Trial · NCT05685225
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of subjects with acute migraine who achieved freedom from pain after dosing | 2 hours after dosing | Freedom from pain is defined as the absence of headache pain from moderate or severe pain at baseline, without the use of rescue medication. The pain is measured on a 4-point scale, with 0 indicating no pain, 1 for mild pain, 2 for moderate pain, and 3 for severe pain. |
| Primary | Proportion of subjects with acute migraine who achieved freedom from migraine's Most Bothersome Symptoms (MBS) after dosing | 2 hours after dosing | MBS freedom is defined as the absence of the identified Most Bothersome Symptom (MBS), which can be nausea, photophobia, or phonophobia. The MBS is measured on a binary scale, either absent or present. |
| Secondary | Proportion of subjects with acute migraine who achieved pain relief | 2 hours after dosing | Pain relief is defined as a reduction in headache pain severity from moderate or severe to mild or no headache pain. |
| Secondary | Proportion of subjects with acute migraine who achieved freedom from photophobia | 2 hours after dosing | Freedom from photophobia is defined as absence of photophobia |
| Secondary | Proportion of subjects with acute migraine who achieved freedom from phonophobia | 2 hours after dosing | Freedom from phonophobia is defined as absence of phonophobia |
| Secondary | Proportion of subjects with acute migraine who achieved freedom from nausea | 2 hours after dosing | Freedom from nausea is defined as absence of nausea |
| Secondary | Proportion of subjects with acute migraine who achieved sustained pain relief from 2 to 24 hours | 2 to 24 hours | Sustained pain relief is defined as the reduction of headache pain severity from moderate or severe intensity to mild without the use of rescue medication. |
| Secondary | The proportion of subjects with acute migraine who achieved sustained pain freedom from 2 to 24 hours | 2 to 24 hours | Sustained pain freedom is defined as the absence of any headache pain of any intensity without the use of rescue medication. |
| Secondary | Functional disability at 2 hours | 2 hours after dosing | Functional disability refers to the inability to perform activities of daily living or work tasks to a normal level due to physical, mental, or sensory impairments. It is measured on a scale of 0 to 3, where 0 indicates normal function and 3 indicates the need for bedrest due to severe impairment. |
| Secondary | Functional disability at 24 hours | 24 hours after dosing | Functional disability refers to the inability to perform activities of daily living or work tasks to a normal level due to physical, mental, or sensory impairments. It is measured on a scale of 0 to 3, where 0 indicates normal function and 3 indicates the need for bedrest due to severe impairment. |
| Secondary | Use of rescue medications within 24 hours | within 24 hours | Rescue medication use refers to the use of an additional medication to treat the current migraine. |
| Secondary | Pain relapse within 48 hours | within 48 hours | Pain relapse refers to the reappearance of headache pain of any severity when the subject had been free of pain 2 hours after dosing. |
| Other | Hamilton Anxiety Rating Scale score | Baseline (Randomization Visit) to 2 hours after dosing | The Hamilton Anxiety Rating Scale is a validated assessment tool for measuring anxiety symptoms. The scale consists of fourteen items designed to assess the severity of anxiety on a scale of zero to four, with four being the most severe. |
| Other | Hamilton Anxiety Rating Scale score | Baseline (Randomization Visit) to 24 hours after dosing | The Hamilton Anxiety Rating Scale is a validated assessment tool for measuring anxiety symptoms. The scale consists of fourteen items designed to assess the severity of anxiety on a scale of zero to four, with four being the most severe. |
| Other | Self-reported overall sense of wellbeing | 2 hours after dosing | Self-reported overall sense of wellbeing (physical and emotional) is a subjective measurement that reflects an individual's perception of their physical and emotional health. It is typically assessed on a 4-point scale, ranging from 0 (Poor) to 3 (Superb), with 1 (Okay) and 2 (Good) representing intermediate levels of wellbeing. This measurement considers factors such as physical pain, positive emotions, life satisfaction, stress management, and the absence of negative emotions like depression and anxiety. |
| Other | Self-reported hurt feelings score | 2 hours after dosing | Self-reported hurt feelings on a 4-point scale: (0=Not at all, 1=Slightly, 2=Moderate, 3=Extremely). |
| Other | Self-reported tense feelings score | 2 hours after dosing | Self-reported tense feelings on a 4-point scale: (0=Not at all, 1=Slightly, 2=Moderate, 3=Extremely). |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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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