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Inability to supply and maintain treatment device. No safety concerns occurred.
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This study will assess the efficacy of a neuromodulation device for the treatment of episodic migraine headache.
This study is a multi-center, triple-blinded, placebo-controlled, randomized clinical trial for adjunctive prophylactic treatment of episodic migraine headache (with or without aura) using neuromodulation device developed by Scion NeuroStim, LLC (SNS). The investigational use of the device for episodic migraine headache has been reviewed by the FDA and is classified as NSR (non-significant risk).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active | Active Comparator | active neuromodulation |
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| placebo | Placebo Comparator | placebo neuromodulation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active neuromodulation for episodic migraine headache | Device | Non-invasive brainstem neuromodulator. Active and placebo devices appear identical |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Migraine Headache Days (MHD) | comparison of MHD recorded in baseline month versus 3rd month of treatment | 1 month of baseline recordation followed by 84 days of device use |
| Measure | Description | Time Frame |
|---|---|---|
| Normalized Reduction in Migraine Headache Days | comparison of MHD recorded in baseline month versus 3rd month of treatment: percentages, active versus placebo | 1 month of baseline recordation followed by 84 days of device use |
| Change in Medication Usage |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | 85259 | United States | ||
| Neurology Research Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | BID Placebo | Participants self-administered twice-daily inactive/sham treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period). |
| FG001 | BID Active |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 9, 2016 |
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| placebo neuromodulation for episodic migraine headache | Device | Sham non-invasive brainstem neuromodulator. Active and placebo devices appear identical |
|
reduction in acute, prescribed medications in month 3 of treatment versus baseline month |
| 1 month of baseline recordation followed by 84 days of device use |
| Change in Headache Pain | reduction in subject perceived headache pain scores in month 3 of treatment versus baseline month | 1 month of baseline recordation followed by 84 days of device use |
| Change in Quality of Life | comparison of HIT-6 (headache impact test) scores between baseline month and treatment month 3 | 1 month of baseline recordation followed by 84 days of device use |
| Change in Depression | comparison of BDI-II (Beck depression index) scores between baseline month and treatment month 3 | 1 month of baseline recordation followed by 84 days of device use |
| Change in Anxiety | comparison of BAI (Beck anxiety index) scores between baseline month and treatment month 3 | 1 month of baseline recordation followed by 84 days of device use |
| Change in Sleep Quality | comparison of Pittsburgh Sleep assessment scores between baseline month and treatment month 3 | 1 month of baseline recordation followed by 84 days of device use |
| Additional Treatment Time | comparison of MHD recorded in baseline month versus 6th month of treatment | 1 month of baseline recordation followed by 168 days of device use |
| Sustained Reduction in Migraine Headache Days | comparison of MHD recorded in baseline month versus post-treatment months 7, 8 and 9 | 1 month of baseline recordation followed by 252 days of device use |
| West Palm Beach |
| Florida |
| 33407 |
| United States |
| Diamond Headache Clinic | Chicago | Illinois | 60642 | United States |
| Michigan Headache Pain & Neurological Inst. | Ann Arbor | Michigan | 48104 | United States |
| Study Metrix Research | City of Saint Peters | Missouri | 63303 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Jefferson Headache Center | Philadelphia | Pennsylvania | 19107 | United States |
| King's College London | London | Denmark Hill | SE5 9PJ | United Kingdom |
| University of Kent | Canterbury | Kent | CT2 7NP | United Kingdom |
Participants self-administered twice-daily active treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period). |
| FG002 | QD Active | Participants self-administered once-daily active treatments for 12 weeks (treatment period 1) followed by once-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period). |
| COMPLETED |
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| NOT COMPLETED |
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| Treatment Period 2 |
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| Post-treatment Observation Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | BID Placebo | Participants self-administered twice-daily inactive/sham treatments for 12 weeks followed by twice-daily active treatments for 12 weeks followed by a post-treatment observation period lasting 12 months. |
| BG001 | BID Active | Participants self-administered twice-daily treatments for 12 weeks followed by twice-daily active treatments for an additional 12 weeks followed by a post-treatment observation period lasting 12 months. |
| BG002 | QD Active | Participants self-administered once-daily treatments for 12 weeks followed by once-daily active treatments for an additional 12 weeks followed by a post-treatment observation period lasting 12 months. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Monthly migraine days | Monthly migraine days within the 28 day baseline according to an electronic daily diary. | Mean | Standard Deviation | days |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Migraine Headache Days (MHD) | comparison of MHD recorded in baseline month versus 3rd month of treatment | The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study. | Posted | 1 month of baseline recordation followed by 84 days of device use |
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| Secondary | Normalized Reduction in Migraine Headache Days | comparison of MHD recorded in baseline month versus 3rd month of treatment: percentages, active versus placebo | The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study. | Posted | 1 month of baseline recordation followed by 84 days of device use |
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| Secondary | Change in Medication Usage | reduction in acute, prescribed medications in month 3 of treatment versus baseline month | The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study. | Posted | 1 month of baseline recordation followed by 84 days of device use |
| ||||||||||||||||||||||||||
| Secondary | Change in Headache Pain | reduction in subject perceived headache pain scores in month 3 of treatment versus baseline month | The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study. | Posted | 1 month of baseline recordation followed by 84 days of device use |
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| Secondary | Change in Quality of Life | comparison of HIT-6 (headache impact test) scores between baseline month and treatment month 3 | The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study. | Posted | 1 month of baseline recordation followed by 84 days of device use |
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| Secondary | Change in Depression | comparison of BDI-II (Beck depression index) scores between baseline month and treatment month 3 | The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study. | Posted | 1 month of baseline recordation followed by 84 days of device use |
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| Secondary | Change in Anxiety | comparison of BAI (Beck anxiety index) scores between baseline month and treatment month 3 | The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study. | Posted | 1 month of baseline recordation followed by 84 days of device use |
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| Secondary | Change in Sleep Quality | comparison of Pittsburgh Sleep assessment scores between baseline month and treatment month 3 | The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study. | Posted | 1 month of baseline recordation followed by 84 days of device use |
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| Secondary | Additional Treatment Time | comparison of MHD recorded in baseline month versus 6th month of treatment | The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study. | Posted | 1 month of baseline recordation followed by 168 days of device use |
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| Secondary | Sustained Reduction in Migraine Headache Days | comparison of MHD recorded in baseline month versus post-treatment months 7, 8 and 9 | The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study. | Posted | 1 month of baseline recordation followed by 252 days of device use |
|
11 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BID Placebo | Participants self-administered twice-daily inactive/sham treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period). | 0 | 14 | 0 | 14 | 4 | 14 |
| EG001 | BID Active | Participants self-administered twice-daily active treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period). | 0 | 15 | 0 | 15 | 7 | 15 |
| EG002 | QD Active | Participants self-administered once-daily active treatments for 12 weeks (treatment period 1) followed by once-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period). | 0 | 16 | 0 | 16 | 4 | 16 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Ear discomfort, itch, irritation, pruritis or fullness | Product Issues | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Black | Scion NeuroStim, LLC | (919) 260-5528 | rblack@scionneurostim.com |
| Apr 26, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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