Trial Outcomes & Findings for Comparative Study Between Valproate and Memantine in the Prophylactic Management of Episodic Migraine. (NCT NCT04698525)
NCT ID: NCT04698525
Last Updated: 2024-05-09
Results Overview
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.
COMPLETED
PHASE3
33 participants
Three months before treatment (Pretreatment), three months after initiating treatment (post-treatment)
2024-05-09
Participant Flow
Participant milestones
| Measure |
Valproate Group
VPA is a well know antiepileptic drug with efficacy as a preventive tic treatment in episodic migraine.
Valproate Sodium: Comparison between two actives
There were 17 patients in the valproate group. In both grupus, females represent the majority.
|
Memantine
This is a possible preventive treatment for episodic migraine
Memantine: MemantineThere was 16 patients in the memantine group
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
|
Overall Study
COMPLETED
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Valproate Group
VPA is a well know antiepileptic drug with efficacy as a preventive tic treatment in episodic migraine.
Valproate Sodium: Comparison between two actives
There were 17 patients in the valproate group. In both grupus, females represent the majority.
|
Memantine
This is a possible preventive treatment for episodic migraine
Memantine: MemantineThere was 16 patients in the memantine group
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Three suffered of Covid-19
|
2
|
1
|
Baseline Characteristics
Comparative Study Between Valproate and Memantine in the Prophylactic Management of Episodic Migraine.
Baseline characteristics by cohort
| Measure |
Valproate Group
n=17 Participants
VPA is a well know antiepileptic drug with efficacy as a preventive treatment for episodic migraine.
Valproate Sodium
|
Memantine
n=16 Participants
This is a possible preventive treatment in episodic migraine
Memantine: Memantine
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
31.58 years
STANDARD_DEVIATION 7.51 • n=93 Participants
|
31.18 years
STANDARD_DEVIATION 10.94 • n=4 Participants
|
31.38 years
STANDARD_DEVIATION 9.22 • n=27 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
17 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Mexico
|
17 participants
n=93 Participants
|
16 participants
n=4 Participants
|
33 participants
n=27 Participants
|
|
Pain Localization: hemicranial
Hemicraneal pain
|
13 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Pain Localization: hemicranial
Holocranial pain
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Photophobia
|
16 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Sonophobia
|
10 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Nausea and vomit
|
17 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Disability
|
17 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
With aura
|
13 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Without aura
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Three months before treatment (Pretreatment), three months after initiating treatment (post-treatment)Population: It was a straightforward difference between pre and post-treatment in both groups.
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.
Outcome measures
| Measure |
Valproate Group
n=17 Participants
Comparison between the frequency by month in the three months previous to the starting and the following three months with the use of VPA.
|
Memantine
n=16 Participants
Pretreatment the mean was 5.31 (migraine/days) after treatment was 0.92
|
|---|---|---|
|
Reduction in Days of Headache Pain With Treatment of Memantine or Valproate in the Preventive Management of Episodic Migraine.
Pretreatment
|
5.35 Migraine days by month.
Standard Deviation 1.11
|
5.31 Migraine days by month.
Standard Deviation 1.5
|
|
Reduction in Days of Headache Pain With Treatment of Memantine or Valproate in the Preventive Management of Episodic Migraine.
Post-treatment
|
0.77 Migraine days by month.
Standard Deviation 1.16
|
0.93 Migraine days by month.
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: Three months previous and three months after the treatment.Population: The intensity of pain was measurable by VAS (visual analogous scale) pre and post-treatment.
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.
Outcome measures
| Measure |
Valproate Group
n=17 Participants
Comparison between the frequency by month in the three months previous to the starting and the following three months with the use of VPA.
|
Memantine
n=16 Participants
Pretreatment the mean was 5.31 (migraine/days) after treatment was 0.92
|
|---|---|---|
|
The Change in the Intensity of the Pain in a Migraine Attack Will be Measured by a Visual Analogue Scale (VAS).
Pre-treatment
|
8.94 Score on a scale
Standard Deviation 0.87
|
8.5 Score on a scale
Standard Deviation 1.36
|
|
The Change in the Intensity of the Pain in a Migraine Attack Will be Measured by a Visual Analogue Scale (VAS).
Post-treatment
|
2.5 Score on a scale
Standard Deviation 0.87
|
4.28 Score on a scale
Standard Deviation 3.65
|
PRIMARY outcome
Timeframe: Three months.Population: MIDAS (Migraine Disability Assessment Score) is a critical evaluation to see the difference between pre and post-treatment with the active drugs we are evaluating.
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.
Outcome measures
| Measure |
Valproate Group
n=17 Participants
Comparison between the frequency by month in the three months previous to the starting and the following three months with the use of VPA.
|
Memantine
n=16 Participants
Pretreatment the mean was 5.31 (migraine/days) after treatment was 0.92
|
|---|---|---|
|
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.
Pre-treatment
|
51.92 score on a scale
Standard Deviation 22.67
|
60.87 score on a scale
Standard Deviation 15.57
|
|
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.
Post-treatment
|
10.53 score on a scale
Standard Deviation 19.97
|
15.57 score on a scale
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: Three monthsPopulation: Individual weight and mean pre and post-treatment with both drugs.
