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A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Episodic Migraine in Adults (E-BEOND)

Primary Purpose

Episodic Migraine

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dysport®
Dysport®
Placebo
Dysport®
Dysport®
Sponsored by
Ipsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Episodic Migraine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria : Participant must be ≥18 years of age inclusive, at the time of signing the informed consent and privacy/data protection documentation. Participant has a diagnosis for more than 12 months, prior to screening visit, of migraine with aura or migraine without aura according to the International Classification of Headache Disorders definition and diagnostic criteria Migraine onset occurred when participant was <50 years of age. Has baseline number of monthly headache days (MHD) of <15 and baseline number of monthly migraine days (MMD) of ≥6, using eDiary data collected during the 4 weeks nearest to randomisation on Day 1 (but prior to randomisation). Has baseline number of valid diary days ≥22 days collected during the 4 weeks nearest to randomisation on Day 1. Exclusion Criteria : History or current diagnosis of migraine with brainstem aura, retinal migraine, complications of migraine, tension-type headache, trigeminal autonomic cephalalgias, hypnic headache, hemicrania continua, or new daily persistent headache. Headache attributed to another disorder (e.g. secondary headaches), except medication overuse headache, which is permitted. Use of any of the following medications in the specified timeframe prior to start of completion of the screening daily headache eDiary: a. Within 24 weeks i. Botulinum toxin for migraine (or for any other medical/aesthetic reason within 16 weeks) b. Within 12 weeks i. CGRP antagonists (monoclonal antibody or gepant) for preventive treatment of migraine (acute treatment of headache/migraine with a gepant is permitted) ii. Cannabinol or other types of cannabinoids c. Within 4 weeks i. Anaesthetic or steroid injection in any region targeted for injection with study intervention ii. Use of medical device to treat migraine (e.g. non-invasive neuromodulation therapies such as nerve stimulation (gammaCore), transcranial magnetic stimulation (cephaly), external trigeminal nerve stimulation, transcutaneous electrical nerve stimulation, and peripheral neuroelectrical stimulation) iii. Other interventions for migraine assessed to interfere with study evaluations (e.g. acupuncture in head and neck region, cranial traction, nociceptive trigeminal inhibition, occipital nerve block treatments, and dental splints for headache) iv. Use of opioids or barbiturates for more than 2 days/month. Note: participants are permitted to take one concomitant migraine preventative treatment (not listed above); however, the dose of this medication should be stable for ≥3 months before start of the screening eDiary.

Sites / Locations

  • Neurology Center of North Orange County
  • Visionary Investigators Network (VIN)
  • Robbins Headache Clinic
  • MD Fort Wayne Neurological Center
  • Blue Sky MD
  • OrthoNeuro
  • Research Your HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Dysport® dose "A"

Dysport® dose "B"

Placebo - Dysport dose "A"

Placebo - Dysport dose "B"

Arm Description

Participant will receive four treatment cycles, each separated by an interval of 12 weeks. Double-blind placebo-controlled (DBPC) Phase: Dysport® dose "A" administered intramuscularly on Day 1 and Week 12. Extension Phase: Dysport® dose "A" administered intramuscularly at Week 24 and Week 36 (final follow-up at Week 48)

Participant will receive four treatment cycles, each separated by an interval of 12 weeks. DBPC Phase: Dysport® dose "B" administered intramuscularly on Day 1 and Week 12. Extension Phase: Dysport® dose "B" administered intramuscularly at Week 24 and Week 36 (final follow-up at Week 48)

Participant will receive four treatment cycles, each separated by an interval of 12 weeks. DBPC Phase: Placebo dose "A" administered intramuscularly on Day 1 and Week 12. Extension Phase: Dysport® dose "A" administered intramuscularly at Week 24 and Week 36 (final follow-up at Week 48).

Participant will receive four treatment cycles, each separated by an interval of 12 weeks. DBPC Phase: Placebo dose "B" administered intramuscularly on Day 1 and Week 12. Extension Phase: Dysport® dose "B" administered intramuscularly at Week 24 and Week 36 (final follow-up at Week 48).

