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)

Phase 1

• Conditions: chronic cluster headache; MedDRA version: 21.1Level: LLTClassification code 10009698Term: Cluster headachesSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-004399-16-DE
• Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-23
• Last Update Posted: 13 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 118

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 of age upon entry into screening.
3)Documented history of chronic cluster headache for =12 months prior to screening according to
the International Classification of Headache Disorders-3rd Edition (ICHD-3)
4)Insufficient efficacy OR tolerability OR contraindications of approved cluster headache
prophylactic medications. Insufficient efficacy and tolerability as determined by the patient.
5)Sufficient acute attack treatment with triptans or oxygen based on the patient´s history
6)The patient is able to distinguish cluster headache attacks from other headaches (i.e. tension-type headaches).

During Baseline:
6)This inclusion criteria should not be shared with potential patients:
At least 9 cluster headache attacks as defined by the ICHD-3 in 7 days during the baseline epoch (SPII),
confirmed by patient-reported eDiary entries.
Attacks must have occurred on more than 50% of days of the baseline epoch (SPII).

7)= 90% patient-reported eDiary compliance during the Baseline epoch, compliance is measured
as interacting with e-Diary at least once a day

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 118
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified