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A Study to Test if Fremanezumab Reduces Headache in Participants With Posttraumatic Headache (PTH)

Primary Purpose

Post-Traumatic Headache

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Fremanezumab

Placebo

About this trial

This is an interventional prevention trial for Post-Traumatic Headache focused on measuring posttraumatic headache (PTH)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The participant has a body weight greater than or equal to (≥) 45 kilograms (kg).
Traumatic injury to the head has occurred, defined as a structural or functional injury resulting from the action of external forces.
The participant has a diagnosis of PTH.
The participant is not using preventive medications for headache.
Women of childbearing potential whose male partners are potentially fertile (that is, no vasectomy) must use highly effective birth control methods for the duration of the study and for 30 weeks after the last study drug administration. Men must be sterile or, if they are potentially fertile or reproductively competent (that is, not surgically or congenitally sterile) and their female partners are of childbearing potential, must use, together with their female partners, acceptable birth control methods for the duration of the study and for 30 weeks after the last study drug administration.

NOTE- Additional criteria apply, please contact the investigator for more information.

Exclusion Criteria:

The participant has a previous history of brain imaging showing evidence of intracerebral hemorrhage, subdural or epidural hematomas, or subarachnoid hemorrhage as a consequence of the traumatic head injury. Brain images with structurally insignificant changes, as discussed and approved by the sponsor, will be reviewed by the sponsor on a case-by-case basis.
The participant has PTH attributed to craniotomy.
The participant has whiplash and subsequent headache but no history of head injury or concussion.
The participant is using analgesic medications containing opioids (including codeine) or a barbiturate on average more than 15 days per month.
The participant has had exposure to a monoclonal antibody (mAb) targeting the calcitonin gene-related peptide (CGRP) pathway (erenumab, eptinezumab, galcanezumab, and fremanezumab) during the 6 months prior to the day of the screening visit.
The participant is currently being treated with onabotulinumtoxinA (for example, Botox, Dysport, Xeomin) application in the head or neck or received any such injection during the 3 months prior to the screening visit.
The participant has been implanted with any electronic devices for headache prevention during the 3 months prior to the screening visit or is currently using any implanted or externally applied stimulator or device.
The participant has been treated with a nerve block for head and/or neck during the 3 months prior to the screening visit.
The participant is a pregnant or lactating woman or plans to become pregnant during the study.

NOTE- Additional criteria apply, please contact the investigator for more information.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fremanezumab

Placebo

Arm Description

Participants will receive fremanezumab 675 milligrams (mg) administered as 3 subcutaneous (SC) injections (225 mg/1.5 milliliters [mL] each) at randomization (Week 0), Weeks 4, and 8 during the DB treatment period. Participants who complete the DB treatment period and continue into the OL treatment period will receive fremanezumab 675 mg administered as 3 SC injections (225 mg/1.5 mL each) at Weeks 12, 16, and 20 during the OL treatment period.

Participants will receive placebo matching to fremanezumab administered as 3 SC injections (1.5 mL each) at randomization (Week 0), Weeks 4, and 8 during the DB treatment period. Participants who complete the DB treatment period and continue into the OL treatment period will receive fremanezumab 675 mg administered as 3 SC injections (225 mg/1.5 mL each) at Weeks 12, 16, and 20 during the OL treatment period.

Outcomes

Primary Outcome Measures

DB Period: Mean Change From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During the 12-Week Treatment Period After the First Dose of Fremanezumab

A headache day was defined as a day when a participant reported a headache of at least moderate severity. Monthly averages were derived and normalized to 28 days equivalent by the following formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in the e-diary over the relevant period) * 28. The change was calculated as post-baseline value - baseline value. Least square (LS) mean was calculated using analysis of covariance (ANCOVA) model with the duration of post traumatic headache history (less than 12 month since the brain injury or greater or equal to 12 month since the brain injury) and treatment as fixed effects and the baseline monthly average number of headache days of at least moderate severity as a covariate.

