This is a multicenter, double-blind, placebo-controlled study assessing the effectiveness of Galcanezumab as an add-on therapy for Migraine participants on a stable migraine prophylaxis regimen including Botox with or without one other migraine prophylaxis agent (BMPT), who have persistent unmet need. The study population will consist of approximately 150 participants ages 18-65 who report at least a 30% reduction in monthly migraine days from BMPT and still experience an average of ≥ 6 migraine days per month, following International Classification of Headache Disorders (ICHD-3) criteria. Subjects should be stable on at least 2, but no more than 8, consecutive injection cycles of Botox. Overall migraine day reduction will be assessed in the participants based on participant self-report (via daily electronic diaries) and medical record review.

Start Date01 Oct 2022

Sponsor / Collaborator

Diamond Headache Clinic, Ltd.

NCT04465357 / CompletedPhase 4

A Multicenter, Open Label Study Assessing the Efficacy of Erenumab on Functional Impact of Migraine

The purpose of this study is to assess the efficacy of erenumab on functional impact due to Migraine in adults.

Start Date22 Oct 2020

Sponsor / Collaborator

Diamond Headache Clinic, Ltd.

[+1]

NCT00471952 / CompletedPhase 3

Maxalt 10mg Plus Caffeine 75mg in the Acute Treatment of Migraine Headache

The purpose of this study is to evaluate the effect of rizatriptan, alone or combined with caffeine for treating acute attacks of migraine.
Each subject will have 3 months to treat 3 acute migraine headache attacks. Each subject will be dispensed one box containing 3 packets of study medication labeled for Headache #1, Headache #2, or Headache #3. Each packet wil contain either Maxalt 10mg MLT or a Maxalt placebo (sugar pill), and a capsule containing either caffeine 75mg or a capsule containing placebo (sugar).
One headache will be treated with a combination of Maxalt 10mg MLT and caffeine.
Another headache will be treated with a combination of Maxalt 10mg MLT and a capsule containing placebo.
A third headache will be treated with just placebo.
Neither the subject, the study coordinator, or your study doctor will know in which order you will receive the three different treatments. This information is available in case of emergency.

Start Date01 Apr 2007

Sponsor / Collaborator

Diamond Headache Clinic, Ltd.

[+1]

100 Clinical Results associated with Diamond Headache Clinic, Ltd.

0 Patents (Medical) associated with Diamond Headache Clinic, Ltd.

Literatures (Medical) associated with Diamond Headache Clinic, Ltd.

01 Apr 2008·Expert Review of Pharmacoeconomics & Outcomes ResearchQ4 · MEDICINE

Pharmacoeconomic benefits of almotriptan in the acute treatment of migraine

Q4 · MEDICINE

Article

Author: Freitag, Frederick G

Almotriptan is one of seven oral triptans available in the USA and much of the rest of the world. Reviews of its efficacy and tolerability demonstrate it to be among the most effective and well tolerated of this class. Studies of almotriptan in a variety of early intervention paradigms demonstrate significant improvements in efficacy and further improved tolerability compared with standard treatment of headaches of at least moderate severity. The nature of migraine pain and symptoms is such as to produce impairment of the individual in their usual activities, including work, and leads to a significant cost of migraine to the workplace. Utilizing both specific studies examining this and drawing conclusions upon the results of additional trials suggests that, despite the direct costs of this agent, the economic advantages and personal advantages to the patients more than compensate.

01 Mar 2008·Headache: The Journal of Head and Face PainQ2 · MEDICINE

Effect of Early Intervention With Almotriptan vs Placebo on Migraine‐Associated Functional Disability: Results From the AEGIS Trial

Q2 · MEDICINE

Article

Author: Mathew, Ninan ; Mao, Lian ; Smith, Timothy ; Rupnow, Marcia ; Biondi, David ; Finlayson, Gary ; Freitag, Frederick ; Greenberg, Steven ; Wright, Pamela

