Disability Assessment MIDAS Scale Will Measure Before and After the Treatment to Improve the Quality of Life in Both Groups After Three Months of Treatment.

  To compare the average of Memantine against the group that receives Valproate before and after starting preventive treatment. Using the Migraine Disability Assessment scale (The score is the sum of days missed from work or school, days of housework missed, days of missed non-work activities, and days of work or school plus days of housework in which productivity in the last three months) to compare punctuation changes. The MIDAS score is divided into four degrees, the minimum score is 0 points, and the maximum score is 70. A higher value represents a higher difficulty to carry out a satisfactory lifestyle, and a score higher than 20 points already represents a high limitation to enjoying daily activities: Grade I (0-5 points): Slight limitations and few patient treatment needs. Grade II (6-10 points): Moderate limitations and treatment needs. Grade III (11-20 points) and IV (21 or more points): Severe and significant punctuation treatment needs.

  Three months.

Secondary Outcomes (1)

• Measure Changes in Weight With the Administration of Active Drugs.

  Three months

Other Outcomes (1)

• To Compare the Adverse Events in the Use of Memantine in Comparision With Valpoate in the Episodic Migraine Treatment.

  Three months

Study Arms (2)

Valproate group

ACTIVE COMPARATOR

This is a well know antiepileptic drug with efficacy as a preventive tic treatment in episodic migraine

Drug: Valproate Sodium

Memantine

ACTIVE COMPARATOR

This is a possible preventive treatment in episodic migraine

Drug: Memantine

Interventions

Valproate Sodium DRUG

Comparison between two actives

Also known as: Diwali

Valproate group

Memantine DRUG

Memantine

Also known as: Ezagun

Memantine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women from 18 to 65 years old.
• Diagnosis of migraine according to the ICHD-III of the IHS at least one year before the study.
• You must have at least 4-14 migraine attacks per month.
• Not receiving prophylactic treatment for migraine
• Sign informed consent

You may not qualify if:

• Pregnant or lactating patients.
• Patients with another type of non-migraine headache.
• Allergy to Sodium Valproate and/or Memantine
• Being a carrier of systemic disease (infectious, immunological, or metabolic processes) or cardiovascular (myocardial, coronary, or valvular disease) prevents their participation in the study.

Sponsors & Collaborators

• Universidad Autonoma de San Luis Potosí: lead

Study Sites (1)

Hospital Central Dr. Ignacio Morones Prieto

San Luis Potosí City, 78290, Mexico

Location

Related Publications (6)

• GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.

  PMID: 30496104 BACKGROUND

• Bille B. A 40-year follow-up of school children with migraine. Cephalalgia. 1997 Jun;17(4):488-91; discussion 487. doi: 10.1046/j.1468-2982.1997.1704488.x.

  PMID: 9209767 BACKGROUND

• Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.

  PMID: 29368949 BACKGROUND

• Schwedt TJ. Preventive Therapy of Migraine. Continuum (Minneap Minn). 2018 Aug;24(4, Headache):1052-1065. doi: 10.1212/CON.0000000000000635.

  PMID: 30074549 BACKGROUND

• Linde M, Mulleners WM, Chronicle EP, McCrory DC. Valproate (valproic acid or sodium valproate or a combination of the two) for the prophylaxis of episodic migraine in adults. Cochrane Database Syst Rev. 2013 Jun 24;2013(6):CD010611. doi: 10.1002/14651858.CD010611.

  PMID: 23797677 BACKGROUND

• Noruzzadeh R, Modabbernia A, Aghamollaii V, Ghaffarpour M, Harirchian MH, Salahi S, Nikbakht N, Noruzi N, Tafakhori A. Memantine for Prophylactic Treatment of Migraine Without Aura: A Randomized Double-Blind Placebo-Controlled Study. Headache. 2016 Jan;56(1):95-103. doi: 10.1111/head.12732. Epub 2015 Dec 6.

  PMID: 26638119 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Interventions

Valproic Acid; Memantine

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Ildefonso Rodriguez-Leyva MD, PhD
• Organization: Medicine Faculty, Universidad Autónoma de San Luis Potosi

ildefonso.rodriguez@uaslp.mx

4442043016

Study Officials

• Juan M. Shiguetomi-Medina, MD, PhD

  Facultad de Medicina, Universidad Autonoma de San Luis Potosi

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, FAAN, FANA

Model Details: A double-blind study with two groups. One using VPA and the other one using memantine in subjects with a diagnosis of episodic migraine.

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: January 7, 2021
• Study Start: February 15, 2019
• Primary Completion: January 15, 2020
• Study Completion: January 15, 2020
• Last Updated: May 9, 2024
• Results First Posted: May 17, 2023

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 12 months
• Access Criteria: 6 months

Locations

ME (1)