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A Study to Explore the Long-Term Safety and Efficacy of Fremanezumab (TEV-48125) for the Prevention of Cluster Headache (ENFORCE)

Primary Purpose

Cluster Headache

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Fremanezumab

About this trial

This is an interventional treatment trial for Cluster Headache

Eligibility Criteria

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

Inclusion Criteria:

The participant completes either the Phase 3 pivotal study for ECH (Study TV48125-CNS-30056) or the Phase 3 pivotal study for CCH (Study TV48125-CNS-30057) without important protocol deviations related to participant safety and participant compliance.
Prior to 15 June 2018, participants from the ECH study and the CCH study were enrolled. After 15 June 2018, only participants who participated in the ECH study (Study TV48125-CNS-30056) will be enrolled for active treatment.
In addition, participants who do not complete the pivotal efficacy studies, and participants who complete the pivotal efficacy studies but will not continue treatment during this long-term safety study, will be offered to enroll in this study for the purpose of evaluating ADAs, and safety (adverse events and concomitant medications) approximately 7.5 months after administration of the last dose of the IMP.
- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

Any finding that, in the judgment of the investigator, is a clinically significant abnormality, including serum chemistry, hematology, coagulation, and urinalysis test values (abnormal tests may be repeated for confirmation)
- Additional criteria apply, please contact the investigator for more information

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Fremanezumab 225 mg Monthly

Fremanezumab 675/225 mg Monthly

Fremanezumab 675 mg Quarterly

Arm Description

Participants with ECH or CCH who received fremanezumab at 900 mg intravenous (IV) infusion at Week 0 and fremanezumab at 225 mg subcutaneous (SC) injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30056 or TV48125-CNS-30057, and participants with CCH who received fremanezumab at 675 mg SC injection at Week 0 and placebo SC injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30057; will receive fremanezumab at 225 mg SC injection monthly (approximately every 4 weeks, administered as single SC injection of fremanezumab at 225 mg [225 mg/1.5 milliliter {mL}] at Week 0 and 36; and 2 placebo SC injections at Weeks 0, 12, 24, and 36 for blinding in participants rolled over from Study TV48125-CNS-30056; fremanezumab at 225 mg as a single SC injection (225 mg/1.5 mL) at Week 0, 12, 24, and 36; 2 SC injections of placebo at Week 0 for blinding in participants rolled over from Study TV48125-CNS-30057) through Week 36 in this study.

Participants with CCH who received placebo IV infusion and SC injection at Week 0 and placebo SC injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30057; will receive fremanezumab 675 mg SC injection as loading dose (administered as 3 SC injections of fremanezumab at 225 mg [225 mg/1.5 mL] at Week 0) followed by monthly (approximately every 4 weeks) fremanezumab at 225 mg SC injection (administered as single SC injection of fremanezumab at 225 mg [225 mg/1.5 mL] at Weeks 12, 24, and 36) through Week 36.

Participants with ECH who received fremanezumab at 675 mg SC injection at Week 0 and placebo SC injection at Weeks 4 and 8, respectively in the pivotal study; or placebo IV infusion and SC injection at Week 0 and placebo SC injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30056; will receive fremanezumab at 675 mg SC injection quarterly (approximately every 12 weeks, administered as 3 SC injections of fremanezumab at 225 mg [225 mg/1.5 mL] at Weeks 0 an 36; and single placebo SC injections at Weeks 4, 8, 16, 20, 28, and 32 for blinding) through Week 36.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events (AEs)

An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Relationship of AE to treatment was determined by the Investigator. Serious AEs include death, a life-threatening adverse event, 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 the participant and required medical intervention to prevent the previously listed serious outcomes. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Baseline refers to the baseline values from the pivotal studies.

Number of Participants With Potentially Clinically Significant Abnormal Laboratory Results: Serum Chemistry

Serum chemistry tests with potentially clinically significant abnormal findings included: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), lactate dehydrogenase (LDH) each ≥3*upper limit of normal (ULN); Blood urea nitrogen (BUN) ≥10.71 millimole (mmol)/L; Bilirubin (Total) ≥34.2 micromole/liter (umol/L); and Creatinine ≥177 umol/L. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Baseline refers to the baseline values from the pivotal studies.

