Study to Determine Safety and Efficacy of B244 in Subjects With Episodic Migraine
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03488563|
Recruitment Status : Completed
First Posted : April 5, 2018
Last Update Posted : August 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Biological: B244 Biological: Vehicle||Phase 2|
This is a Prospective, Randomized, Vehicle‐controlled, Double‐blind, Multi-center, 3-arm study assessing the safety, tolerability, and efficacy of B244 delivered as an intranasal spray for preventive treatment in subjects with episodic migraine.
At Screening and Baseline, all subjects must experiences 4-14 migraine days per month and 3-14 migraine attacks per month and no more than 14 headache days per month in the 3 months prior to screening.
The total duration of the study will be approximately 16 weeks. Participants will report for a Screening visit and if all inclusion criteria are met, subjects will go through a one month baseline period prior to randomization. Subjects will come in for visits at Day 28 (Week 4), Day 56 (Week8), Day 84 (Week12), and Day 112 (Week 16).
Efficacy will be assessed by change in migraine attacks, days, and hours. Blood and urine samples will be collected for standard safety laboratory testing and the effect of the drug on inflammatory biomarkers. Safety will be monitored throughout the study.
Investigators plan to enroll 303 total subjects. Subjects will be randomized 1:1:1 so that an equal number of subjects will be treated in each arm of the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||314 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomization will be 1:1:1 so that equal number of subjects will be treated in each arm of the study.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Each participant scheduled to receive investigational product (IP) will receive a randomization number at the time of randomization. The randomization number will be used to identify the study medication kit assigned to the participant and indicate the treatment to be administered to that participant.|
|Official Title:||A Prospective, Randomized, Vehicle-Controlled, Double-Blind, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of B244 Delivered as an Intranasal Spray for Preventive Treatment in Subjects With Episodic Migraine|
|Actual Study Start Date :||March 30, 2018|
|Actual Primary Completion Date :||June 17, 2019|
|Actual Study Completion Date :||July 16, 2019|
Experimental: B244 Dose 1
B244 1X suspension in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day
Experimental: B244 Dose 2
B244 4X suspension in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day
Placebo Comparator: Vehicle
Vehicle, 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Baseline to Day 112 ]Safety and tolerability endpoints will consist of all adverse events reporting during the study duration.
- Mean change in monthly migraine days. [ Time Frame: Baseline to Day 84 ]
- Mean change in monthly migraine attacks. [ Time Frame: Baseline to Day 84 ]
- Proportion of subjects experiencing a 50%, 75%, and 100% reduction in monthly migraine days. [ Time Frame: Baseline to Day 112 ]
- Mean change in monthly acute migraine specific medication days. [ Time Frame: Baseline to Day 84 ]
- Mean change from baseline to 12 weeks of treatment in disability, as measured by the Migraine Disability Assessment (MIDAS) [ Time Frame: Baseline to Day 84 ]
- Mean change from baseline to 12 weeks of treatment in monthly Headache Impact Test-6 (HIT-6) questionnaire [ Time Frame: Baseline to Day 84 ]
- Mean change from baseline to 12 weeks of treatment in monthly Migraine Specific Quality of Life questionnaire (MSQL) [ Time Frame: Baseline to Day 84 ]
- Mean change in subject recorded migraine associated symptoms: nausea/vomiting, photophobia and sonophobia. [ Time Frame: Baseline to Day 112 ]Self reported subject diary
- Difference in plasma immune biomarker levels between active and vehicle groups [ Time Frame: Baseline to Day 112 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03488563
|Study Director:||Judith Ng-Cashin, MD||Chief Medical Officer|