Outcomes

Primary Outcome Measures

Change from baseline in monthly migraine days (MMD)
The monthly migraine days (MMD) is assessed by a daily eDiary, completed by the participant, to evaluate the efficacy of Dysport® compared to placebo.

Secondary Outcome Measures

Change from baseline in MMD of ≥50%
The monthly migraine days (MMD) is assessed by a daily eDiary.
Change from baseline in MMD of ≥75%
The monthly migraine days (MMD) is assessed by a daily eDiary.
Cumulative number of MMD
The cumulative number of monthly migraine days (MMD) is assessed by a daily eDiary.
Change from baseline in MMD of moderate or severe intensity
The intensity of MMD is assessed by a daily eDiary.
Change from baseline in monthly headache days (MHD) of moderate or severe intensity
The intensity of monthly headache days (MHD) is assessed by a daily eDiary.
Change from baseline in MHD of moderate or severe intensity of ≥50%
The intensity of monthly headache days (MHD) is assessed by a daily eDiary.
Change from baseline in MHD of moderate or severe intensity of ≥75%
The intensity of monthly headache days (MHD) is assessed by a daily eDiary.
Cumulative number of MHD of moderate to severe intensity
The cumulative number of monthly headache days (MHD) is assessed by a daily eDiary.
Change from baseline in the number of days per month of acute migraine medication intake
The acute migraine medication intake will be recorded in the daily eDiary Acute migraine medication is defined as triptan, ergotamine, gepant, or ditan
Headache medication overuser (yes, no)
The headache medication overuse will be assessed by a concomitant medication log completed at each visit and acute medication taken to treat acute attack will be recorded in the daily eDiary. The headache medication overuse is defined as a participant with ≥10 days/month if ergotamine, triptan, gepant, ditan, opioid or combination analgesic, or ≥15 days/month if non-opioid analgesic (such as paracetamol, aspirin, NSAID)
Use of acute migraine medication (yes or no)
The use of acute migraine medication will be recorded in the daily eDiary.
Patient's Global Impression of Change (PGIC) score
The PGIC will be assessed by a questionnaire (7-point scale, score of 1 indicates very much improved and score of 7 indicates very much worse)
Change from baseline of ≥1 and ≥2 grades in PGIC score
The PGIC will be assessed by a questionnaire (7-point scale, score of 1 indicates very much improved and score of 7 indicates very much worse)
Change from baseline in role function restrictive domain of Migraine Specific Quality of Life Questionnaire (MSQ)
The MSQ will be assessed by a questionnaire (Scores range from 0-100, higher scores indicate a better quality of life)
Change from baseline in total MSQ score
The MSQ will be assessed by a questionnaire (Scores range from 0-100, higher scores indicate a better quality of life)
Change in MSQ score to the minimally important difference/change (MID/MIC)
The MSQ will be assessed by a questionnaire (Scores range from 0-100, higher scores indicate a better quality of life)
Change from baseline in total 6-item Headache Impact Test (HIT-6) score
The HIT-6 will be assessed by a questionnaire (scores range from 36-78 and higher scores indicate a greater impact of headache on subject's life)
Change in total 6-item Headache Impact Text (HIT-6) score to the minimally important difference/change (MID/MIC)
The HIT-6 will be assessed by a questionnaire (scores range from 36-78 and higher scores indicate a greater impact of headache on subject's life)
Change from baseline in Short Form 12 (SF-12) Questionnaire score
The SF-12 will be assessed by a questionnaire (scores range from 0-100, with higher scores indicating better functioning)
Change from baseline to Chronic migraine status
Transition to Chronic migraine status will be assessed by the daily eDiary and defined as number of participants with ≥15 MHD and ≥8 MMD
Time to onset of effect
Time to onset of effect is defined as the first time point post randomisation where MMD is reduced from baseline ≥50%
Incidence of Treatment emergent adverse event (TEAEs)
An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Percentage of Participants with clinically significant changes in vital signs
Percentage of participants with clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator.
Percentage of participants with clinically significant laboratory parameters (blood chemistry, haematology)
Percentage of participants with clinically significant change in laboratory parameters (blood chemistry, hematology and coagulation) will be reported. The clinical significance will graded by the investigator.
Treatment-emergence of suicidal ideation/suicidal behaviour
It will be assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) questionnaire that consists of 4 subscales: Ideation severity subscale: questions answered yes/no, severity of ideation scored 1-5 with 5 being most severe Intensity of ideation subscale : scores range from 2-25 with higher scores indicating more severe intensity of ideation. Suicide behaviour subscale:4 types of suicidal behaviours are scored yes/no Behaviour Lethality subscale: actual lethality/medical damage scores 0-5, with 5 being most severe (death) and potential lethality scores 0-2 with 2 being more potentially lethal.
Percentage of participants with Binding antibodies to Dysport®
It will be assessed by collecting blood samples at baseline and Week 24. The determination of putative antibodies against BoNT-A will be evaluated using a validated method of electrochemiluminescence assays (ECLA) for the presence of binding antibodies to BoNT-A.
Percentage of participants with neutralising antibodies to Dysport®
It will be performed only with confirmed positive samples in ECLA (confirmation of presence of binding antibodies) . The characterization of antibodies against BoNT-A will be evaluated using a validated method of cell-based assays (CBA) for the presence of neutralising antibodies to BoNT-A

