Back to results

Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study (APOLLON)

Primary Purpose

Migraine, Migraine Disorders, Migraine Headache

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Erenumab

About this trial

This is an interventional prevention trial for Migraine focused on measuring migraine, episodic migraine, headache, erenumab, AMG334, aimovig, monoclonal antibody, CGRP-receptor antibody

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Key inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study
Patient is capable of understanding the nature, significance and implications of the clinical trial.
Adults ≥18 years of age upon entry into screening

Key exclusion Criteria:

Use of a prophylactic migraine medication within five plasma clearance half-lives, or a device or procedure within one month prior to the start of the Open-label Treatment Epoch. This exclusion criteria does not apply to erenumab or topiramate administered within clinical trial CAMG334ADE01
Any prior exposure to (investigational) prophylactic migraine products targeting the CGRP pathway, other than erenumab.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Erenumab

Arm Description

70 mg and 140 mg Erenumab

Outcomes

Primary Outcome Measures

Exposure adjusted incidence rate of AE during Open-label Treatment Epoch per 100 subject years

To evaluate the long-term safety of 70 and 140 mg erenumab

Secondary Outcome Measures

Proportion of patients discontinuing open-label Treatment Epoch due to AE

To evaluate the long-term tolerability of 70 and 140 mg erenumab

Proportion of patients discontinuing open-label Treatment Epoch due to non-AE reasons

To evaluate the long-term tolerability of 70 and 140 mg erenumab in patients with episodic migraine.

Full Information

NCT ID

NCT04084314

First Posted

September 6, 2019

Last Updated

April 16, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04084314

Brief Title

Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study

Acronym

APOLLON

Official Title

Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

September 30, 2019 (Actual)

Primary Completion Date

February 23, 2023 (Actual)

Study Completion Date

March 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

This is a 128-week open-label study to assess the long-term safety and tolerabilty of the monoclonal antibody erenumab.

Detailed Description

The regular assessments in a controlled trial allows a close observation of safety parameters during long-term treatment with erenumab. This 128-week open-label study will provide further treatment to patients of the study CAMG334ADE01 (Eudract number:2019-002201-22) and will provide data about the long-term safety and tolerability of erenumab and patients' quality of life during long-term treatment. Besides options to adjust the dose, an optional drug holiday is included in this open-label study and the effects of a treatment interruption on safety, tolerability, efficacy and quality of life will be investigated.

6. Conditions and Keywords

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

Migraine, Migraine Disorders, Migraine Headache

Keywords

migraine, episodic migraine, headache, erenumab, AMG334, aimovig, monoclonal antibody, CGRP-receptor antibody

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

700 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Erenumab

Arm Type

Experimental

Arm Description

70 mg and 140 mg Erenumab

Intervention Type

Biological

Intervention Name(s)

Erenumab

Other Intervention Name(s)

AMG334; Aimovig

Intervention Description

pre-filled pen (auto-injector)

Primary Outcome Measure Information:

Title

Exposure adjusted incidence rate of AE during Open-label Treatment Epoch per 100 subject years

Description

To evaluate the long-term safety of 70 and 140 mg erenumab

Time Frame

128 weeks

Secondary Outcome Measure Information:

Title

Proportion of patients discontinuing open-label Treatment Epoch due to AE

Description

To evaluate the long-term tolerability of 70 and 140 mg erenumab

Time Frame

128 weeks

Title

Proportion of patients discontinuing open-label Treatment Epoch due to non-AE reasons

Description

To evaluate the long-term tolerability of 70 and 140 mg erenumab in patients with episodic migraine.

Time Frame

128 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key inclusion Criteria: Signed informed consent must be obtained prior to participation in the study Patient is capable of understanding the nature, significance and implications of the clinical trial. Adults ≥18 years of age upon entry into screening Key exclusion Criteria: Use of a prophylactic migraine medication within five plasma clearance half-lives, or a device or procedure within one month prior to the start of the Open-label Treatment Epoch. This exclusion criteria does not apply to erenumab or topiramate administered within clinical trial CAMG334ADE01 Any prior exposure to (investigational) prophylactic migraine products targeting the CGRP pathway, other than erenumab.

Facility Information:

