CompletedPhase 3

Efficacy, Tolerability, and Safety Study of DFN-15

United States622 participantsStarted 2016-12

Plain-language summary

Efficacy, Tolerability, and Safety of DFN-15 in episodic migraine with or without aura, being conducted at multiple centers in the United States.

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. A history of episodic migraine, who experience 2 to 8 migraine attacks per month for at least the past 12 months, with no more than 14 headache days per month, and with 48 hours of headache-free time between migraine attacks.
✓. Patients who have migraine with or without aura with onset before age 50 years
✓. Report usual migraine pain of 2 (moderate) or 3 (severe) on headache pain severity scale without treatment.
✓. Subjects who are willing and able to:
✓. Evaluate and record pain, migraine symptoms, and study drug effectiveness information in real-time using a subject eDiary for the duration of the study;
✓. Record each instance of the use of study drug and rescue medication in real-time using a subject eDiary for the duration of the study;
✓. Comply with all other study procedures and scheduling requirements.

✕. Minors, even if they are in the specified study age range
✕. Medication overuse:
✕. Opioids greater than or equal to 10 days during the 90 days prior to screening
✕. Combination medications (e.g., Fiorinal®) greater than or equal to 10 days during the 90 days prior to screening (applies only if includes opioid and/or barbiturate)
✕. Nonsteroidal Anti-inflammatory Drugs or other simple medications greater than 14 days a month during the 90 days prior to screening
✕. Triptans or ergots greater than or equal to 10 days a month during the 90 days prior to screening
✕. Treated with onabotulinumtoxin A (Botox®) for migraine within 4 months prior to screening. (If treated for cosmetic reasons, subjects may be included).
✕. Current treatment with antipsychotics or use of antipsychotics within 30 days prior to randomization.

Percentage of Subjects Who Are Pain-free at 2 Hours Postdose (DB1)

Timeframe: 2 hours post dose

Percentage of Subjects Who Are Free From Their MBS at 2 Hours Postdose (DB1)

Timeframe: 2 hours post dose

NCT IDNCT03006276

SponsorBioDelivery Sciences International

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-11

Results submitted2022-04-22

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. A history of episodic migraine, who experience 2 to 8 migraine attacks per month for at least the past 12 months, with no more than 14 headache days per month, and with 48 hours of headache-free time between migraine attacks.
✓. Patients who have migraine with or without aura with onset before age 50 years
✓. Report usual migraine pain of 2 (moderate) or 3 (severe) on headache pain severity scale without treatment.
✓. Subjects who are willing and able to:
✓. Evaluate and record pain, migraine symptoms, and study drug effectiveness information in real-time using a subject eDiary for the duration of the study;
✓. Record each instance of the use of study drug and rescue medication in real-time using a subject eDiary for the duration of the study;
✓. Comply with all other study procedures and scheduling requirements.

✕. Minors, even if they are in the specified study age range
✕. Medication overuse:
✕. Opioids greater than or equal to 10 days during the 90 days prior to screening
✕. Combination medications (e.g., Fiorinal®) greater than or equal to 10 days during the 90 days prior to screening (applies only if includes opioid and/or barbiturate)
✕. Nonsteroidal Anti-inflammatory Drugs or other simple medications greater than 14 days a month during the 90 days prior to screening
✕. Triptans or ergots greater than or equal to 10 days a month during the 90 days prior to screening
✕. Treated with onabotulinumtoxin A (Botox®) for migraine within 4 months prior to screening. (If treated for cosmetic reasons, subjects may be included).
✕. Current treatment with antipsychotics or use of antipsychotics within 30 days prior to randomization.