Full Information

First Posted
September 14, 2023
Last Updated
October 12, 2023
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT06047457
Brief Title
A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Episodic Migraine in Adults
Acronym
E-BEOND
Official Title
A Phase III, Randomised, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study With Extension Phase to Evaluate the Efficacy and Safety of Dysport® for the Prevention of Episodic Migraine in Adult Participants
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 29, 2023 (Actual)
Primary Completion Date
January 26, 2026 (Anticipated)
Study Completion Date
January 26, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to understand the safety and effectiveness of the study drug, Dysport® when compared with placebo in preventing episodic migraine. A migraine is a headache with severe throbbing pain or a pulsating sensation, usually on one side of the head, and is often accompanied by feeling or being sick and a sensitivity to bright lights and sound. Episodic Migraine is defined as having less than 15 days of headache a month with at least 6 days with migraine headaches. Migraines are caused by a series of events which cause the brain to get stimulated / activated, which results in the release of chemicals that cause pain. Dysport® is a formulation of Botulinum toxin type A (BoNT-A), a medication that stops the release of these chemical messengers. The study will consist of 3 periods: A 'screening period' of 6 to 12 weeks to assess whether the participant can take part to the study and requires 1 visit. A first Treatment Phase of 24 weeks. On Day 1 and at Week 12 of the first Treatment Phase, participants will receive injections into various muscles across the head, neck, face and shoulders. The injections will contain either a dose "A" or a dose ''B'' of Dysport® or a placebo (an inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied). Participants will make 4 visits to the clinic in person and have 4 remote (online) visits. A second Treatment Phase of 24 weeks (extension phase). At Week 24 and at Week 36, all participants will get Dysport® (dose "A" or dose "B"). There will be 3 in person visits and 4 remote visits. Participants will need to complete an e-diary and questionnaires throughout the study. Participants will undergo blood samplings, urine collections, physical examinations, and clinical evaluations. They may continue some other medications, but the details need to be recorded. The total study duration for a participant will be up to 60 weeks (approx. 14 months).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Episodic Migraine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
714 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dysport® dose "A"
Arm Type
Experimental
Arm Description
Participant will receive four treatment cycles, each separated by an interval of 12 weeks. Double-blind placebo-controlled (DBPC) Phase: Dysport® dose "A" administered intramuscularly on Day 1 and Week 12. Extension Phase: Dysport® dose "A" administered intramuscularly at Week 24 and Week 36 (final follow-up at Week 48)
Arm Title
Dysport® dose "B"
Arm Type
Experimental
Arm Description
Participant will receive four treatment cycles, each separated by an interval of 12 weeks. DBPC Phase: Dysport® dose "B" administered intramuscularly on Day 1 and Week 12. Extension Phase: Dysport® dose "B" administered intramuscularly at Week 24 and Week 36 (final follow-up at Week 48)
Arm Title
Placebo - Dysport dose "A"
Arm Type
Placebo Comparator
Arm Description
Participant will receive four treatment cycles, each separated by an interval of 12 weeks. DBPC Phase: Placebo dose "A" administered intramuscularly on Day 1 and Week 12. Extension Phase: Dysport® dose "A" administered intramuscularly at Week 24 and Week 36 (final follow-up at Week 48).
Arm Title
Placebo - Dysport dose "B"
Arm Type
Placebo Comparator
Arm Description
Participant will receive four treatment cycles, each separated by an interval of 12 weeks. DBPC Phase: Placebo dose "B" administered intramuscularly on Day 1 and Week 12. Extension Phase: Dysport® dose "B" administered intramuscularly at Week 24 and Week 36 (final follow-up at Week 48).
