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Clinical Studies

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  • A Phase 2, Multicenter, Randomized, Proof-of-Concept, Double Blind, Placebo Controlled, Parallel Group Study Comparing the Efficacy and Safety of 1 Subcutaneous Dose Regimen of Fremanezumab Versus Placebo for the Prevention of Persistent Posttraumatic Headache (PPTH) Scottsdale/Phoenix, Ariz.

    A study to test if Fremanezumab reduces headache in patients with Posttraumatic Headache (PTH)

  • Evaluation of Peripheral Nerve Stimulation for Acute Treatment of Migraine Pain Scottsdale/Phoenix, Ariz. The study sponsor has developed a non-invasive treatment for reducing migraine pain. The Theranova Migraine Treatment System uses electrical stimulation applied to the skin.
  • Metformin for the Prevention of Episodic Migraine: a Randomized, Double-blind, Placebo-controlled, Crossover Study (MPEM) Scottsdale/Phoenix, Ariz.

    Migraine is the third most prevalent disease in the world. Preventive treatment is indicated in about 40% of individuals with episodic migraine. Although 4 treatments are approved by the US Food and Drug Administration for prevention of episodic migraine, none were designed to prevent migraine, efficacy is modest, and all have significant adverse-event profiles. As a result, less than 1/3 of migraine sufferers with who are candidates for prevention receive drug treatment and of those who are treated, more than 85% have discontinued the preventive drug within one year. Migraine pain is associated with the activation and sensitization of specific receptors involved in pain-promoting pathways. Metformin, which is a widely available, well-tolerated anti-diabetic medication, can downregulate pain-promoting pathways. Metformin has demonstrated positive results in animal models of migraine in the laboratory. Given the longstanding use and established safety record of metformin, the investigators will evaluate the safety and efficacy of metformin for preventive treatment of high-frequency episodic migraine in a randomized, double-blind, placebo-controlled, crossover trial.

  • Prolactin in Women with Chronic Migraine Scottsdale/Phoenix, Ariz.

    The purpose of this study is to identify whether there is a difference in prolactin levels between patients with chronic migraine and healthy controls. This may help to explain the sensitivity to pain those patients with chronic migraine experience and may also help to establish a target for new treatments of chronic migraine

  • Understanding Post-Traumatic Headache: Forward Translation of a Posttraumatic Headache Animal Model to Posttraumatic Headache in the Human Scottsdale/Phoenix, Ariz.

    Headache is the most commonly reported symptom after trauma to the head. Although posttraumatic headache (PTH) shares some clinical characteristics with primary headache disorders, such as migraine, there are many unique features including head trauma and the exacerbation of headache with physical and cognitive stressors. The purpose of this study is to determine if subjects who have recently sustained a mild TBI and have PTH will have lower pain thresholds (i.e. hyperalgesia) and greater allodynia compared to healthy controls. The study will also determine if exposure to a bright light stressor will exacerbate hyperalgesia in subjects with mild TBI and PTH while healthy controls will not be affected.