Number of Participants With Potentially Clinically Significant Abnormal Laboratory Results: Hematology

Hematology tests with potentially clinically significant abnormal findings included: hemoglobin less than or equal to (≤)115 grams (g)/L (males) or ≤95 g/L (females), leukocytes count ≥20*10^9/L or ≤3*10^9/L, eosinophils ≥10%, hematocrit <0.37 L/L (males) and <0.32 L/L (females), platelets count ≥700*10^9/L or ≤75*10^9/L, absolute neutrophil count (ANC) ≤1*10^9/L. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Baseline refers to the baseline values from the pivotal studies.

Number of Participants With Potentially Clinically Significant Abnormal Laboratory Results: Urinalysis

Urinalysis laboratory tests with potentially clinically significant abnormal findings included: haemoglobin, urine glucose, ketones, urine total protein each ≥2 unit (U) increase from baseline. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Baseline refers to the baseline values from the pivotal studies.

Number of Participants With Shift From Baseline to Endpoint (Last Assessment) in Coagulation Laboratory Test Results

Coagulation parameters included: prothrombin time (PT) (seconds) and prothrombin international normalized ratio (INR). Shifts represented as Baseline - endpoint value (last observed post-baseline value). Shifts from baseline to endpoint were summarized using participant counts grouped into three categories: - Low (below normal range) - Normal (within the normal range of 9.4 to 12.5 seconds) - High (above normal range). Missing PT and prothrombin INR shift data are also presented. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Baseline refers to the baseline values from the pivotal studies.

Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values

Potentially clinically significant abnormal vital signs findings included: Pulse rate ≥120 beats per minute (bpm) and increase from baseline of ≥15 bpm, or ≤50 bpm and decrease from baseline of ≥15 bpm; Systolic blood pressure ≤90 millimeters of mercury (mmHg) and decrease from baseline of ≥20 mmHg, or ≥180 mmHg and increase from baseline of ≥20 mmHg; Diastolic blood pressure ≤50 mmHg and decrease from baseline of ≥15 mmHg, or ≥105 mmHg and increase from baseline of ≥15 mmHg; Temperature >38.3 degrees celsius (°C). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Baseline refers to the baseline values from the pivotal studies.

Number of Participants With Shift From Baseline to Endpoint (Last Assessment) in Electrocardiogram (ECG) Parameters

ECG parameters included: heart rate, PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF), QT interval corrected using the Bazett's formula (QTcB) and RR interval. Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding. Missing ECG shift data are also presented. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Baseline refers to the baseline values from the pivotal studies.

Number of Participants With Abnormal Physical Examination Findings

A complete physical examination included the following organ systems: general appearance; head, eyes, ears, nose, and throat; chest and lungs; heart; abdomen; musculoskeletal; skin; lymph nodes; and neurological. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Baseline refers to the baseline values from the pivotal studies.

Number of Participants With Injection Site Reactions

Number of participants who reported treatment-emergent injection site reactions are summarized. Preferred terms from Medical Dictionary for Regulatory Activities (MedDRA) version 18.1 were offered without a threshold applied. Injection site reactions included injection site erythema, induration, pain, haemorrhage, bruising, rash, warmth, and pruritus. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Baseline refers to the baseline values from the pivotal studies.

Number of Participants With Hypersensitivity/Anaphylaxis Reactions

A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Baseline refers to the baseline values from the pivotal studies.

Number of Participants Who Received Concomitant Medications

Concomitant medications included: agents acting on the renin-angiotensin system, all other therapeutic products (homeopathic), allergens, analgesics, anesthetics, anti-parkinson drugs, antianemic preparations, antibacterials, antibiotics and chemotherapeutics for dermatological use, antidiarrheals, intestinal antiinflammatory/antiinfective agents, antiemetic, antiepileptics, antifungals for dermatologiocal use, antigout preparations, antihemorrhagics, antihistamines for systemic use, antihypertensives, antiinflammatory and antirheumatic products, antimycotics for systemic use, antipruritics, antipsoriatics, antivirals for systemic use, beta blocking agents, blood substitutes and perfusion solutions, cardiac therapy, corticosteroids, cough and cold preparations, diagnostic radiopharmaceuticals, diuretics, thyroid therapy, urologicals, vaccines, psycoleptics, psycoanaleptics, ophthalmologicals, muscle relaxants, drugs used in diabetes. Baseline refers to values from the pivotal studies.