Facility Name

Novartis Investigative Site

City

Stuttgart

State/Province

Baden Wuertemberg

ZIP/Postal Code

70178

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30159

Country

Germany

Facility Name

Novartis Investigative Site

City

Aachen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

52062

Country

Germany

Facility Name

Novartis Investigative Site

City

Alzenau

ZIP/Postal Code

63755

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Homburg

ZIP/Postal Code

61348

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Honnef

ZIP/Postal Code

53604

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Saarow

ZIP/Postal Code

15526

Country

Germany

Facility Name

Novartis Investigative Site

City

Bayreuth

ZIP/Postal Code

95445

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10713

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

120999

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12101

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12163

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12627

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13053

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

14169

Country

Germany

Facility Name

Novartis Investigative Site

City

Bielefeld

ZIP/Postal Code

D 33647

Country

Germany

Facility Name

Novartis Investigative Site

City

Boblingen

ZIP/Postal Code

71032

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Facility Name

Novartis Investigative Site

City

Bonn

ZIP/Postal Code

53111

Country

Germany

Facility Name

Novartis Investigative Site

City

Bonn

ZIP/Postal Code

53177

Country

Germany

Facility Name

Novartis Investigative Site

City

Chemnitz

ZIP/Postal Code

09117

Country

Germany

Facility Name

Novartis Investigative Site

City

Dillingen

ZIP/Postal Code

66763

Country

Germany

Facility Name

Novartis Investigative Site

City

Erbach

ZIP/Postal Code

64711

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45133

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60313

Country

Germany

Facility Name

Novartis Investigative Site

City

Freiburg

ZIP/Postal Code

79098

Country

Germany

Facility Name

Novartis Investigative Site

City

Gelsenkirchen

ZIP/Postal Code

45879

Country

Germany

Facility Name

Novartis Investigative Site

City

Greifswald

ZIP/Postal Code

17475

Country

Germany

Facility Name

Novartis Investigative Site

City

Haar

ZIP/Postal Code

85540

Country

Germany

Facility Name

Novartis Investigative Site

City

Halle

ZIP/Postal Code

06120

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20253

Country

Germany

Facility Name

Novartis Investigative Site

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Novartis Investigative Site

City

Hoppegarten

ZIP/Postal Code

15366

Country

Germany

Facility Name

Novartis Investigative Site

City

Ibbenbueren

ZIP/Postal Code

49477

Country

Germany

Facility Name

Novartis Investigative Site

City

Jena

ZIP/Postal Code

07740

Country

Germany

Facility Name

Novartis Investigative Site

City

Juelich

ZIP/Postal Code

52428

Country

Germany

Facility Name

Novartis Investigative Site

City

Kassel

ZIP/Postal Code

34121

Country

Germany

Facility Name

Novartis Investigative Site

City

Kiel

ZIP/Postal Code

24149

Country

Germany

Facility Name

Novartis Investigative Site

City

Koln

ZIP/Postal Code

50935

Country

Germany

Facility Name

Novartis Investigative Site

City

Königstein im Taunus

ZIP/Postal Code

61462

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04107

Country

Germany

Facility Name

Novartis Investigative Site

City

Luenen

ZIP/Postal Code

44534

Country

Germany

Facility Name

Novartis Investigative Site

City

Mannheim

ZIP/Postal Code

66163

Country

Germany

Facility Name

Novartis Investigative Site

City

Marburg Wehrda

ZIP/Postal Code

35041

Country

Germany

Facility Name

Novartis Investigative Site

City

Mittweida

ZIP/Postal Code

09648

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

81377

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

81675

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Novartis Investigative Site

City

Neu-Ulm

ZIP/Postal Code

89231

Country

Germany

Facility Name

Novartis Investigative Site

City

Neuburg an der Donau

ZIP/Postal Code

86633

Country

Germany

Facility Name

Novartis Investigative Site

City

Osnabrück

ZIP/Postal Code

49074

Country

Germany

Facility Name

Novartis Investigative Site

City

Pforzheim

ZIP/Postal Code

75172

Country

Germany

Facility Name

Novartis Investigative Site

City

Quakenbrueck

ZIP/Postal Code

49610

Country

Germany

Facility Name

Novartis Investigative Site

City

Regensburg

ZIP/Postal Code

93059

Country

Germany

Facility Name

Novartis Investigative Site

City

Rostock

ZIP/Postal Code

18057

Country

Germany

Facility Name

Novartis Investigative Site

City

Ruelzheim

ZIP/Postal Code

76761

Country

Germany

Facility Name

Novartis Investigative Site

City

Schwerin

ZIP/Postal Code

19053

Country

Germany

Facility Name

Novartis Investigative Site

City

Schwerin

ZIP/Postal Code

19055

Country

Germany

Facility Name

Novartis Investigative Site

City

Seesen

ZIP/Postal Code

38723

Country

Germany

Facility Name

Novartis Investigative Site

City

Siegen

ZIP/Postal Code

57076

Country

Germany

Facility Name

Novartis Investigative Site

City

Sindelfingen

ZIP/Postal Code

71065

Country

Germany

Facility Name

Novartis Investigative Site

City

Stadtroda

ZIP/Postal Code

07646

Country

Germany

Facility Name

Novartis Investigative Site

City

Stuttgart

ZIP/Postal Code

70174

Country

Germany

Facility Name

Novartis Investigative Site

City

Stuttgart

ZIP/Postal Code

70178

Country

Germany

Facility Name

Novartis Investigative Site

City

Stuttgart

ZIP/Postal Code

70182

Country

Germany

Facility Name

Novartis Investigative Site

City

Trier

ZIP/Postal Code

54292

Country

Germany

Facility Name

Novartis Investigative Site

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Novartis Investigative Site

City

Ulm

ZIP/Postal Code

89073

Country

Germany

Facility Name

Novartis Investigative Site

City

Unterhaching

ZIP/Postal Code

82008

Country

Germany

Facility Name

Novartis Investigative Site

City

Westerstede/Oldenburg

ZIP/Postal Code

26655

Country

Germany

Facility Name

Novartis Investigative Site

City

Wiesbaden

ZIP/Postal Code

65191

Country

Germany

Facility Name

Novartis Investigative Site

City

Wuerzburg

ZIP/Postal Code

97080

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study

We'll reach out to this number within 24 hrs

Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study (APOLLON)

Migraine, Migraine Disorders, Migraine Headache

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

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