Efficacy of Erenumab in the preventive treatement of chronic cluster headache (painful headache attacks): A 10 week clinical trial, which will be performed at multiple (=multicentric) trial centers (e.g. hospitals, doctors office). Patients will be assigned / allocated on random basis (=randomization) to either the experimental group (Erenumab) or control group (Placebo). Neither the patient nor the treating physician knows if the patient receives Erenumab or Placebo (double-blind)

Efficacy of erenumab in chronic cluster headache: A 10-week double-blind, randomized, placebo-controlled, multicentric trial - CAMG334ADE07T

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004399-16-DE

Enrollment

118

Registered

2021-02-23

Start date

2021-04-28

Completion date

Unknown

Last updated

2021-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic cluster headache MedDRA version: 21.1 Level: LLT Classification code 10009698 Term: Cluster headaches System Organ Class: 100000004852

Interventions

Trade Name: Aimovig Pharmaceutical Form: Injection Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Subcutaneous use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: During Screening: 1) Patient is capable of understanding the nature, significance and implications of the clinical trial . Written informed consent must be obtained before any assessment is performed 2) Adult’s =18 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Diagnosis or history of other primary headache diseases including the diagnosis of episodic cluster headache according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3), excluding episodic tension type headache. Use of a prophylactic cluster headache prophylaxis medication within 5 half-lives prior to the start of the baseline phase. (specified in Table 5.1) Parallel use of an SPG stimulator or parallel use of a device for the acute/preventive treatment of cCH; Significant comorbidities or psychiatric disorders, drug abuse or opioid use Diagnosis or history of severe psychiatric or personality disorder Concurrent use of other therapeutic monoclonal antibodies Diagnosis of chronic or active hepatitis

Design outcomes

Primary

Measure	Time frame
Secondary Objective: 1. To evaluate the effect of erenumab compared to placebo on the proportion of patients with at least a 50% reduction from baseline in weekly CH attacks at week 5 and 6 (days 29-42). 2. To evaluate the effect of erenumab compared to placebo on the change from baseline in the GPI-Scale at week 6 ;Main Objective: The primary objective of this study is to test the hypothesis that erenumab is superior to placebo in the reduction of weekly CH attacks in weeks 5 and 6 (days 29-42) in the erenumab group compared to placebo versus baseline;Primary end point(s): Reduction from baseline (averaged per 7 days) in weekly CH attacks averaged for 7 days over the last 2 weeks (days 29-42) of the double-blind epoch;Timepoint(s) of evaluation of this end point: Weeks 5-6	—

Measure

Time frame

Secondary Objective: 1. To evaluate the effect of erenumab compared to placebo on the proportion of patients with at least a 50% reduction from baseline in weekly CH attacks at week 5 and 6 (days 29-42). 2. To evaluate the effect of erenumab compared to placebo on the change from baseline in the GPI-Scale at week 6 ;Main Objective: The primary objective of this study is to test the hypothesis that erenumab is superior to placebo in the reduction of weekly CH attacks in weeks 5 and 6 (days 29-42) in the erenumab group compared to placebo versus baseline;Primary end point(s): Reduction from baseline (averaged per 7 days) in weekly CH attacks averaged for 7 days over the last 2 weeks (days 29-42) of the double-blind epoch;Timepoint(s) of evaluation of this end point: Weeks 5-6

—

Secondary

Measure	Time frame
Secondary end point(s): 1.) Number of patients achieving at least a 50% reduction from baseline in weekly CH attacks averaged over the last 2 weeks (days 29-42) of the double-blind epoch. 2.) Patient Global Impression of Improvement (PGI-I) at week 6 (day 42).;Timepoint(s) of evaluation of this end point: 1.) Week 5-6 2.) Week 6	—

Countries

Germany

Contacts

Public ContactProjectmanager

Charité - Universitätsmedizin Berlin

ma.lorenz@charite.de+4930450 560 275

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026