To compare the average weight in both arms before and after Valproate and Memantine administration. The weight will be measured in kilograms, and the initial against the final will be compared.
Outcome measures
| Measure |
Valproate Group
n=17 Participants
Comparison between the frequency by month in the three months previous to the starting and the following three months with the use of VPA.
|
Memantine
n=16 Participants
Pretreatment the mean was 5.31 (migraine/days) after treatment was 0.92
|
|---|---|---|
|
Measure Changes in Weight With the Administration of Active Drugs.
Pre-treatment
|
71.77 kilograms
Standard Deviation 10.3
|
64.44 kilograms
Standard Deviation 5.8
|
|
Measure Changes in Weight With the Administration of Active Drugs.
Post-treatment
|
72.13 kilograms
Standard Deviation 10.5
|
64.19 kilograms
Standard Deviation 5.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Three monthsPopulation: The final analysis was made on a total of 33 participants. However, six left the study because we were in a pandemic situation.
The number of adverse events and the safety of memantine and valproate. Evaluated according to CTCAE v5.0. There were several side effects, but no one had life-threatening or serious side effects.
Outcome measures
| Measure |
Valproate Group
n=17 Participants
Comparison between the frequency by month in the three months previous to the starting and the following three months with the use of VPA.
|
Memantine
n=16 Participants
Pretreatment the mean was 5.31 (migraine/days) after treatment was 0.92
|
|---|---|---|
|
To Compare the Adverse Events in the Use of Memantine in Comparision With Valpoate in the Episodic Migraine Treatment.
Poor concentration
|
0 Participants
|
2 Participants
|
|
To Compare the Adverse Events in the Use of Memantine in Comparision With Valpoate in the Episodic Migraine Treatment.
Dizziness
|
0 Participants
|
2 Participants
|
|
To Compare the Adverse Events in the Use of Memantine in Comparision With Valpoate in the Episodic Migraine Treatment.
No side effects
|
10 Participants
|
8 Participants
|
|
To Compare the Adverse Events in the Use of Memantine in Comparision With Valpoate in the Episodic Migraine Treatment.
Somnolence
|
6 Participants
|
4 Participants
|
|
To Compare the Adverse Events in the Use of Memantine in Comparision With Valpoate in the Episodic Migraine Treatment.
Parasomnia
|
1 Participants
|
0 Participants
|
Adverse Events
Valproate Group
Memantine
Serious adverse events
| Measure |
Valproate Group
n=17 participants at risk
VPA is a well know antiepileptic drug with multiple side effects. However, in low doses are a few side effects problems.
|
Memantine
n=16 participants at risk
Memantine is a tolerable drug. However, it is always necessary to ask for side effects in this type o research.
|
|---|---|---|
|
Infections and infestations
Untoward medical occurrence in the time of study related or not to the drug of the trial
|
11.8%
2/17 • Number of events 2 • Three months of pretreatment (baseline characteristics) Three months, the duration of the study (12 weeks) Three months post-treatment vigilance.
|
6.2%
1/16 • Number of events 1 • Three months of pretreatment (baseline characteristics) Three months, the duration of the study (12 weeks) Three months post-treatment vigilance.
|
Other adverse events
| Measure |
Valproate Group
n=17 participants at risk
VPA is a well know antiepileptic drug with multiple side effects. However, in low doses are a few side effects problems.
|
Memantine
n=16 participants at risk
Memantine is a tolerable drug. However, it is always necessary to ask for side effects in this type o research.
|
|---|---|---|
|
Nervous system disorders
Somnolence
|
35.3%
6/17 • Number of events 6 • Three months of pretreatment (baseline characteristics) Three months, the duration of the study (12 weeks) Three months post-treatment vigilance.
|
25.0%
4/16 • Number of events 4 • Three months of pretreatment (baseline characteristics) Three months, the duration of the study (12 weeks) Three months post-treatment vigilance.
|
|
Nervous system disorders
Lack of concentration
|
0.00%
0/17 • Three months of pretreatment (baseline characteristics) Three months, the duration of the study (12 weeks) Three months post-treatment vigilance.
|
12.5%
2/16 • Number of events 2 • Three months of pretreatment (baseline characteristics) Three months, the duration of the study (12 weeks) Three months post-treatment vigilance.
|
|
Nervous system disorders
Parasomnia
|
5.9%
1/17 • Number of events 1 • Three months of pretreatment (baseline characteristics) Three months, the duration of the study (12 weeks) Three months post-treatment vigilance.
|
0.00%
0/16 • Three months of pretreatment (baseline characteristics) Three months, the duration of the study (12 weeks) Three months post-treatment vigilance.
|
|
Nervous system disorders
dizziness
|
0.00%
0/17 • Three months of pretreatment (baseline characteristics) Three months, the duration of the study (12 weeks) Three months post-treatment vigilance.
|
12.5%
2/16 • Number of events 2 • Three months of pretreatment (baseline characteristics) Three months, the duration of the study (12 weeks) Three months post-treatment vigilance.
|
Additional Information
Ildefonso Rodriguez-Leyva MD, PhD
Medicine Faculty, Universidad Autónoma de San Luis Potosi
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place