Secondary Outcome Measures

DB Period: Number of Participants Reaching at Least 50% Reduction From Baseline in Monthly Average Number of Headache Days of Any Severity During 12-Week Treatment With Fremanezumab

Monthly averages were derived and normalized to 28 days equivalent by the following formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in the e-diary over the relevant period) * 28.

DB Period: Number of Participants Reaching at Least 50% Reduction From Baseline in the Monthly Average Number of Headache Days of at Least Moderate Severity During 12-Week Treatment With Fremanezumab

DB Period: Number of Participants Reaching at Least 50% Reduction From Baseline in the Monthly Average Number of Headache Days of at Least Moderate Severity During First 4-Week (Month 1), 5- to 8-Week (Month 2), and 9- to 12-Week (Month 3)

DB Period: Change From Baseline in the Number of Headache Days of At Least Moderate Severity During the First 4-Week (Month 1), 5- to 8-Week (Month 2), and 9- to 12-Week (Month 3)

A headache day was defined as a day when a participant reported a headache of at least moderate severity. Monthly averages were derived and normalized to 28 days equivalent by the following formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in the e-diary over the relevant period) * 28. The change was calculated as post-baseline value - baseline value. LS mean was calculated using ANCOVA model with the duration of post traumatic headache history (less than 12 month since the brain injury or greater or equal to 12 month since the brain injury) and treatment as fixed effects and the baseline monthly average number of headache days of at least moderate severity as a covariate. This approach was used in generating the LS mean values only and was not considered to be an additional statistical analysis, no additional statistical analyses are reported for this outcome measure.

DB Period: Change From Baseline in Disability Score, as Measured by the 6-Item Headache Impact Test (HIT-6) Total Score at Week 12 After the First Dose of Fremanezumab

HIT-6 is a tool used to measure the impact headaches have on a participant's normal daily life and ability to function. The HIT-6 consists of 6 items, including pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. Each item was answered on a 5-point Likert scale (6=never, 8=rarely, 10=sometimes, 11=very often, or 13=always), which were summed to produce a total score that ranged from 36 to 78, with larger scores reflecting greater impact of headache on the daily life of the participant.

DB Period: Number of Participants (Responder and Non-Responder) With the Patient Global Impression of Change (PGIC) Scale at Weeks 4, 8, and 12 After the First Dose of Fremanezumab

The PGIC scale is a validated generic tool for the assessment of overall change in the severity of illness following treatment. Participants rated how they felt during assigned time points compared with how they felt before receiving study drug on a 7-point scale, where 1 = No change (or it got worse); 2 = Almost the same, hardly any change at all; 3 = A little better, but no noticeable change; 4 = Somewhat better, but the change has not made any real difference; 5 = Moderately better, and a slight but noticeable change; 6 = Better, and a definite improvement that has made a real and worthwhile difference; and 7 = A great deal better, and a considerable improvement that has made all the difference. Responders were those with a scale of 5 to 7 and non-responders were those with a scale of 1 to 4.

DB Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were defined as AEs occurring at or after the first dose of the study drug. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

OL Period: Number of Participants With TEAEs

An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were defined as AEs occurring at or after the first dose of the study drug. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

DB Period: Number of Participants Who Did Not Complete the Study

Number of participants who did not complete the study due to any reason and due to AEs are reported.

OL Period: Number of Participants Who Did Not Complete the Study

Number of participants who did not complete the study due to any reason and due to AEs are reported.

DB Period: Number of Participants Who Received Concomitant Medications

Concomitant medications included: agents acting on renin-angiotensin system, analgesics, anesthetics, anti-parkinson drugs, antianemic preparations, antibacterials for systemic use, antidiarrheals, intestinal antiinflammatory/antiinfective agents, antiemetics and antinauseants, antiepileptics, antifungals for dermatologiocal use, antihistamines for systemic use, antihypertensives, antiinflammatory and antirheumatics, antineoplastic agents, antiobesity preparations, antipruritics, antithrombotics, antivirals for systemic use, beta blocking agents, calcium channel blockers, cardiac therapy, corticosteroids, cough and cold preparations, diuretics, lipid modifying agents, nasal preparations, thyroid therapy, urologicals, vaccines, psycholeptics, psycoanaleptics, ophthalmologicals, general nutrients, mineral supplements, muscle relaxants, vitamins, drugs used in diabetes, sex hormones and modulators of the genital system, immunosuppresants, drugs for acid related disorders etc.

