Trial · NCT07103694
i-NEED: NEw migrainE Drugs Database
NCT07103694, Recruiting, IRCCS San Raffaele Roma
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. i-NEED: NEw migrainE Drugs Database. Trials, record NCT07103694. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07103694
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- i-NEED: NEw migrainE Drugs Database
- NCT number
- NCT07103694
- Status
- Recruiting
- Enrollment
- 2,641 participants, estimated
- Lead sponsor
- IRCCS San Raffaele Roma
- Conditions
- Episodic Migraine, Chronic Migraine, Medication Overuse Headache
- Interventions
- anti-CGRP monoclonal antibodies, gepants, combination of sumatriptan and naproxen, ditan
- First posted
- 2025-08-05
- Last updated
- 2026-06-11
Source ClinicalTrials.gov
Registered outcomes61
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | effectiveness of innovative drugs as migraine prophylaxis | the assessment will be conducted at 4 weeks from treatment initiation | reduction in the number of monthly migraine days compared to the baseline average recorded in the three months preceding treatment |
| Primary | effectiveness of innovative drugs as migraine prophylaxis | the assessment will be conducted at 8 weeks from treatment initiation | reduction in the number of monthly migraine days compared to the baseline average recorded in the three months preceding treatment |
| Primary | effectiveness of innovative drug as migraine prophylaxis | the assessment will be conducted at 12 weeks from treatment initiation | reduction in the number of monthly migraine days compared to the baseline average recorded in the three months preceding treatment |
| Primary | effectiveness of innovative drugs as migraine prophylaxis | the assessment will be conducted at 24 weeks from treatment initiation | reduction in the number of monthly migraine days compared to the baseline average recorded in the three months preceding treatment |
| Primary | effectiveness of innovative drugs as migraine prophylaxis | the assessment will be conducted at 48 weeks from treatment initiation | reduction in the number of monthly migraine days compared to the baseline average recorded in the three months preceding treatment |
| Primary | 2 hour-pain freedom | 2 hours | Percentage of patients reporting complete pain relief within 2 hours after taking the innovative drug for migraine attack |
| Secondary | safety and tolerability of innovative drugs as migraine prophylaxis | the assessment will be conducted at 48 weeks from treatment initiation | type and number of adverse events occurring during the study period (event details, duration, severity and action taken) |
| Secondary | impact of innovative drugs as migraine prophylaxis on symptomatic medication use and medication overuse headache | the assessment will be conducted at 48 weeks from treatment initiation | reduction in the average monthly consumption of analgesics in patients undergoing treatment with innovative drugs |
| Secondary | impact of innovative drugs as migraine prophylaxis on migraine symptoms | the assessment will be conducted at 4 weeks from treatment initiation | mean change in perceived pain intensity during a migraine attack (measured using the Numerical Rating Scale, score range 0-10) compared to the pre-treatment period |
| Secondary | impact of innovative drugs as migraine prophylaxis on migraine symptoms | the assessment will be conducted at 8 weeks from treatment initiation | mean change in perceived pain intensity during a migraine attack (measured using the Numerical Rating Scale, score range 0-10) compared to the pre-treatment period |
1 to 10 of 61Source ClinicalTrials.gov
See all 61 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.
Papers12
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 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/NCT07103694
GET https://conductscience.org/api/trials/v1/NCT07103694/registered?page=2