Efficacy, Tolerability, and Safety Study of DFN-15

BioDelivery Sciences International

Status and phase: Completed; Phase 3

Conditions: Migraine Headache

Treatments: Other: DFN-15 Placebo; Drug: DFN-15 Active

Study type: Interventional

Funder types: Industry

Identifiers

NCT03006276

DFN-15-CD-007

Details and patient eligibility

About

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

Enrollment: 622 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.

2. Patients who have migraine with or without aura with onset before age 50 years

3. Report usual migraine pain of 2 (moderate) or 3 (severe) on headache pain severity scale without treatment.

4. Subjects who are willing and able to:

   1. Evaluate and record pain, migraine symptoms, and study drug effectiveness information in real-time using a subject eDiary for the duration of the study;
   2. 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;
   3. Comply with all other study procedures and scheduling requirements.

Exclusion criteria

1. Minors, even if they are in the specified study age range

2. Medication overuse:

   1. Opioids greater than or equal to 10 days during the 90 days prior to screening
   2. 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)
   3. Nonsteroidal Anti-inflammatory Drugs or other simple medications greater than 14 days a month during the 90 days prior to screening
   4. Triptans or ergots greater than or equal to 10 days a month during the 90 days prior to screening

3. Treated with onabotulinumtoxin A (Botox®) for migraine within 4 months prior to screening. (If treated for cosmetic reasons, subjects may be included).

4. Current treatment with antipsychotics or use of antipsychotics within 30 days prior to randomization.

5. Patients who have received treatment with an investigational drug or device within 30 days of randomization, or participated in a central nervous system clinical trial within 2 months prior to randomization

6. Patients with positive screening test for human immunodeficiency virus [HIV], positive hepatitis B surface antigen (HBsAg), or positive hepatitis C virus [HCV] antibody

7. Subjects who are employees or immediate relatives of the employees of the Sponsor, any of its affiliates or partners, or of the clinical research study site.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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622 participants in 2 patient groups, including a placebo group

DFN-15 Active

Experimental group

Description:

DFN-15 Active

Treatment:

Drug: DFN-15 Active

DFN-15 Placebo

Placebo Comparator group

Description:

DFN-15 Placebo

Treatment:

Other: DFN-15 Placebo