Number of Participants With Suicidal Ideation and Suicidal Behavior as Assessed by the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)

eC-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. Suicidal behavior was defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation was defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent. Baseline refers to the baseline values from the pivotal studies.

Secondary Outcome Measures

Full Information

NCT ID

NCT03107052

First Posted

March 23, 2017

Last Updated

November 6, 2021

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03107052

Brief Title

A Study to Explore the Long-Term Safety and Efficacy of Fremanezumab (TEV-48125) for the Prevention of Cluster Headache

Acronym

ENFORCE

Official Title

A Multicenter, Double-Blind, Double-Dummy Study to Explore the Long-Term Safety and Efficacy of TEV-48125 for the Prevention of Cluster Headache

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Terminated

Why Stopped

The study was terminated after the episodic cluster study was terminated due to a pre specified futility analyses

Study Start Date

April 27, 2017 (Actual)

Primary Completion Date

June 11, 2019 (Actual)

Study Completion Date

June 11, 2019 (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 68-week study to evaluate the long-term safety and efficacy of fremanezumab in participants with cluster headache (CH). Participants who complete the pivotal studies TV48125-CNS-30056 (NCT02945046) and TV48125-CNS-30057 (NCT02964338) and enroll into the current study will visit the investigational center for investigational medicinal product (IMP) administration, safety and efficacy assessments, and blood and urine collections for pharmacokinetics, immunogenicity (anti-drug antibodies [ADAs]), and biomarker analyses. Participants will return to the investigational center for a follow-up visit to evaluate ADAs, fremanezumab concentrations, biomarkers, and safety (adverse events and concomitant medications) approximately 7.5 months after the last dose of IMP.

6. Conditions and Keywords

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

Cluster Headache

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

275 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fremanezumab 225 mg Monthly

Arm Type

Experimental

Arm Description

Arm Title

Fremanezumab 675/225 mg Monthly

Arm Type

Experimental

Arm Description

Arm Title

Fremanezumab 675 mg Quarterly

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Fremanezumab

Other Intervention Name(s)

TEV-48125

Intervention Description

Fremanezumab

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events (AEs)

Description

Time Frame

Baseline up to follow-up (Week 68)

Title

Number of Participants With Potentially Clinically Significant Abnormal Laboratory Results: Serum Chemistry

Description

Time Frame

Baseline up to end of treatment (Week 40)

Title

Number of Participants With Potentially Clinically Significant Abnormal Laboratory Results: Hematology

Description

Time Frame

Baseline up to end of treatment (Week 40)

Title

Number of Participants With Potentially Clinically Significant Abnormal Laboratory Results: Urinalysis

Description

Time Frame

Baseline up to end of treatment (Week 40)

Title

Number of Participants With Shift From Baseline to Endpoint (Last Assessment) in Coagulation Laboratory Test Results

Description

Time Frame

Baseline up to end of treatment (Week 40)

Title

Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values

Description

Time Frame

Baseline up to follow-up (Week 68)

Title

Number of Participants With Shift From Baseline to Endpoint (Last Assessment) in Electrocardiogram (ECG) Parameters

Description

Time Frame

Baseline up to follow-up (Week 68)

Title

Number of Participants With Abnormal Physical Examination Findings

Description

Time Frame

Baseline up to follow-up (Week 68)

Title

Number of Participants With Injection Site Reactions

Description

Time Frame

Baseline up to Week 36

Title

Number of Participants With Hypersensitivity/Anaphylaxis Reactions

Description

A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Baseline refers to the baseline values from the pivotal studies.

Time Frame

Baseline up to Week 36

Title

Number of Participants Who Received Concomitant Medications

Description

Time Frame

Baseline up to follow-up (Week 68)

Title

Number of Participants With Suicidal Ideation and Suicidal Behavior as Assessed by the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)

Description

Time Frame

Baseline up to follow-up (Week 68)

