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Headache clinical trials

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NCT ID: NCT04989413 Recruiting - Clinical trials for Chronic Migraine, Headache

Cannabidiol 133mg + Cannabigerol 66mg + Tetrahydrocannabinol 4mg vs Placebo as Adjuvant Treatment in Chronic Migraine -

CAMTREA
Start date: October 18, 2022
Phase: Phase 4
Study type: Interventional

To evaluate the effect of the cannabidiol (CBD) + cannabigerol (CBG) + tetrahydrocannabinol (THC) up to 133/66/4mg daily versus placebo as adjuvant treatment in chronic migraine (CM) patients under preventive treatment at a stable dose for at least 3 months who present at least 5 headaches day a month. CM patients of both sexes, between 25 and 65 years old, who have not had CBD and/or THC as a migraine treatment. Patients may be having migraine preventive treatment such as propranolol, atenolol, topiramate, valproic acid/sodium valproate, levetiracetam, gabapentin, lamotrigine, pre-gabaline, flunarizine, amitriptyline, nortriptyline, clomipramine, candesartan, galcanezumab, erenumab, fremanezumab, botulinum toxin type A. Acute treatment will follow patients doctor's prescription. Exclusion criteria: active liver disease or elevated liver transaminases> 3 times than the normal values, pregnancy, fertile age women without contraceptive treatment or who intend to get pregnant, patients without migraine preventive treatment or that changed the preventive treatment less than 3 months from the study start, substance abuse or addiction, use of medical cannabis or products with CBD or THC in the last 30 days or during study period, history of allergy or adverse reactions with the use of CBD or related products, substance users of liver enzymes inducers such as rifampicin, ketoconazole, theophylline, carbamazepine, phenytoin, phenobarbital and St. John's wort, clobazam, macrolides, verapamil, fluoxetine, amiodarone and tacrolimus. Patients on vitamin K anticoagulant medicines, as warfarin. Randomization using a computacional system will stratify participants in each group by gender (F/M), age (25-34/35-44/45-54/55-65yo), headache days presented in the baseline month (5-10/11-15/16-20/21-25/26-30), overuse medication (yes or no). After randomization patients will be divided into two groups of 55 participants, who will receive CBD + CBG + THC up to a maximum daily dose of 133/66/4 mg or placebo for 12 weeks (V0 screening, V1 allocation, V4 final visit). The main outcome is the reduction in frequency of headache days per 4 weeks between V1 and V4 compared to placebo. Secondary outcomes will be a reduction in duration and intensity of migraine attacks, amount of painkillers used and percentage of patients with a reduction greater than 50% on migraine days, 50% reduction in the other variables as MIDAS scores, HIT-6 scores, Beck's Anxiety and Depression Scales, Epworth Sleepiness Scales, and the scores at The Severity of Dependence Scale used as an indicator of overuse medication in this sample. Clinical data will be registered on a personalized headache diary developed to this study using MyCap, from RedCap System, as an APP for daily entries using smartphones, androids or IOS system. The clinical and laboratory data obtained in this study will comply with the objectives elaborated in the evaluation of the primary and secondary endpoints, the proposal of which is to publish the data regardless of the results obtained.

NCT ID: NCT04939922 Recruiting - Fibromyalgia Clinical Trials

China Headache Registry Study

CHRS
Start date: June 12, 2017
Phase:
Study type: Observational [Patient Registry]

In the Chinese Headache and Vertigo Registration Study, patients aged 4-99 years with headache (primary headache and secondary headache such as migraine and tension type headache), vertigo (vertigo diseases such as vestibular migraine) and chronic pain (fibromyalgia and other diseases) were collected. The biomarkers, imaging features, right-to-left shunt of the heart (lung), genetic characteristics, treatment, and outcome (in relation to other diseases) of headache-related diseases were studied, and long-term follow-up was planned.

NCT ID: NCT04937010 Recruiting - Clinical trials for Trigeminal Autonomic Cephalgia

Occipital Nerve Stimulation in Trigeminal Autonomic Cephalgias

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

The objective of this study is to determine the efficacy of occipital nerve stimulation (ONS) in the treatment of chronic trigeminal autonomic cephalalgias (TACs).

