Trial · NCT07497854
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To evaluate the safety of NURTEC® ODT 75 mg (Rimegepant sulfate) in adult patients with acute treatment of migraine with or without aura and with preventive treatment of episodic migraine. | 28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate) | All adverse events (AEs) Unit of Measure: Number of participants with AEs |
| Primary | To evaluate the safety of NURTEC® ODT 75 mg (Rimegepant sulfate) in adult patients with acute treatment of migraine with or without aura and with preventive treatment of episodic migraine. | 28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate) | Serious Adverse Events (SAEs) Unit of Measure : Number of participants with SAEs |
| Primary | To evaluate the safety of NURTEC® ODT 75 mg (Rimegepant sulfate) in adult patients with acute treatment of migraine with or without aura and with preventive treatment of episodic migraine. | 28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate) | Expected Adverse Events (Expected AEs) Unit of Measure : Number of participants with Expected AEs |
| Primary | To evaluate the safety of NURTEC® ODT 75 mg (Rimegepant sulfate) in adult patients with acute treatment of migraine with or without aura and with preventive treatment of episodic migraine. | 28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate) | Adverse Drug Reactions (ADRs) Unit of Measure : Number of participants with ADRs |
| Primary | To evaluate the safety of NURTEC® ODT 75 mg (Rimegepant sulfate) in adult patients with acute treatment of migraine with or without aura and with preventive treatment of episodic migraine. | 28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate) | Serious Adverse Drug Reactions (SADRs) Unit of Measure : Number of participants with SADRs |
| Primary | To evaluate the safety of NURTEC® ODT 75 mg (Rimegepant sulfate) in adult patients with acute treatment of migraine with or without aura and with preventive treatment of episodic migraine. | 28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate) | Unexpected Adverse Events (Unexpected AEs) Unit of Measure : Number of participants with Unexpected AEs |
| Primary | To evaluate the safety of NURTEC® ODT 75 mg (Rimegepant sulfate) in adult patients with acute treatment of migraine with or without aura and with preventive treatment of episodic migraine. | 28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate) | Expected Adverse Drug Reactions (Expected ADRs) Unit of Measure : Number of participants with Expected ADRs |
| Primary | To evaluate the safety of NURTEC® ODT 75 mg (Rimegepant sulfate) in adult patients with acute treatment of migraine with or without aura and with preventive treatment of episodic migraine. | 28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate) | Unexpected Adverse Drug Reactions (Unexpected ADRs) Unit of Measure : Number of participants with Unexpected ADRs |
| Secondary | Acute Treatment Effectiveness : Pain Free at 2 Hours | 2 hours post-dose | Percentage of subjects who are pain-free at 2 hours post-dose for the treatment of an acute migraine attack. Unit of Measure: Percentage of participants (%) |
| Secondary | Preventive Treatment Effectiveness : Change in Monthly Migraine Days (MMDs) | Baseline, 3 months, 6 months | Mean change from baseline in the number of Monthly Migraine Days (MMDs). Unit of Measure: Days |
| Secondary | Preventive Treatment Effectiveness : Responder Rate (≥ 50% & ≥ 75%) | 3 months, 6 months | Percentage of subjects who achieve a ≥50% \& ≥ 75% reduction from baseline in MMDs. Unit of Measure: Percentage of participants (%) |
| Secondary | Preventive Treatment Effectiveness : MIDAS (Migraine Disability Assessment) | 3 months, 6 months | Total score of the MIDAS questionnaire to assess headache-related disability. Unit of Measure: Score (points) |
| Secondary | Preventive Treatment Effectiveness : HIT-6 (Headache Impact Test-6) | 3 months, 6 months | Total score of the HIT-6 questionnaire to measure the impact of headaches on daily life. Unit of Measure: Score (points |
| Secondary | Acute & Preventive Treatment Effectiveness | 24 weeks (at the completion of follow-up or at the time of treatment discontinuation/withdrawal) | The percentage of subjects categorized as 'Improved' based on the investigator's clinical judgment and/or laboratory test results. Overall effectiveness is evaluated across four categories (Improved, Unchanged, Aggravated, Not assessed), with 'Improved' cases being used to calculate the final effectiveness rate. * Improved: Symptoms are deemed to be improved or maintained (including cases where the effect of a previous drug is maintained after switching to NURTEC® ODT). * Unchanged: Symptoms show no improvement compared to baseline, nor is there a maintenance effect. * Aggravated: Symptoms have worsened compared to baseline. * Not assessed: Effectiveness results are not available. Unit of Measure: Percentage of participants (%) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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