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 completes either the Phase 3 pivotal study for ECH (Study TV48125-CNS-30056) or the Phase 3 pivotal study for CCH (Study TV48125-CNS-30057) without important protocol deviations related to participant safety and participant compliance. Prior to 15 June 2018, participants from the ECH study and the CCH study were enrolled. After 15 June 2018, only participants who participated in the ECH study (Study TV48125-CNS-30056) will be enrolled for active treatment. In addition, participants who do not complete the pivotal efficacy studies, and participants who complete the pivotal efficacy studies but will not continue treatment during this long-term safety study, will be offered to enroll in this study for the purpose of evaluating ADAs, and safety (adverse events and concomitant medications) approximately 7.5 months after administration of the last dose of the IMP. Additional criteria apply, please contact the investigator for more information Exclusion Criteria: Any finding that, in the judgment of the investigator, is a clinically significant abnormality, including serum chemistry, hematology, coagulation, and urinalysis test values (abnormal tests may be repeated for confirmation) 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 13834

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85018

Country

United States

Facility Name

Teva Investigational Site 13819

City

Canoga Park

State/Province

California

ZIP/Postal Code

91303

Country

United States

Facility Name

Teva Investigational Site 13811

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Teva Investigational Site 13823

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Teva Investigational Site 13837

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Teva Investigational Site 13814

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80918

Country

United States

Facility Name

Teva Investigational Site 13836

City

Denver

State/Province

Colorado

ZIP/Postal Code

80218

Country

United States

Facility Name

Teva Investigational Site 13813

City

Englewood

State/Province

Colorado

ZIP/Postal Code

80113

Country

United States

Facility Name

Teva Investigational Site 13821

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510-2483

Country

United States

Facility Name

Teva Investigational Site 13812

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06905

Country

United States

Facility Name

Teva Investigational Site 13810

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607

Country

United States

Facility Name

Teva Investigational Site 13815

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Teva Investigational Site 13829

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Teva Investigational Site 13830

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33709

Country

United States

Facility Name

Teva Investigational Site 13842

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Teva Investigational Site 13840

City

Tampa

State/Province

Florida

ZIP/Postal Code

33634

Country

United States

Facility Name

Teva Investigational Site 13833

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

Country

United States

Facility Name

Teva Investigational Site 13826

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60614

Country

United States

Facility Name

Teva Investigational Site 13818

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48104

Country

United States

Facility Name

Teva Investigational Site 13835

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Facility Name

Teva Investigational Site 13832

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89113

Country

United States

Facility Name

Teva Investigational Site 13831

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Teva Investigational Site 13820

City

Princeton

State/Province

New Jersey

ZIP/Postal Code

08540

Country

United States

Facility Name

Teva Investigational Site 13827

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

Teva Investigational Site 13816

City

Amherst

State/Province

New York

ZIP/Postal Code

14226

Country

United States

Facility Name

Teva Investigational Site 13817

City

New York

State/Province

New York

ZIP/Postal Code

10019

Country

United States

Facility Name

Teva Investigational Site 13809

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Facility Name

Teva Investigational Site 13839

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

Teva Investigational Site 13825

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Teva Investigational Site 13824

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Teva Investigational Site 13841

City

Richmond

State/Province

Texas

ZIP/Postal Code

77307

Country

United States

Facility Name

Teva Investigational Site 13822

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23454

Country

United States

Facility Name

Teva Investigational Site 78120

City

Auchenflower

ZIP/Postal Code

4066

Country

Australia

Facility Name

Teva Investigational Site 78118

City

Clayton

ZIP/Postal Code

3168

Country

Australia

Facility Name

Teva Investigational Site 78123

City

Melbourne

ZIP/Postal Code

3004

Country

Australia

Facility Name

Teva Investigational Site 78122

City

Parkville

ZIP/Postal Code

3050

Country

Australia

Facility Name

Teva Investigational Site 78121

City

Randwick

ZIP/Postal Code

2031

Country

Australia

Facility Name

Teva Investigational Site 11132

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y5G8

Country

Canada

Facility Name

Teva Investigational Site 11130

City

Calgary

Country

Canada

Facility Name

Teva Investigational Site 40030

City

Helsinki

ZIP/Postal Code

00180

Country

Finland

Facility Name

Teva Investigational Site 40031

City

Oulu

ZIP/Postal Code

90100

Country

Finland

Facility Name

Teva Investigational Site 40029

City

Turku

ZIP/Postal Code

20100

Country

Finland

Facility Name

Teva Investigational Site 32666

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Teva Investigational Site 32667