Intervention Type
Biological
Intervention Name(s)
Dysport®
Intervention Description
Dose "A" U /Injection (U/I) , Intramuscular (IM) on every 12 weeks during a period of 36 weeks with a total of 4 injections.
Intervention Type
Biological
Intervention Name(s)
Dysport®
Intervention Description
Dose "B" U/I, IM on every 12 weeks during a period of 36 weeks with a total of 4 injections.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
"0" U/I, IM on Day 1 and Week 12 with a total of 2 injections.
Intervention Type
Biological
Intervention Name(s)
Dysport®
Intervention Description
Dose "A" U/I, IM on Week 24 and Week 36 with a total of 2 injections.
Intervention Type
Biological
Intervention Name(s)
Dysport®
Intervention Description
Dose "B" U/I, IM on Week 24 and Week 36 with a total of 2 injections.
Primary Outcome Measure Information:
Title
Change from baseline in monthly migraine days (MMD)
Description
The monthly migraine days (MMD) is assessed by a daily eDiary, completed by the participant, to evaluate the efficacy of Dysport® compared to placebo.
Time Frame
Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)
Secondary Outcome Measure Information:
Title
Change from baseline in MMD of ≥50%
Description
The monthly migraine days (MMD) is assessed by a daily eDiary.
Time Frame
Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)
Title
Change from baseline in MMD of ≥75%
Description
The monthly migraine days (MMD) is assessed by a daily eDiary.
Time Frame
Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)
Title
Cumulative number of MMD
Description
The cumulative number of monthly migraine days (MMD) is assessed by a daily eDiary.
Time Frame
From Day 1 to Week 24
Title
Change from baseline in MMD of moderate or severe intensity
Description
The intensity of MMD is assessed by a daily eDiary.
Time Frame
Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)
Title
Change from baseline in monthly headache days (MHD) of moderate or severe intensity
Description
The intensity of monthly headache days (MHD) is assessed by a daily eDiary.
Time Frame
Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)
Title
Change from baseline in MHD of moderate or severe intensity of ≥50%
Description
The intensity of monthly headache days (MHD) is assessed by a daily eDiary.
Time Frame
Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)
Title
Change from baseline in MHD of moderate or severe intensity of ≥75%
Description
The intensity of monthly headache days (MHD) is assessed by a daily eDiary.
Time Frame
Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)
Title
Cumulative number of MHD of moderate to severe intensity
Description
The cumulative number of monthly headache days (MHD) is assessed by a daily eDiary.
Time Frame
From Day 1 to Week 24
Title
Change from baseline in the number of days per month of acute migraine medication intake
Description
The acute migraine medication intake will be recorded in the daily eDiary Acute migraine medication is defined as triptan, ergotamine, gepant, or ditan
Time Frame
Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)
Title
Headache medication overuser (yes, no)
Description
The headache medication overuse will be assessed by a concomitant medication log completed at each visit and acute medication taken to treat acute attack will be recorded in the daily eDiary. The headache medication overuse is defined as a participant with ≥10 days/month if ergotamine, triptan, gepant, ditan, opioid or combination analgesic, or ≥15 days/month if non-opioid analgesic (such as paracetamol, aspirin, NSAID)
Time Frame
Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)
Title
Use of acute migraine medication (yes or no)
Description
The use of acute migraine medication will be recorded in the daily eDiary.
Time Frame
Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)
Title
Patient's Global Impression of Change (PGIC) score
Description
The PGIC will be assessed by a questionnaire (7-point scale, score of 1 indicates very much improved and score of 7 indicates very much worse)
Time Frame
At Week 12 and Week 24
Title
Change from baseline of ≥1 and ≥2 grades in PGIC score
Description
The PGIC will be assessed by a questionnaire (7-point scale, score of 1 indicates very much improved and score of 7 indicates very much worse)
Time Frame
At Week 12 and Week 24
Title
Change from baseline in role function restrictive domain of Migraine Specific Quality of Life Questionnaire (MSQ)
Description
The MSQ will be assessed by a questionnaire (Scores range from 0-100, higher scores indicate a better quality of life)
Time Frame
At Week 12 and Week 24
Title
Change from baseline in total MSQ score
Description
The MSQ will be assessed by a questionnaire (Scores range from 0-100, higher scores indicate a better quality of life)
Time Frame
At Week 12 and Week 24
Title
Change in MSQ score to the minimally important difference/change (MID/MIC)
Description
The MSQ will be assessed by a questionnaire (Scores range from 0-100, higher scores indicate a better quality of life)
Time Frame
At Week 12 and Week 24
Title
Change from baseline in total 6-item Headache Impact Test (HIT-6) score
Description
The HIT-6 will be assessed by a questionnaire (scores range from 36-78 and higher scores indicate a greater impact of headache on subject's life)
Time Frame
At Week 12 and Week 24
Title
Change in total 6-item Headache Impact Text (HIT-6) score to the minimally important difference/change (MID/MIC)
Description
The HIT-6 will be assessed by a questionnaire (scores range from 36-78 and higher scores indicate a greater impact of headache on subject's life)
Time Frame
At Week 12 and Week 24
Title
Change from baseline in Short Form 12 (SF-12) Questionnaire score
Description
The SF-12 will be assessed by a questionnaire (scores range from 0-100, with higher scores indicating better functioning)
Time Frame
At Week 12 and Week 24
Title
Change from baseline to Chronic migraine status
Description
Transition to Chronic migraine status will be assessed by the daily eDiary and defined as number of participants with ≥15 MHD and ≥8 MMD
Time Frame
At Week 24 (Week 21-24)
Title
Time to onset of effect
Description
Time to onset of effect is defined as the first time point post randomisation where MMD is reduced from baseline ≥50%
Time Frame
From first time point post randomisation to Week 24
Title
Incidence of Treatment emergent adverse event (TEAEs)
Description
An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time Frame
Up to Week 24
Title
Percentage of Participants with clinically significant changes in vital signs
Description
Percentage of participants with clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator.
Time Frame
From baseline up to Week 24
Title
Percentage of participants with clinically significant laboratory parameters (blood chemistry, haematology)
Description
Percentage of participants with clinically significant change in laboratory parameters (blood chemistry, hematology and coagulation) will be reported. The clinical significance will graded by the investigator.
Time Frame
From baseline up to Week 24
Title
Treatment-emergence of suicidal ideation/suicidal behaviour
Description
It will be assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) questionnaire that consists of 4 subscales: Ideation severity subscale: questions answered yes/no, severity of ideation scored 1-5 with 5 being most severe Intensity of ideation subscale : scores range from 2-25 with higher scores indicating more severe intensity of ideation. Suicide behaviour subscale:4 types of suicidal behaviours are scored yes/no Behaviour Lethality subscale: actual lethality/medical damage scores 0-5, with 5 being most severe (death) and potential lethality scores 0-2 with 2 being more potentially lethal.
Time Frame
From baseline up to Week 24
Title
Percentage of participants with Binding antibodies to Dysport®
Description
It will be assessed by collecting blood samples at baseline and Week 24. The determination of putative antibodies against BoNT-A will be evaluated using a validated method of electrochemiluminescence assays (ECLA) for the presence of binding antibodies to BoNT-A.
Time Frame
At Week 24
Title
Percentage of participants with neutralising antibodies to Dysport®
Description
