Trial · NCT02582996
Cefalium® Compared to Tylenol® in the Treatment of Migraine Attacks
NCT02582996, Phase 3, Suspended, Ache Laboratorios Farmaceuticos S.A.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cefalium® Compared to Tylenol® in the Treatment of Migraine Attacks. Trials, record NCT02582996. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02582996
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cefalium® Compared to Tylenol® in the Treatment of Migraine Attacks
- NCT number
- NCT02582996
- Status
- Suspended
- Phases
- Phase 3
- Enrollment
- 336 participants, estimated
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Conditions
- Migraine
- Interventions
- Acetaminophen+Caffeine+Dihydroergotamine+Metoclopramide., Acetaminophen
- First posted
- 2015-10-21
- Last updated
- 2019-04-10
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain relief of Cefalium® compared to Tylenol® | 2 hours | Relief of pain 2 hours after taking medication, being considered to reduce the intensity from strong(3) or moderate(2), at baseline, to mild(1) or absent(0) 2 hours after taking the medication, according to the functional and behavioral debilitating categorical scale without use of rescue medication as annotations the diary of symptoms |
| Secondary | Pain decrease after use of investigational product, without a rescue medication | Up to 4 hours | Number of participants with pain decrease in 2 hours and 4 hours after the use of the investigational product,at the first migraine attack with mild or moderate pain, with remission defined as no pain (0) in categorical scale debilitating functional and behavioral (4 point-scale), without use of a rescue medication |
| Secondary | Pain decrease after use of the investigational product, without a rescue medication | 4 hours | Number of participants with pain relief in 4 hours after the use of the investigational product, in the first migraine attack with mild or moderate pain,and is considered the relief reduction of at least 01 point in pain intensity from baseline, according to functional and behavioral debilitating categorical scale without use of a rescue medication; |
| Secondary | Pain relief maintenance during the period 4-24 hours after use of investigational product | Up to 24 hours | The maintenance will be observed if the relief reached the first 4 hours will remain at 24 hours after use of the investigational product, according to functional and behavioral debilitating categorical scale (4 point scale) without use of rescue medication during this period; |
| Secondary | Nausea/vomiting Symptoms Free | Up to 4 hours | Participants free of nausea/vomiting symptoms 2 and 4 hours after use of investigational product,at the first migraine attack of moderate to severe pain intensity, defined as the proportion of subjects with no symptoms of both among the participants have at least one symptom at baseline of migraine without use of a rescue medication during this period. |
| Secondary | Photophobia/Phonophobia Symptoms Free | Up to 4 hours | Participants free of photophobia/phonophobia symptoms 2 and 4 hours after use of investigational product, at the first migraine attack of moderate to severe pain intensity, defined as the proportion of subjects with no symptoms of both among the participants have at least one symptom at baseline of migraine without use of a rescue medication during this period. |
| Secondary | Need of a rescue medication | Up to 24 hours | Number of participants who use at least once the rescue medication in a 2-24 hours period after use of the investigational product. |
| Other | Variation in laboratory exams ratings | From baseline visit until 30 days after the end of the treatment | Number of participants with any relevant variation in laboratory exams from baseline visit until 30 days after the end of the treatment |
| Other | Variation in clinical exams ratings | From baseline visit until 30 days after the end of the treatment | Number of participants with any relevant variation in clinical exams from baseline visit until 30 days after the end of the treatment |
| Other | Variation in physical exams ratings | From baseline visit until 30 days after the end of the treatment | Number of participants with any relevant variation in physical exams from baseline visit until 30 days after the end of the treatment |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02582996
GET https://conductscience.org/api/trials/v1/NCT02582996/registered