City

Bochum

ZIP/Postal Code

44787

Country

Germany

Facility Name

Teva Investigational Site 32660

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Teva Investigational Site 32665

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Teva Investigational Site 32662

City

Kiel

ZIP/Postal Code

24149

Country

Germany

Facility Name

Teva Investigational Site 32661

City

Konigstein im Taunus

ZIP/Postal Code

61462

Country

Germany

Facility Name

Teva Investigational Site 32663

City

Rostock

ZIP/Postal Code

18147

Country

Germany

Facility Name

Teva Investigational Site 80124

City

Ashkelon

ZIP/Postal Code

7830604

Country

Israel

Facility Name

Teva Investigational Site 80122

City

Hadera

ZIP/Postal Code

3810101

Country

Israel

Facility Name

Teva Investigational Site 80125

City

Holon

ZIP/Postal Code

58100

Country

Israel

Facility Name

Teva Investigational Site 80121

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Facility Name

Teva Investigational Site 80123

City

Netanya

ZIP/Postal Code

4244916

Country

Israel

Facility Name

Teva Investigational Site 80120

City

Ramat Gan

ZIP/Postal Code

5265601

Country

Israel

Facility Name

Teva Investigational Site 80127

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Teva Investigational Site 80126

City

Tel-Aviv

ZIP/Postal Code

6812509

Country

Israel

Facility Name

Teva Investigational Site 30190

City

Milan

ZIP/Postal Code

20133

Country

Italy

Facility Name

Teva Investigational Site 30192

City

Modena

ZIP/Postal Code

41124

Country

Italy

Facility Name

Teva Investigational Site 30194

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Teva Investigational Site 30193

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Teva Investigational Site 30191

City

Rome

ZIP/Postal Code

00161

Country

Italy

Facility Name

Teva Investigational Site 30189

City

Rome

ZIP/Postal Code

00163

Country

Italy

Facility Name

Teva Investigational Site 38118

City

Leiden

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

Teva Investigational Site 38119

City

Nijmegen

ZIP/Postal Code

6532 SZ

Country

Netherlands

Facility Name

Teva Investigational Site 38117

City

Zwolle

ZIP/Postal Code

8025 AB

Country

Netherlands

Facility Name

Teva Investigational Site 53380

City

Bialystok

ZIP/Postal Code

15-402

Country

Poland

Facility Name

Teva Investigational Site 53383

City

Krakow

ZIP/Postal Code

31-505

Country

Poland

Facility Name

Teva Investigational Site 53379

City

Krakow

ZIP/Postal Code

33-332

Country

Poland

Facility Name

Teva Investigational Site 53382

City

Lodz

ZIP/Postal Code

90-338

Country

Poland

Facility Name

Teva Investigational Site 53381

City

Szczecin

ZIP/Postal Code

70-111

Country

Poland

Facility Name

Teva Investigational Site 31211

City

Galdakao.

ZIP/Postal Code

48960

Country

Spain

Facility Name

Teva Investigational Site 31214

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Teva Investigational Site 31213

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Teva Investigational Site 31212

City

Valladolid

ZIP/Postal Code

47003

Country

Spain

Facility Name

Teva Investigational Site 31215

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Teva Investigational Site 42047

City

Huddinge

ZIP/Postal Code

141 86

Country

Sweden

Facility Name

Teva Investigational Site 42045

City

Vallingby

ZIP/Postal Code

162 68

Country

Sweden

Facility Name

Teva Investigational Site 34224

City

Glasgow

ZIP/Postal Code

G51 4TF

Country

United Kingdom

Facility Name

Teva Investigational Site 34222

City

Liverpool

ZIP/Postal Code

L9 7LJ

Country

United Kingdom

Facility Name

Teva Investigational Site 34223

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

Teva Investigational Site 34220

City

London

ZIP/Postal Code

W6 8RF

Country

United Kingdom

Facility Name

Teva Investigational Site 34221

City

Oxford

ZIP/Postal Code

OX3 9DU

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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A Study to Explore the Long-Term Safety and Efficacy of Fremanezumab (TEV-48125) for the Prevention of Cluster Headache

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A Study to Explore the Long-Term Safety and Efficacy of Fremanezumab (TEV-48125) for the Prevention of Cluster Headache (ENFORCE)

Cluster Headache

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

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