Objective.— To investigate the effect of early acute migraine intervention with almotriptan vs placebo on functional disability and health‐related quality of life (HRQoL) indicators.Design/Methods.— In this multicenter, double‐blind, parallel‐group trial, adults with international classification of headache disorders‐defined migraine, with or without aura, were randomized 1:1 to treat 3 consecutive headaches with either almotriptan 12.5 mg or placebo. Patients were instructed to take their study medication at the first sign of migraine headache pain of any intensity, within 1 hour of onset. Patients recorded level of functional disability (normal, disturbed, bed rest required, emergency room [ER]/hospitalization required) at baseline (pretreatment), 0.5, 1, 2, 4, and 24 hours posttreatment and at time of pain‐free. Patients completed the Migraine Disability Assessment Scale (MIDAS) at randomization and completed the Migraine Quality‐of‐Life Questionnaire (MQoL) at 24 hours after each attack.Results.— Results are presented for 315 patients (160 almotriptan, 155 placebo) in the evaluable for efficacy population. At 2 hours posttreatment of Attack 1, 54.4%, 32.5%, 13.1%, and 0%, respectively, of almotriptan‐treated patients reported normal function, disturbed function, bed rest required, and ER/hospitalization required compared with 38.1%, 45.2%, 16.1%, and 0.6%, respectively, of placebo‐treated patients. The differences in level of functional disability between the 2 treatment groups were statistically significant at 2 hours (P = .007; Cochran‐Mantel‐Haenszel, stratified by center) and at 4 hours (P < .001). Resolution of pain was associated with a normal level of function; at 2 hours posttreatment, 91.7% of patients in the total population who achieved pain‐free reported normal function compared with 44.8%, 8.0%, and 0% of patients with mild, moderate, and severe pain, respectively. The absence compared with the presence of photophobia, phonophobia, and nausea at 2 hours also was associated with less disability (P < .0001 for each symptom). Treatment with almotriptan compared with placebo resulted in consistently better 24‐hour MQoL scores with significant results for all 3 migraine headache attacks in the social function and feelings/concern domains. A logistic regression model determined that pretreatment functional level (P = .0117), pretreatment pain intensity (P = .0089), and pretreatment MIDAS score (P = .0152) were significant covariates of the proportion of patients who achieved normal function at 2 hours posttreatment.Conclusions.— Early treatment with almotriptan within 1 hour of migraine pain onset significantly reduced levels of functional disability at 2 and 4 hours posttreatment compared with placebo. Consistency in improvement of HRQoL indicators was observed across 3 headaches treated.

01 May 2007·Clinical TherapeuticsQ4 · MEDICINE

The cycle of migraine: Patients' quality of life during and between migraine attacks

Q4 · MEDICINE

Review

Author: Freitag, Frederick G

BACKGROUNDDespite advances in therapy, the prevalence of migraine has remained constant over the past 17 years. The current diagnostic procedure for migraine does not take into account the entire cycle of migraine, which includes both the pain of the acute attack and the worry between attacks.OBJECTIVESThis review discusses the effects of migraine on health-related quality of life. The focus is on the impact of migraine between attacks and more successful clinical management of the complete cycle of migraine in both the neurology and primary care settings.METHODSA search of MEDLINE (January 1997-January 2007) was conducted to determine the impact of migraine on quality of life and the need for and use of migraine preventive treatment. The search terms were migraine prevention, migraine prophylaxis, bead-ache and quality of life, migraine disability, and head-ache disability. The inclusion of specific studies was based on subjective, comparative evaluation and standard levels of evidence. Older publications were included to provide a historical perspective.RESULTSWorry in expectation of the next migraine attack can have negative effects on the family and social lives and work productivity of patients with migraine. The benefits of preventive pharmacotherapy for migraine may be measured over time in terms of changes in the frequency of acute attacks, impact of acute treatment on headache recurrence within the next 24 hours, and reduction in overall functional impairment. Optimizing the acute treatment outcome and reducing the frequency of episodes may help alleviate the cycle of migraine. The clinical assessment of migraine should include multiple dimensions. Several questionnaires, such as the Migraine Disability Assessment and the 6-item Headache Impact Test, have been developed to help clinicians assess the dimensions of migraine. These questionnaires should be used in conjunction with open communication techniques that elicit any underlying worry associated with migraines. Preventive therapies that have been approved by the US Food and Drug Administration include the neurostabilizers divalproex sodium and topiramate, and the beta-blockers timolol and propranolol. Despite not being approved for this indication, the antidepressant amitriptyline has shown levels of evidence of efficacy in preventing migraine in controlled trials similar to those for the approved medications.CONCLUSIONThe assessment of whether patients with migraine may benefit from preventive therapy should include the use of open communication techniques to uncover possible impairment between attacks.

100 Deals associated with Diamond Headache Clinic, Ltd.

100 Translational Medicine associated with Diamond Headache Clinic, Ltd.

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