Trial · NCT04698525
Comparative Study Between Valproate and Memantine in the Prophylactic Management of Episodic Migraine.
NCT04698525, Phase 3, Completed, Universidad Autonoma de San Luis Potosí; results first posted 2023-05-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparative Study Between Valproate and Memantine in the Prophylactic Management of Episodic Migraine. Trials, record NCT04698525. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04698525
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparative Study Between Valproate and Memantine in the Prophylactic Management of Episodic Migraine.
- NCT number
- NCT04698525
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 33 participants, actual
- Lead sponsor
- Universidad Autonoma de San Luis Potosí
- Conditions
- Migraine Headache
- Interventions
- Valproate Sodium, Memantine
- First posted
- 2021-01-07
- Last updated
- 2024-05-09
- Results first posted
- 2023-05-17
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Reduction in Days of Headache Pain With Treatment of Memantine or Valproate in the Preventive Management of Episodic Migraine. | Three months before treatment (Pretreatment), three months after initiating treatment (post-treatment) | 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. |
| Primary | The Change in the Intensity of the Pain in a Migraine Attack Will be Measured by a Visual Analogue Scale (VAS). | Three months previous and three months after the 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. |
| Primary | 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. | Three months. | 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. |
| Secondary | Measure Changes in Weight With the Administration of Active Drugs. | Three months | 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. |
| Other | To Compare the Adverse Events in the Use of Memantine in Comparision With Valpoate in the Episodic Migraine Treatment. | Three months | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Reduction in Days of Headache Pain With Treatment of Memantine or Valproate in the Preventive Management of Episodic Migraine. | Three months before treatment (Pretreatment), three months after initiating treatment (post-treatment) | It was a straightforward difference between pre and post-treatment in both groups. | Migraine days by month. | MEAN |
| PRIMARY | The Change in the Intensity of the Pain in a Migraine Attack Will be Measured by a Visual Analogue Scale (VAS). | Three months previous and three months after the treatment. | The intensity of pain was measurable by VAS (visual analogous scale) pre and post-treatment. | Score on a scale | MEAN |
| PRIMARY | 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. | Three months. | 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. | score on a scale | MEAN |
| SECONDARY | Measure Changes in Weight With the Administration of Active Drugs. | Three months | Individual weight and mean pre and post-treatment with both drugs. | kilograms | MEAN |
| OTHER_PRE_SPECIFIED | To Compare the Adverse Events in the Use of Memantine in Comparision With Valpoate in the Episodic Migraine Treatment. | Three months | The final analysis was made on a total of 33 participants. However, six left the study because we were in a pandemic situation. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Reduction in Days of Headache Pain With Treatment of Memantine or Valproate in the Preventive Management of Episodic Migraine. | Valproate Group | Pretreatment | 5.35 | Standard Deviation 1.11 | Migraine days by month. |
| Reduction in Days of Headache Pain With Treatment of Memantine or Valproate in the Preventive Management of Episodic Migraine. | Memantine | Pretreatment | 5.31 | Standard Deviation 1.5 | Migraine days by month. |
| Reduction in Days of Headache Pain With Treatment of Memantine or Valproate in the Preventive Management of Episodic Migraine. | Valproate Group | Post-treatment | 0.77 | Standard Deviation 1.16 | Migraine days by month. |
| Reduction in Days of Headache Pain With Treatment of Memantine or Valproate in the Preventive Management of Episodic Migraine. | Memantine | Post-treatment | 0.93 | Standard Deviation 1.4 | Migraine days by month. |
| The Change in the Intensity of the Pain in a Migraine Attack Will be Measured by a Visual Analogue Scale (VAS). | Valproate Group | Pre-treatment | 8.94 | Standard Deviation 0.87 | Score on a scale |
| The Change in the Intensity of the Pain in a Migraine Attack Will be Measured by a Visual Analogue Scale (VAS). | Memantine | Pre-treatment | 8.5 | Standard Deviation 1.36 | Score on a scale |
| The Change in the Intensity of the Pain in a Migraine Attack Will be Measured by a Visual Analogue Scale (VAS). | Valproate Group | Post-treatment | 2.5 | Standard Deviation 0.87 | Score on a scale |
| The Change in the Intensity of the Pain in a Migraine Attack Will be Measured by a Visual Analogue Scale (VAS). | Memantine | Post-treatment | 4.28 | Standard Deviation 3.65 | Score on a scale |
| 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. | Valproate Group | Pre-treatment | 51.92 | Standard Deviation 22.67 | score on a scale |
| 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. | Memantine | Pre-treatment | 60.87 | Standard Deviation 15.57 | score on a scale |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Valproate Group | 17 | |
| Overall Study | STARTED | Memantine | 16 | |
| Overall Study | COMPLETED | Valproate Group | 14 | |
| Overall Study | COMPLETED | Memantine | 13 | |
| Overall Study | NOT COMPLETED | Valproate Group | 3 | |
| Overall Study | NOT COMPLETED | Memantine | 3 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Somnolence | Nervous system disorders | Valproate Group | 6 | 17 | 6 |
| other | Somnolence | Nervous system disorders | Memantine | 4 | 16 | 4 |
| other | Lack of concentration | Nervous system disorders | Valproate Group | 0 | 17 | 0 |
| other | Lack of concentration | Nervous system disorders | Memantine | 2 | 16 | 2 |
| other | Parasomnia | Nervous system disorders | Valproate Group | 1 | 17 | 1 |
| other | Parasomnia | Nervous system disorders | Memantine | 0 | 16 | 0 |
| other | dizziness | Nervous system disorders | Valproate Group | 0 | 17 | 0 |
| other | dizziness | Nervous system disorders | Memantine | 2 | 16 | 2 |
| serious | Untoward medical occurrence in the time of study related or not to the drug of the trial | Infections and infestations | Valproate Group | 2 | 17 | 2 |
| serious | Untoward medical occurrence in the time of study related or not to the drug of the trial | Infections and infestations | Memantine | 1 | 16 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Valproate Group | 0 | 17 |
| Total, all-cause mortality | Memantine | 0 | 16 |
| Total, other adverse events | Valproate Group | 7 | 17 |
| Total, other adverse events | Memantine | 8 | 16 |
| Total, serious adverse events | Valproate Group | 2 | 17 |
| Total, serious adverse events | Memantine | 1 | 16 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Valproate Group vs Memantine: deaths from any cause | Trial comparisons |
| Valproate Group vs Memantine: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04698525
GET https://conductscience.org/api/trials/v1/NCT04698525/results?page=2