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Cluster Headache clinical trials

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NCT ID: NCT04814381 Recruiting - Clinical trials for Refractory Chronic Cluster Headache

Ketamine + Magnesium for Chronic Cluster Headache (KETALGIA)

KETALGIA
Start date: September 15, 2021
Phase: Phase 4
Study type: Interventional

Chronic cluster headache (CCH) is a rare primary headache disorder, defined by episodic attacks that occur for more than one year with no remission period or with remission periods lasting < 3 months (ICHD-3 criteria). In certain cases, CCH patients become drug-resistant and continue to suffer almost daily attacks. Ketamine appears to be effective in a variety of chronic pain conditions, such as refractory headache, and can show an enhanced analgesic effect when combined with magnesium. A single infusion of ketamine-magnesium combination has been described to reduce attacks in 17 patients with rCCH. The main outcome was a comparison of the number of daily attacks two weeks prior to the infusion and one week after (days 7-8). The number of daily attacks decreased from 4.3±2.4 before treatment to 1.3±1.0 after treatment (p<0.001). 13/17 had at least 50% response. Thus, the goal of this placebo-controlled study is to try to confirm these findings.

NCT ID: NCT04570475 Recruiting - Cluster Headache Clinical Trials

High Dose Vitamin D Plus Multivitamin in the Prevention of Cluster Headache

Start date: September 15, 2021
Phase: Phase 3
Study type: Interventional

This study intends to investigate the use of high-dose Vitamin D3 plus a multivitamin in the prevention of cluster headache attacks. Participants can be enrolled anywhere in the United States that has access to one of our participating labs (for blood work - anticipated to be available in most of the USA). The study may include: - Screening: Participants may be interviewed, examined, fill out surveys, and get blood testing - Week 1: baseline period (no added medications - to establish a baseline) - Weeks 2-4: double-blinded experimental period - participants receive either 1) high-dose Vitamin D3 + multivitamin, or 2) placebo + multivitamin. Participants also fill out a survey and have blood testing. - Weeks 5-7: open-label period - ALL participants receive high-dose Vitamin D3 + multivitamin. Participants also fill out a survey and may have blood testing. Specifically, our primary outcome is the change from baseline to experimental weeks 1-3 in the frequency of cluster headache attacks between placebo and high-dose vitamin D. Specific primary and secondary outcomes are listed below.

NCT ID: NCT04467398 Recruiting - Clinical trials for Trigeminal Neuralgia

Incidence of Intravascular (IV) Injection During Trigeminal Nerve Blocks

Start date: July 20, 2020
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to investigate the incidence of intravascular injection during trigeminal nerve blocks.

NCT ID: NCT04409977 Recruiting - Cluster Headache Clinical Trials

Circadian Changes of the Hypothalamic Activity in Patients Suffering From Cluster Headache

Start date: June 26, 2019
Phase:
Study type: Observational

Cluster headache attacks do not occur randomly throughout the day, but have a clear circadian rhythmicity. The aim of this study is to investigate circadian changes of the brain, the autonomic nervous system and pain processing systems.

NCT ID: NCT04406259 Recruiting - Cluster Headache Clinical Trials

Atrioventricular Block and Cluster Headache (SEVA)

SEVA
Start date: November 2, 2020
Phase: Phase 4
Study type: Interventional

Verapamil is a calcium channel blocker widely used to treat cardiovascular diseases however it is also the first line treatment in the prevention of cluster headaches. In France, its prescription in that indication is based on compliance with the Temporary Recommendation for Use (RTU) that insists on the possible the cardiac side effects that can occur as the doses required for cluster headache are significantly higher than the doses used in cardiology.

NCT ID: NCT03944876 Recruiting - Cluster Headache Clinical Trials

Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Cluster Headache

BASIC
Start date: November 1, 2019
Phase: Phase 3
Study type: Interventional

Cluster headache is a primary headache condition characterized by clusters of one-sided, high-intensity pain attacks. The headache may be episodic or chronic. Treatment options are limited and their effects unsatisfactory. An important nerve pathway involved in the pain attacks has a switching station at the sphenopalatine ganglion (SPG) located in the depth of the facial bones. SPG is a known therapy target for cluster headache. The area can be identified on CT images, but is difficult to access due to its location. Thus, the Multiguide navigation system has been developed to enable precise delivery of the drugs that target SPG activity. In Trondheim, two phase 1 / Phase 2 study have been carried out using botulinum toxin A (Botox®) against SPG in patient with chronic cluster headache and chronic migraine. The results indicate that such a treatment strategy is safe and beneficial. The current study is a randomized, placebo-controlled, triple-blinded study to investigate whether precise single-injection of botulinum toxin A reduces the frequency of attacks in chronic cluster headache .