NCT ID: NCT04930887 Recruiting - Migraine Clinical Trials

Clinical Trial of Endoscopically Guided Injection of Exparel (Bupivacaine) for the Treatment of Craniofacial Pain

Start date: February 1, 2023
Phase: Phase 2
Study type: Interventional

Exparel has a proven efficacy in providing pain relief for up to 72 hours with a single-dose administration at surgical sites. The study aims to evaluate the effectiveness of endoscopically-guided injection of Exparel (Bupivacaine) for the treatment of craniofacial pain. This study would be conducted in a prospective, randomized, double-blinded, placebo- controlled, and cross-over fashion. We aim to investigate whether the administration of Exparel (Bupivacaine) to the lateral nasal wall may positively impact craniofacial pain and functional outcomes, in patients who experience relief with the topical application of Lidocaine (routinely given prior to almost all ENT endoscopy).

NCT ID: NCT04906603 Recruiting - Quality of Life Clinical Trials

Theta Burst Stimulation for Headaches After Traumatic Brain Injury

Start date: November 1, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate if theta burst stimulation (TBS) can reduce chronic headaches caused by a traumatic brain injury (TBI). TBS is a safe, drug-free brain stimulation technique that uses magnets to create electricity and stimulate nerve cells in the brain. After repeated TBS sessions, the increased stimulation of nerve cells can alter the way the brain communicates with itself (by creating new neural pathways) which, in turn, can reduce pain symptoms. Participants in this study will complete a baseline assessment followed by four weeks of daily home headache assessment. Participants will then receive four weeks of TBS administered three times per day and three days per week. After TBS is completed, participants will complete an additional four weeks of daily home headache assessment and return for a one-month follow-up assessment. Participation is expected to last three months.

NCT ID: NCT04905953 Recruiting - Headache Clinical Trials

Comparison Of Different Doses Of Intrathecal Neostigmine In Prevention Of Post-Dural Puncture Headache

Start date: February 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

We hypothesized that; intrathecal administration of neostgmine in spinal anesthesia may have a beneficial role in reduction of the incidence or severity of PDPH.

NCT ID: NCT04867967 Recruiting - Clinical trials for Tension-Type Headache

Yoga and MBSR for TTH

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Primary study objectives 1. evaluate the short-term effect of yoga intervention in addition to routine care on headache frequency in patients with frequent or chronic tension-type headache compared to routine care alone (waiting group). 2. to evaluate the short-term effect of yoga intervention in addition to routine care on headache frequency in patients with frequent episodic or chronic tension-type headache compared with stress management through mindfulness-based stress reduction (MBSR) in addition to routine care. Secondary study objectives Evaluation of the medium-term effect of the intervention on headache frequency as well as the short- and medium-term effect on the secondary target parameters in comparison to the waiting group and MBSR. Further evaluation of the safety and acceptability of the intervention.

NCT ID: NCT04857671 Recruiting - Clinical trials for Tension-Type Headache

Botulinum Toxin A in Frequent and Chronic Tension-type Headache

BACT
Start date: October 3, 2022
Phase: Phase 3
Study type: Interventional

Chronic tension-type headache (CTTH) is an underestimated disabling condition that affects a large number of patients. The treatment options for both episodic tension-type headaches, but especially CTTH are few. Poor long-term effects of existing treatment for CTTH (Sarotex, SSRIs, physiotherapy) are reported. Patients with CTTH also have a high risk of developing drug overdose headache (MOH). Non-drug treatments with physiotherapy or alternative medicine also show poor long-term effects. Literature reviews show that there is surprisingly little research on CTTH. Some small clinical trials report a good effect of treatment with botulinum toxin A, but larger controlled trials are needed to confirm or deny this. The investigators will study effect of treatment with botulinum toxin A in CTTH in BACT study, and will include participants with both frequent and chronic TTH with 10 or more headache days per month. If BACT outcomes are positive, this will open a possibility for a new treatment for TTH patients.

NCT ID: NCT04853797 Recruiting - Headache Clinical Trials

Effect of Ivabradine on Levcromakalim-Induced Symptoms in Individuals With Migraine Without Aura (ILIM)

ILIM
Start date: April 16, 2021
Phase: N/A
Study type: Interventional

This study aims to explore the effect of Ivabradine on Levcromakalim-induced migraine in individuals with migraine without aura.

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.