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Headache clinical trials

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NCT ID: NCT02640105 Completed - Cluster Headache Clinical Trials

Cluster Headache, Addictions and Vascular Function

CHAD
Start date: June 25, 2014
Phase:
Study type: Observational [Patient Registry]

Cluster headache (CH) is one of the most painful primitive headaches. Developments in neuroimaging have demonstrated activation of the ipsilateral hypothalamic and orexinergic system, which is similar in patients with addictions. CH has strong links to the vascular system but there is no study measuring endothelial function in CH sufferers.

NCT ID: NCT02638506 Terminated - Headaches Clinical Trials

RCT Evaluating Intranasal Fentanyl in the Pain Management of Children With Headaches

Start date: January 2016
Phase: Phase 4
Study type: Interventional

Background : Headaches are a common presentation for children consulting to the Emergency Department (ED). However, only few studies have evaluated the rapid pain improvement provided by medications in the acute management of headaches in the pediatric population. Objective : To evaluate pain reduction provided by intranasal fentanyl (INF) compared to placebo in addition to ibuprofen for children presenting to a pediatric ED with moderate to severe headaches. Methods : A single-center, double-blind, randomized, placebo controlled clinical trial will be conducted in an urban, university-affiliated, tertiary care pediatric hospital ED. All children eight to 18 years old who will present to the ED with headaches as a main chief complaint and with pain of ≥ 36 mm out of 100 on Visual Analog Scale (VAS) will be recruited. Study participants will be randomly allocated to receive INF 1.5 mcg/kg (maximum dose of 100 mcg) or similar volume of a placebo solution via an atomizer. Co-administration of oral ibuprofen 10 mg/kg (maximum dose of 600 mg) will also be provided to the two groups if not received in the previous 4 hours. The primary outcome will be the mean pain rating reduction at 15 minutes. The secondary outcomes will be mean pain reduction at 30 and 60 minutes, patient's and parental satisfaction levels, percent of being pain free, sedation score, immediate and within 72 hours adverse events, additional ED analgesics and other medications, length of ED stay, disposition outcomes, hospital admission rate and ED revisit rate within 72 hours. The primary analysis will use an intention-to-treat approach to compare mean pain score reduction between the two groups using a Student's T-test. The sample size of 60 participants per arm was calculated to have a power of 80% to identify a difference of 10 mm in the VAS. Expected results : Our study might demonstrate that INF provides additional pain relief for children presenting to an ED with headaches. Providing INF could relieve their symptoms more quickly, potentially improve patient's and family's satisfaction, possibly reduce the length of their ED stay and consequently, have a significant impact on patient quality of care and cost-effectiveness.

NCT ID: NCT02637648 Not yet recruiting - Cluster Headache Clinical Trials

Sodium Oxybate in Patients With Episodic and Chronic Cluster Headache

SOinCH
Start date: December 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to test the effects of sodium oxybate on headache response (frequency), sleep quality and quality of life in the prophylactic treatment of patients with chronic and episodic cluster headache. Oral sodium oxybate, 3-9g per night, starting with 3g in two nightly dosages of 1.5g and increased by steps of 1.5g every second or third night until treatment Response will be evaluated in an interventional, placebo-controlled, double-blind, randomised, parallel group, multicentre study. Primary outcome is reduction of nocturnal pain frequency Secondary outcomes are improvement of sleep quality at a subjective level as assessed by diary and standardized scales (PSQI, FOSQ), duration of pain free episodes, general clinical outcome (global evaluation), clinical global impression (CGI-S, CGI-I, CGI-E), quality of life (SF 36) and daytime sleepiness (Epworth Sleepiness Score).

NCT ID: NCT02630719 Terminated - Migraine Clinical Trials

Timolol Eye Drops in the Treatment of Acute Migraine Headache

Start date: January 2016
Phase: N/A
Study type: Interventional

The goal of this study is to determine whether timolol eye drops are effective in alleviating acute migraine headaches. Subjects will be randomized to receive either timolol eye drops or placebo (tears) to use as a migraine abortive medication.

NCT ID: NCT02624661 Terminated - Clinical trials for Trigeminal Neuralgia

Glycerol Block of the Trigeminal Ganglion in Trigeminal Neuralgia Using a New Neuronavigation-based Surgical Technique

Start date: May 2016
Phase: Phase 1/Phase 2
Study type: Interventional

Trigeminal neuralgia is one of the strongest pains known to humans. Some patients do not have enough effect with the available pharmaceutical treatments and are offered a type of surgery, which involves the injection of glycerol in a nerve structure called trigeminal ganglion. The researchers will do a pilot study on 10 patients with a new surgical technique using neuronavigation. The researchers believe that this new neuronavigation-based system can improve the precision of the technique and reduce the risk for complications.

NCT ID: NCT02619617 Terminated - Clinical trials for Cluster Headache - Episodic and Chronic

Safety and Efficacy Study of SOM230 s.c. in Cluster Headache

Start date: October 31, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study was to determine if SOM230 is safe and effective for the treament of cluster headache.

NCT ID: NCT02592850 Withdrawn - Clinical trials for Tension-Type Headache

Evidence-Based Osteopathy for Tension-Type Headache (EBOTTH)

EBOTTH
Start date: January 2016
Phase: N/A
Study type: Interventional

Tension-type headache (TTH) is a very common primary headache disorder, with important costs for both patients and society. Often these patients are not willing to take prophylactic medications and resort to complementary therapies. Osteopathic manipulative treatment (OMT) is an interesting option in such field, since it is characterized by a low profile of side effects. In this study the investigators will assess the efficacy of OMT (semi-structured evaluation and "black box" treatment) in frequent Episodic TTH (ETTH) in an outpatient setting. Preliminary data for power calculation are already available (Rolle et al. 2014), and the investigators plan to recruit 264 ETHH patients by a multicentric, randomized, double-blind, sham-controlled design.

NCT ID: NCT02585739 Completed - Clinical trials for Episodic or Chronic Cluster Headache

Cluster Headache and SPINK-1 Gene

Start date: October 2011
Phase: N/A
Study type: Interventional

Cluster headache (CH) is a rare, excruciating primary headache disorder. A genetic basis has been suggested by family and twin studies, but the mode of transmission seems to vary and the amount of heritability is unclear. The number of genetic association studies investigating variants implicated in the pathophysiology of CH is limited. The HCRTR2 1246G > A and the ADH4 925A > G polymorphisms have been associated with CH. The former has been confirmed and may affect the hypothalamic hypocretin system. The aim of the present study was to investigate the possible link between SPINK 1 gene and cluster headache.

NCT ID: NCT02583425 Terminated - Clinical trials for Medication Overuse Headache

Pilot Study of DFN-11 Injection in Medication Overuse Headache

Start date: September 2015
Phase: Phase 2
Study type: Interventional

Efficacy and Safety Pilot Study of DFN-11 Injection in Medication Overuse Headache

NCT ID: NCT02549898 Completed - Clinical trials for Migraine Without Aura

Investigation of Vascular Inflammation in Migraine Using Molecular Nano-imaging and Black Blood Imaging MRI

Start date: August 2015
Phase: N/A
Study type: Interventional

The investigators aim to investigate inflammation of cranial and meningeal arteries during pharmacologically induced migraine attacks, using ultrasmall superparamagnetic iron oxide (USPIO) nanoparticles and black blood imaging (BBI) MRI.