Trial Outcomes & Findings for Occipital Nerve Stimulation (ONS) for Migraine: OPTIMISE (NCT NCT01775735)

Last Updated: 2020-11-13

Results Overview

A moderate-to-severe headache day will be defined as any calendar day with: 1. headache pain that lasts ≥4 hours AND peak severity of moderate or severe intensity OR 2. a subject taking a triptan or ergot, regardless of headache pain duration or severity The Baseline number was calculated as the total count of eDiary calendar days which meet the definition of a moderate-to-severe headache day during the first 30 calendar days of eDiary entries if the eDiary contained ≥70% of data. The 6 months post-randomization number was calculated as the total count of eDiary calendar days which meet the definition of a moderate-to-severe headache day during the 30 calendar days of eDiary entries immediately preceding the subject's 6-Month Visit if the eDiary contained ≥70% of data.

Recruitment status

TERMINATED

Study phase

Target enrollment

28 participants

Primary outcome timeframe

from Baseline to 6 months post-randomization

Results posted on

2020-11-13

Participant Flow

28 subjects were consented in the study. 13 failed screening and 15 were randomized. Statistically relevant conclusions cannot be made from this small sample size.

Participant milestones

Participant milestones
Measure	Treatment The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve	Control The control is intermittent stimulation for 20 seconds every 90 minutes with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve
Intervention (6 Months) STARTED	8	7
Intervention (6 Months) COMPLETED	8	7
Intervention (6 Months) NOT COMPLETED	0	0
Open Label (24 Months) STARTED	8	7
Open Label (24 Months) COMPLETED	7	3
Open Label (24 Months) NOT COMPLETED	1	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Occipital Nerve Stimulation (ONS) for Migraine: OPTIMISE

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=8 Participants The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precision™ ONS System Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve	Control n=7 Participants The control is intermittent stimulation for 20 seconds every 90 minutes with an occipital nerve stimulator, specifically the BSC Precision™ ONS System Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve	Total n=15 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=93 Participants	7 Participants n=4 Participants	14 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	7 Participants n=4 Participants	15 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Race/Ethnicity · American Indian or Alaska native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic or Latino	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Race/Ethnicity · Native Hawaiian or other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	7 Participants n=93 Participants	7 Participants n=4 Participants	14 Participants n=27 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	8 participants n=93 Participants	7 participants n=4 Participants	15 participants n=27 Participants

PRIMARY outcome

Timeframe: from Baseline to 6 months post-randomization

Population: All subjects who completed Baseline and 6 months post-randomization and had ≥70% of eDiary data. Data for 5 subjects was not calculated due to missing eDiary data. Statistical analysis was not performed as the sample size is too small to draw any statistically relevant conclusions.

Outcome measures

Outcome measures
Measure	Treatment n=4 Participants The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve	Control n=6 Participants The control is intermittent stimulation for 20 seconds every 90 minutes with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve
Change in the Number of Moderate-to-severe Headache Days Per Month	-5.2 days Standard Deviation 7.3	0 days Standard Deviation 10.8

Adverse Events

Treatment

Serious events: 4 serious events

Other events: 3 other events

Deaths: 0 deaths

Control

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment n=8 participants at risk The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve	Control n=7 participants at risk The control is intermittent stimulation for 20 seconds every 90 minutes with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve
Nervous system disorders Migraine	12.5% 1/8 • Number of events 12 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.	0.00% 0/7 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.
Nervous system disorders Status migrainosus	25.0% 2/8 • Number of events 2 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.	0.00% 0/7 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.
Nervous system disorders Hemiplegic migraine	12.5% 1/8 • Number of events 1 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.	0.00% 0/7 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.
Nervous system disorders Migraine without aura	12.5% 1/8 • Number of events 1 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.	0.00% 0/7 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.
General disorders Adverse drug reaction	25.0% 2/8 • Number of events 2 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.	0.00% 0/7 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.
Infections and infestations Cellulitis	12.5% 1/8 • Number of events 2 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.	0.00% 0/7 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.
Injury, poisoning and procedural complications Wound dehiscence	12.5% 1/8 • Number of events 1 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.	0.00% 0/7 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.
Renal and urinary disorders Nephrolithiasis	12.5% 1/8 • Number of events 1 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.	0.00% 0/7 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.
Vascular disorders Thrombosis	0.00% 0/8 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.	14.3% 1/7 • Number of events 1 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.
Infections and infestations Device related infection	12.5% 1/8 • Number of events 1 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.	0.00% 0/7 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.

Other adverse events

Additional Information

Director, Clinical Sciences and Scientific Communication

Boston Scientific

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Treatment n=8 participants at risk The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve	Control n=7 participants at risk The control is intermittent stimulation for 20 seconds every 90 minutes with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve
General disorders Implant site irritation	12.5% 1/8 • Number of events 1 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.	14.3% 1/7 • Number of events 1 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.
Nervous system disorders Migraine	0.00% 0/8 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.	14.3% 1/7 • Number of events 1 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/8 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.	14.3% 1/7 • Number of events 1 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.
General disorders Impaired healing	0.00% 0/8 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.	14.3% 1/7 • Number of events 1 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.
Infections and infestations Diverticulitis	0.00% 0/8 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.	14.3% 1/7 • Number of events 1 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.
Infections and infestations Pneumonia	12.5% 1/8 • Number of events 1 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.	0.00% 0/7 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.
Infections and infestations Upper respiratory tract infection	12.5% 1/8 • Number of events 1 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.	0.00% 0/7 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.
Injury, poisoning and procedural complications Surgical skin tear	12.5% 1/8 • Number of events 1 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.	0.00% 0/7 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.
Injury, poisoning and procedural complications Suture related complication	12.5% 1/8 • Number of events 1 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.	0.00% 0/7 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.
Musculoskeletal and connective tissue disorders Myofascial pain syndrome	0.00% 0/8 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.	14.3% 1/7 • Number of events 1 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/8 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.	14.3% 1/7 • Number of events 1 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.
Renal and urinary disorders Renal failure acute	12.5% 1/8 • Number of events 1 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.	0.00% 0/7 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.
Vascular disorders Hypotension	12.5% 1/8 • Number of events 1 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.	0.00% 0/7 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.
Immune system disorders Drug hypersensitivity	12.5% 1/8 • Number of events 1 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.	0.00% 0/7 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.
Investigations Body temperature increased	12.5% 1/8 • Number of events 1 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.	0.00% 0/7 • Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.