NCT ID: NCT03840928 Recruiting - Obesity Clinical Trials

PatientSpot Formerly Known as ArthritisPower

Start date: April 1, 2015
Phase:
Study type: Observational [Patient Registry]

Patient Power is a patient research network and database (registry) to collect prospective information about demographics, self-reported diagnoses and medications, and willingness to participate in research from participants with rheumatoid arthritis (RA), spondyloarthritis (SpA), other musculoskeletal conditions, chronic neurological conditions like migraine, chronic pulmonary conditions like Chronic Obstructive Pulmonary Disease (COPD), asthma, autoimmune dermatological conditions such as psoriasis, and other chronic inflammatory or immune-mediated conditions. In addition, since patients with chronic conditions often have other co-morbidities like cardiovascular health and obesity-related metabolic disorders, these conditions will also be included. Participants will provide information from their smartphones or personal computers. The information will be used by researchers and clinicians to help patients and their providers make better, more informed decisions about treatment of chronic conditions.

NCT ID: NCT03814226 Recruiting - Cluster Headache Clinical Trials

PACAP-38 Infusion in Patients With Cluster Headache

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

A randomized, double-blinded, two-way crossover study investigating the headache inducing capabilities of PACAP-38 in patients with cluster headache. Forty-five patients (15 episodic patients in cluster, 15, episodic patients in remission and 15 chronic cluster headache patients) are expected to participate. Each patients will on two separate study days in a randomized way receive an infusion of PACAP-38 and VIP over 20 minutes followed by an observation period of 70 minutes. Blood samples for investigation of VIP, PACAP38; CGRP, NSE, Histamine and Tryptase will be drawn at fixed time-points during experiment.

NCT ID: NCT03781128 Recruiting - Cluster Headache Clinical Trials

Lysergic Acid Diethylamide (LSD) as Treatment for Cluster Headache

LCH
Start date: January 2, 2019
Phase: Phase 2
Study type: Interventional

Background: After no official research in humans in the last 40 years, research and therapeutic uses of the serotonergic psychedelic lysergic acid diethylamide (LSD) are now re-recognized and include its use in brain research, alcoholism, anxiety associated with terminal illness, and treatment of headache disorders. Specifically, LSD has been reported to abort attacks, to decrease frequency and intensity of attacks, and to induce remission in patients suffering from cluster headache (CH). Objective: To investigate the effects of an oral LSD pulse regimen (3 x 100 µg LSD in three weeks) in patients suffering from CH compared with placebo. Design: Double-blind, randomized, placebo-controlled two-phase cross-over study design. Participants: 30 patients aged ≥ 25 and ≤ 75 years with chronic or episodic CH with predictable periods lasting approximately 2 months and attacks responding to oxygen. Main outcome measures: Changes in frequency and intensity of CH attacks assessed with a standardized headache diary Significance: CH is often rated as the most painful of all primary headaches, which not only causes significant disability, but is also associated with enormous personal, economic, and psychiatric burden. At the moment, there is no specific treatment available for CH, but serotonergic compounds represent an important drug class, especially in the abortive management of cluster attacks. However, there is a need for new treatment approaches, as CH is also often insufficiently managed with available medication. This study will evaluate the potential benefit and safety of a treatment with LSD for patients with CH.

NCT ID: NCT02910323 Recruiting - Clinical trials for Trigeminal Neuralgia

The Will Erwin Headache Research Center - Cluster Headache Study

WEC1
Start date: May 2016
Phase:
Study type: Observational

The Will Erwin Headache Research Center Study of Cluster Headache and Trigeminal Neuralgia is a prospective, multicenter, observational research network for subjects with Cluster Headache and/or Trigeminal Neuralgia.