OL Period: Number of Participants Who Received Concomitant Medications

Concomitant medications included: agents acting on renin-angiotensin system, analgesics, anti-parkinson drugs, antianemic preparations, antibacterials for systemic use, antiemetics and antinauseants, antihistamines for systemic use, antihypertensives, antiinflammatory and antirheumatics, antineoplastic agents, antithrombotics, beta blocking agents, calcium channel blockers, corticosteroids for systemic use, cough and cold preparations, diuretics, lipid modifying agents, nasal preparations, other gynecologicals, other nervous system drugs, thyroid therapy, unspecified herbal and traditional medicine, urologicals, vaccines, psycholeptics, psycoanaleptics, general nutrients, mineral supplements, muscle relaxants, vitamins, sex hormones and modulators of the genital system, drugs for acid related disorders, drugs for constipation, drugs for obstructive airways disease etc.

Number of Participants With Positive Findings on Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)

eC-SSRS is a questionnaire to assess suicidal ideation (severity and intensity) and behavior. Suicidal ideation: A series of 1 -5 questions (with 'yes' or 'no' response) with 5 types of ideation of increasing severity: 1. wish to be dead, 2. non-specific active suicidal thoughts, 3. active suicidal ideation with any methods (not plan) without intent to act, 4. active suicidal ideation with some intent to act, without specific plan, 5. active suicidal ideation with specific plan and intent. A positive finding was defined as a 'yes' response to question 4 or 5.

Number of Participants With Treatment-Emergent Antidrug Antibodies (ADA)

Number of participants with treatment-emergent antidrug antibodies reported.

Full Information

NCT ID

NCT03347188

First Posted

November 14, 2017

Last Updated

December 9, 2022

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03347188

Brief Title

A Study to Test if Fremanezumab Reduces Headache in Participants With Posttraumatic Headache (PTH)

Official Title

A Phase 2, Multicenter, Randomized, Proof-of-Concept, Double-Blind, Placebo-Controlled, Parallel-Group Study, Including an Open-Label Period, Evaluating the Efficacy and Safety of 1 Subcutaneous Dose Regimen of Fremanezumab for the Treatment of Posttraumatic Headache (PTH)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

December 18, 2017 (Actual)

Primary Completion Date

March 13, 2020 (Actual)

Study Completion Date

June 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of fremanezumab in adult participants aged 18 to 70 years, inclusive, for the prevention of PTH. The study will include a double-blind (DB) treatment period (12 weeks) and an open-label (OL) treatment period (12 weeks).

6. Conditions and Keywords

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

Post-Traumatic Headache

Keywords

posttraumatic headache (PTH)

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

87 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fremanezumab

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Fremanezumab

Other Intervention Name(s)

TEV-48125

Intervention Description

Fremanezumab will be administered per dose and schedule specified in the arm.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo matching to fremanezumab will be administered per schedule specified in the arm.

Primary Outcome Measure Information:

Title

DB Period: Mean Change From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During the 12-Week Treatment Period After the First Dose of Fremanezumab

Description

Time Frame

Baseline (Day -28 to Day -1), up to Week 12

Secondary Outcome Measure Information:

Title

DB Period: Number of Participants Reaching at Least 50% Reduction From Baseline in Monthly Average Number of Headache Days of Any Severity During 12-Week Treatment With Fremanezumab

Description

Time Frame

Baseline (Day -28 to Day-1) up to Week 12

Title

DB Period: Number of Participants Reaching at Least 50% Reduction From Baseline in the Monthly Average Number of Headache Days of at Least Moderate Severity During 12-Week Treatment With Fremanezumab

