Multi-Center, Randomized Double-Blind Study to Evaluate the Efficacy and Safety of CAP3 in the Treatment of Acute Migraine

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-003973-10-FI

Enrollment

198

Registered

2005-05-03

Start date

2005-07-21

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute migraine MedDRA version: 7.1 Level: PT Classification code 10027599

Interventions

Product Code: CAP3 Pharmaceutical Form: Nasal spray* INN or Proposed INN: carbon dioxide CAS Number: 124-38-9 Concentration unit: % percent Concentration type: equal Concentration number: 99- Pharmace

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subject has a minimum 12-month migraine history that the investigator determines meets the IHS Migraine Diagnostic Criteria for migraine with or without aura. 2. Subject is between 18-65 years of age. 3. Subject experiences an average of 2-6 migraines per month. 4. If on preventive migraine therapy, medication regimen has been stable for 3 months and will remain stable for the duration of participation. 5. Subject is able to communicate adequately and comply with the requirements of the study as determined by the investigator. 6. Subject is able to read and understand the informed consent and voluntarily agrees to sign the informed consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Subject’s age of migraine onset is greater than 50 years. 2. Subject has more than 10 non-migraine headache days per month. 3. Subject has less than 48 hours of freedom from headache between attacks of migraine. 4. Subject is pregnant or lactating. 5. Subject has history of alcohol or drug abuse within the past 2 years. 6. Subject has existing serious medical condition (i.e., severe emphysema) that precludes participation. 7. Subject participating in another clinical trial during or within 30 days prior to study enrolment. 8. Subject has participated in more than 2 acute migraine attack studies in the 2 years prior to study enrollment.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary study objective is to demonstrate tolerability and efficacy of CAP3 in the treatment of acute migraine of mild, moderate or severe intensity. ;Secondary Objective: 1. Pain-free status at 15, 30, 45, 60 minutes and 4 and 24 hours post first dose administration, 2. Sustained pain-free response between 2 and 24 hours (freedom of pain at 2 hrs with no rescue medication and with no headache recurrence within 24 hrs), 3. Pain relief at 2 hrs (defined as a decrease in headache pain intensity from severe or moderate headache pain at baseline to mild or no pain at 2 hrs), (only for moderate/ severe at entry), 4. Early treatment pain improvement at 2 hours (defined as decrease in headache pain intensity from severe or moderate to mild or no pain or decrease from mild to no pain at 2 hours) for all migraines treated within 2 hours of onset. 5. Relief of associated symptoms such as nausea, and photophobia and phonophobia at 2 hours, 6. Safety and tolerability of study drug, 7. Subject treatment satisfaction, 8. Use of rescue medication, 9. Functional disability. 10. Consistency of response in at least 2 of 3 attacks. ;Primary end point(s): There are two primary endpoints: · Percentage of migraine attacks who reached the status of pain-free at 2 hours post first administration of CAP3 for all migraine attacks · Percentage of patients who are pain-free at 2 hours post first administration of CAP3 after the first migraine attack	—

Measure

Time frame

Main Objective: The primary study objective is to demonstrate tolerability and efficacy of CAP3 in the treatment of acute migraine of mild, moderate or severe intensity. ;Secondary Objective: 1. Pain-free status at 15, 30, 45, 60 minutes and 4 and 24 hours post first dose administration, 2. Sustained pain-free response between 2 and 24 hours (freedom of pain at 2 hrs with no rescue medication and with no headache recurrence within 24 hrs), 3. Pain relief at 2 hrs (defined as a decrease in headache pain intensity from severe or moderate headache pain at baseline to mild or no pain at 2 hrs), (only for moderate/ severe at entry), 4. Early treatment pain improvement at 2 hours (defined as decrease in headache pain intensity from severe or moderate to mild or no pain or decrease from mild to no pain at 2 hours) for all migraines treated within 2 hours of onset. 5. Relief of associated symptoms such as nausea, and photophobia and phonophobia at 2 hours, 6. Safety and tolerability of study drug, 7. Subject treatment satisfaction, 8. Use of rescue medication, 9. Functional disability. 10. Consistency of response in at least 2 of 3 attacks. ;Primary end point(s): There are two primary endpoints: · Percentage of migraine attacks who reached the status of pain-free at 2 hours post first administration of CAP3 for all migraine attacks · Percentage of patients who are pain-free at 2 hours post first administration of CAP3 after the first migraine attack

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Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026