It will be performed only with confirmed positive samples in ECLA (confirmation of presence of binding antibodies) . The characterization of antibodies against BoNT-A will be evaluated using a validated method of cell-based assays (CBA) for the presence of neutralising antibodies to BoNT-A
Time Frame
At Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria : Participant must be ≥18 years of age inclusive, at the time of signing the informed consent and privacy/data protection documentation. Participant has a diagnosis for more than 12 months, prior to screening visit, of migraine with aura or migraine without aura according to the International Classification of Headache Disorders definition and diagnostic criteria Migraine onset occurred when participant was <50 years of age. Has baseline number of monthly headache days (MHD) of <15 and baseline number of monthly migraine days (MMD) of ≥6, using eDiary data collected during the 4 weeks nearest to randomisation on Day 1 (but prior to randomisation). Has baseline number of valid diary days ≥22 days collected during the 4 weeks nearest to randomisation on Day 1. Exclusion Criteria : History or current diagnosis of migraine with brainstem aura, retinal migraine, complications of migraine, tension-type headache, trigeminal autonomic cephalalgias, hypnic headache, hemicrania continua, or new daily persistent headache. Headache attributed to another disorder (e.g. secondary headaches), except medication overuse headache, which is permitted. Use of any of the following medications in the specified timeframe prior to start of completion of the screening daily headache eDiary: a. Within 24 weeks i. Botulinum toxin for migraine (or for any other medical/aesthetic reason within 16 weeks) b. Within 12 weeks i. CGRP antagonists (monoclonal antibody or gepant) for preventive treatment of migraine (acute treatment of headache/migraine with a gepant is permitted) ii. Cannabinol or other types of cannabinoids c. Within 4 weeks i. Anaesthetic or steroid injection in any region targeted for injection with study intervention ii. Use of medical device to treat migraine (e.g. non-invasive neuromodulation therapies such as nerve stimulation (gammaCore), transcranial magnetic stimulation (cephaly), external trigeminal nerve stimulation, transcutaneous electrical nerve stimulation, and peripheral neuroelectrical stimulation) iii. Other interventions for migraine assessed to interfere with study evaluations (e.g. acupuncture in head and neck region, cranial traction, nociceptive trigeminal inhibition, occipital nerve block treatments, and dental splints for headache) iv. Use of opioids or barbiturates for more than 2 days/month. Note: participants are permitted to take one concomitant migraine preventative treatment (not listed above); however, the dose of this medication should be stable for ≥3 months before start of the screening eDiary.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ipsen Clinical Study Enquiries
Phone
See email
Email
clinical.trials@ipsen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Neurology Center of North Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Visionary Investigators Network (VIN)
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Robbins Headache Clinic
City
Riverwoods
State/Province
Illinois
ZIP/Postal Code
60015
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
MD Fort Wayne Neurological Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Blue Sky MD
City
Hendersonville
State/Province
North Carolina
ZIP/Postal Code
28792
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
OrthoNeuro
City
New Albany
State/Province
Ohio
ZIP/Postal Code
43054
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Your Health
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
IPD Sharing Time Frame
Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
IPD Sharing Access Criteria
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
IPD Sharing URL
https://vivli.org/members/ourmembers/

Learn more about this trial

A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Episodic Migraine in Adults

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