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Cluster Headache clinical trials

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NCT ID: NCT05477459 Not yet recruiting - Clinical trials for Chronic Cluster Headache

LSD to Improve Cluster Headache Impact Trial

LICIT
Start date: January 2024
Phase: Phase 2
Study type: Interventional

This study aims to investigate the efficacy and safety of LSD 25μg every 3 days for 3 weeks versus placebo in the treatment of chronic cluster headache (cCH). It is a 3-week double-blind placebo-controlled intervention study, preceded by a 4-week baseline observation period and followed by a 5-week post-treatment observation period. Primary objective: to evaluate the efficacy of LSD 25μg every 3 days for 3 weeks in cCH. Additional objectives: - To evaluate the safety of LSD 25μg every 3 days for 3 weeks in cCH. - To explore the exposure-response relationship of 25μg LSD in cCH. - To assess the effect of treatment with 25μg LSD on hypothalamic functional connectivity in patients with cCH, using resting state functional magnetic resonance imaging (rsMRI). - To explore cost-effectiveness of treatment with LSD in cCH. - To evaluate the efficacy of LSD on health-related quality of life.

NCT ID: NCT05324748 Recruiting - Cluster Headache Clinical Trials

Repeated GON Injections in CCH

REGON
Start date: November 7, 2022
Phase: Phase 3
Study type: Interventional

Background: - The effect of repeated GON-injections has never been studied in a double-blind randomized trial as a prophylactic therapy in a well-documented group of chronic patients. As such, (repeated) GON-injection has not yet found its place in current (inter)national treatment protocols for chronic cluster headache. Objectives: - The primary objective is to determine if repeated GON-injection result in effective control of cluster headache attacks for more days compared to placebo in chronic cluster headache. Eligibility: - Patients will be selected from the LUMC (Leiden University Medical Center) and CWZ (Canisius Wilhelmina Hospital) chronic cluster headache populations, diagnosed based upon the ICHD-3. Design: - Bi-centre, randomized, double-blind, placebo-controlled retention trial with a maximum follow-up of one year.

NCT ID: NCT05264714 Recruiting - Cluster Headache Clinical Trials

Cluster Headache Treatment With Rimegepant

Start date: September 7, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this research is to explore the efficacy of rimegepant as a preventative therapy for cluster headache.

NCT ID: NCT05153876 Completed - Migraine Disorders Clinical Trials

An Open Internet-based Survey and Natural Language Processing Project Analysing Written Monologues by Headache Patients

NLPH-OPEN
Start date: October 11, 2021
Phase:
Study type: Observational

Headache disorders are among the most prevalent medical conditions worldwide. The diagnosis of headache disorders is based on medical history taking. Digital solutions such as natural language processing (NLP) may be of aid to understand the linguistic aspects of headache attack and headache related disability descriptions by patients. Participants will provide a written description of their headache disorder. The results will hopefully lead to a better understanding of the potential use of NLP in headache disorders.

NCT ID: NCT05093582 Completed - Cluster Headache Clinical Trials

The Effects of Levcromakalim in Patients With Cluster Headache

Start date: June 4, 2021
Phase: N/A
Study type: Interventional

Cluster headache is a primary headache disorder characterized by attacks of unilateral headache of short duration and severe pain intensity. There is an unmet need to understand the underlying disease mechanisms that will ultimately lead to the development of disease-specific medicines. Until now, it has been suggested that the calcitonin gene-related peptide (CGRP) plays a major role in the initiation of a cluster headache attack, possibly involving the ATP-sensitive potassium channels. The current study aims to determine whether the opening of ATP-sensitive potassium channels triggers cluster headache attacks in patients with cluster headache.

NCT ID: NCT05084469 Not yet recruiting - Clinical trials for Cluster Headache, Episodic

Exploration of Cluster Headache in a PET-MRI Study

F13640-AVF
Start date: November 1, 2021
Phase:
Study type: Observational

Observational study in PET-MRI using the 5-HT1A agonist PET radiotracer [18F]F13640.

NCT ID: NCT05064397 Completed - Clinical trials for Chronic Cluster Headache

A 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH)

CHRONICLE
Start date: September 17, 2021
Phase: Phase 3
Study type: Interventional

The main goal of this trial is to inform about long-term safety and tolerability of eptinezumab in participants with chronic cluster headache.

NCT ID: NCT05023460 Active, not recruiting - Pain Clinical Trials

Treatment of Chronic Cluster Headache With TENS and ONS

HortONS
Start date: August 27, 2021
Phase: N/A
Study type: Interventional

The study is an investigator-initiated, prospective, randomized, placebo-controlled, double blind clinical trial that aims to investigate the effect of transcutaneous electrical nerve stimulation (TENS) and occipital nerve stimulation (ONS) on attack frequency and severity in patients with chronic cluster headache (CH). Study outline Month 1: Baseline. Establishment of a baseline profile of the participants CH attacks (severity, duration, medicine utilization etc), health-related quality of life (QoL) and symptoms of anxiety and depression. No active treatment. Follow-up visit after 30 days. Months 2-4: TENS period. All participants will receive TENS-treatment. Clinical follow-up visit by the end of month four. Months 5-7: Double-blinded, randomized experimental period. All participants will have an ONS-system (lead, impulse generator) implanted and will be randomized 1:1 to receive either 1) burst (paresthesia-free) ONS or 2) placebo (deactivated ONS system). Clinical follow-up visit by the end of month seven. Months 8-10: Open label period. All participants will receive tonic (conventional, paresthesia-inducing) ONS. Clinical follow-up visit by the end of month ten. During every study phase each participant will fill out a weekly electronic headache registration as well as answering questionnaires regarding health-related quality of life and symptoms of anxiety and depression before every follow-up visit.

NCT ID: NCT04983186 Completed - Migraine Clinical Trials

mBrain-21 : a Three-month Study on Context-awareness, Physiological Monitoring, and Machine Learning in Migraine and Cluster Headache

MBRAIN-21
Start date: July 19, 2021
Phase: N/A
Study type: Interventional

This study collects data from migraine and cluster headache patients during a three-month study. Contextual data (e.g. location or smartphone usage) and physiological variables will be used to assist machine learning algorithms in making predictions on activity, stress and sleep in patients with migraine or cluster headache.

NCT ID: NCT04970355 Completed - Cluster Headache Clinical Trials

Efficacy of Erenumab in Chronic Cluster Headache

CHERUB01
Start date: December 2, 2021
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate the efficacy of erenumab in participants with chronic cluster headache.