Description

Time Frame

Baseline (Day -28 to Day-1) up to Week 12

Title

Description

Time Frame

Baseline (Day -28 to Day-1) up to Months 1, 2, and 3

Title

DB Period: Change From Baseline in the Number of Headache Days of At Least Moderate Severity During the First 4-Week (Month 1), 5- to 8-Week (Month 2), and 9- to 12-Week (Month 3)

Description

A headache day was defined as a day when a participant reported a headache of at least moderate severity. Monthly averages were derived and normalized to 28 days equivalent by the following formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in the e-diary over the relevant period) * 28. The change was calculated as post-baseline value - baseline value. LS mean was calculated using ANCOVA model with the duration of post traumatic headache history (less than 12 month since the brain injury or greater or equal to 12 month since the brain injury) and treatment as fixed effects and the baseline monthly average number of headache days of at least moderate severity as a covariate. This approach was used in generating the LS mean values only and was not considered to be an additional statistical analysis, no additional statistical analyses are reported for this outcome measure.

Time Frame

Baseline (Day -28 to Day -1), up to Months 1, 2, and 3

Title

DB Period: Change From Baseline in Disability Score, as Measured by the 6-Item Headache Impact Test (HIT-6) Total Score at Week 12 After the First Dose of Fremanezumab

Description

Time Frame

Baseline (Day -28 to Day -1), Week 12

Title

DB Period: Number of Participants (Responder and Non-Responder) With the Patient Global Impression of Change (PGIC) Scale at Weeks 4, 8, and 12 After the First Dose of Fremanezumab

Description

Time Frame

Weeks 4, 8, and 12

Title

DB Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Description

Time Frame

Baseline (Day -28 to -1) up to Week 12

Title

OL Period: Number of Participants With TEAEs

Description

Time Frame

Week 12 up to Week 24

Title

DB Period: Number of Participants Who Did Not Complete the Study

Description

Number of participants who did not complete the study due to any reason and due to AEs are reported.

Time Frame

Baseline (Day -28 to Day -1) up to Week 12

Title

OL Period: Number of Participants Who Did Not Complete the Study

Description

Number of participants who did not complete the study due to any reason and due to AEs are reported.

Time Frame

Week 12 up to Week 24

Title

DB Period: Number of Participants Who Received Concomitant Medications

Description

Time Frame

Baseline (Day -28 to Day -1) up to Week 12

Title

OL Period: Number of Participants Who Received Concomitant Medications

Description

Time Frame

Week 12 up to Week 24

Title

Number of Participants With Positive Findings on Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)

Description

Time Frame

Baseline (Day -28 to Day -1) up to Week 24

Title

Number of Participants With Treatment-Emergent Antidrug Antibodies (ADA)

Description

Number of participants with treatment-emergent antidrug antibodies reported.

Time Frame

Baseline (Day -28 to Day -1) up to Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The participant has a body weight greater than or equal to (≥) 45 kilograms (kg). Traumatic injury to the head has occurred, defined as a structural or functional injury resulting from the action of external forces. The participant has a diagnosis of PTH. The participant is not using preventive medications for headache. Women of childbearing potential whose male partners are potentially fertile (that is, no vasectomy) must use highly effective birth control methods for the duration of the study and for 30 weeks after the last study drug administration. Men must be sterile or, if they are potentially fertile or reproductively competent (that is, not surgically or congenitally sterile) and their female partners are of childbearing potential, must use, together with their female partners, acceptable birth control methods for the duration of the study and for 30 weeks after the last study drug administration. NOTE- Additional criteria apply, please contact the investigator for more information. Exclusion Criteria: The participant has a previous history of brain imaging showing evidence of intracerebral hemorrhage, subdural or epidural hematomas, or subarachnoid hemorrhage as a consequence of the traumatic head injury. Brain images with structurally insignificant changes, as discussed and approved by the sponsor, will be reviewed by the sponsor on a case-by-case basis. The participant has PTH attributed to craniotomy. The participant has whiplash and subsequent headache but no history of head injury or concussion. The participant is using analgesic medications containing opioids (including codeine) or a barbiturate on average more than 15 days per month. The participant has had exposure to a monoclonal antibody (mAb) targeting the calcitonin gene-related peptide (CGRP) pathway (erenumab, eptinezumab, galcanezumab, and fremanezumab) during the 6 months prior to the day of the screening visit. The participant is currently being treated with onabotulinumtoxinA (for example, Botox, Dysport, Xeomin) application in the head or neck or received any such injection during the 3 months prior to the screening visit. The participant has been implanted with any electronic devices for headache prevention during the 3 months prior to the screening visit or is currently using any implanted or externally applied stimulator or device. The participant has been treated with a nerve block for head and/or neck during the 3 months prior to the screening visit. The participant is a pregnant or lactating woman or plans to become pregnant during the study. NOTE- Additional criteria apply, please contact the investigator for more information.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Teva Medical Expert, MD

Organizational Affiliation

Teva Branded Pharmaceutical Products R&D, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Teva Investigational Site 14065

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85018

Country

United States

Facility Name

Teva Investigational Site 14069

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85259-5452

Country

United States

Facility Name

Teva Investigational Site 14048

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Teva Investigational Site 30236

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Teva Investigational Site 14052

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Teva Investigational Site 14053

City

Los Angeles

State/Province

California

ZIP/Postal Code

90073

Country

United States

Facility Name

Teva Investigational Site 14060

City

San Diego

State/Province

California

ZIP/Postal Code

92161

Country

United States

Facility Name

Teva Investigational Site 14054

City

San Francisco

State/Province

California

ZIP/Postal Code

94109

Country

United States

Facility Name

Teva Investigational Site 14045

City

Fairfield

State/Province

Connecticut

ZIP/Postal Code

06824

Country

United States

Facility Name

Teva Investigational Site 14063

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Teva Investigational Site 14041

City

North Miami

State/Province

Florida

ZIP/Postal Code

33161

Country

United States

Facility Name

Teva Investigational Site 14056

City

Tampa

State/Province

Florida

ZIP/Postal Code

33609

Country

United States

Facility Name

Teva Investigational Site 14057

City

Riverwoods

State/Province

Illinois

ZIP/Postal Code

60015

Country

United States

Facility Name

Teva Investigational Site 14067

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46256

Country

United States

Facility Name

Teva Investigational Site 14058

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40207

Country

United States

Facility Name

Teva Investigational Site 14061

City

Waltham

State/Province

Massachusetts

ZIP/Postal Code

02451

Country

United States

Facility Name

Teva Investigational Site 14051

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64128-2226

Country

United States

Facility Name

Teva Investigational Site 14046

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Teva Investigational Site 14043

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65810

Country

United States

Facility Name

Teva Investigational Site 14119

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

Facility Name

Teva Investigational Site 14229

City

Amherst

State/Province

New York

ZIP/Postal Code

14226

Country

United States

Facility Name

Teva Investigational Site 14118

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Facility Name

Teva Investigational Site 14047

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

Teva Investigational Site 14114

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27713

Country

United States

Facility Name

Teva Investigational Site 14059

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

Teva Investigational Site 14049

City

Portland

State/Province

Oregon

ZIP/Postal Code

97225

Country

United States

Facility Name

Teva Investigational Site 14064

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Teva Investigational Site 14040

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15236

Country

United States

Facility Name

Teva Investigational Site 14230

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Teva Investigational Site 14055

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-8565

Country

United States

Facility Name

Teva Investigational Site 14050

City

Waco

State/Province

Texas

ZIP/Postal Code

76711

Country

United States

Facility Name

Teva Investigational Site 14113

City

Spokane

State/Province

Washington

ZIP/Postal Code

99202

Country

United States

Facility Name

Teva Investigational Site 14044

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Study to Test if Fremanezumab Reduces Headache in Participants With Posttraumatic Headache (PTH)

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A Study to Test if Fremanezumab Reduces Headache in Participants With Posttraumatic Headache (PTH)

Post-Traumatic Headache

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial