Study ID 291

Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine

A migraine is a moderate to severe headache typically on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. Menstrual migraine (MM) is defined as migraine attacks that occur within the perimenstrual period (PMP) in at least 2 out of 3 menstrual cycles. The PMP is from 2 days before the onset of menstrual bleeding to 2 days after. This study will assess how safe and effective ubrogepant is in treating menstrual migraine. Adverse Events and change in disease activity will be assessed.

Ubrogepant is an investigational drug being developed for short-term prevention of menstrual migraine. Participants will be randomly assigned to one of the 2 groups to receive either ubrogepant or placebo. Around 450 adult female participants with menstrual migraine will be enrolled in approximately 85 sites in the United States and Puerto Rico.

Participants will receive oral ubrogepant tablets once daily for 7 consecutive days starting 3 days prior to estimated onset of menses per cycle for 3 PMPs during double-blind period (16 weeks). Eligible participants may continue to receive oral ubrogepant tablets once daily for 7 consecutive days per cycle starting 3 days prior to estimated onset of menses during open-label extension period (52 weeks).

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will collect data daily in electronic diaries and attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

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related conditions:
Adult Migraine
sex/gender:
Female
age:
18yrs and older
enrolling now!

SPRINT® Peripheral Nerve Stimulation for the Treatment of Head Pain

The purpose of this study is to learn if pain can be relieved by delivering small amounts of electricity (called “electrical stimulation”) to the nerves at the top of the neck. This study will use a device called the SPRINT® PNS System. PNS stands for peripheral nerve stimulation (PNS). This device is cleared by the FDA for up to 60 days of use for relief of chronic or acute pain.

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related conditions:
Cervicogenic Headache | Occipital Neuralgia
sex/gender:
All
age:
21+
enrollment complete.

Extension Study of ABP-20001 to Evaluate Safety and Efficacy of Repeat Treatments of ABP-450 for Migraine Prevention

This Phase 2 Extension trial will evaluate the efficacy and safety of ABP-450 for migraine prevention in adults who suffer from six or more migraine days per month. The study will enroll approximately 666 patients across approximately 65 sites in the United States, Canada and Australia from the Phase 2 trial. Study subjects will be divided evenly across a low dose group and a high dose group. All patients will receive four treatment cycles of ABP-450 utilizing the Company’s novel injection paradigm.

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related conditions:
Migraine
sex/gender:
All
age:
18+
enrollment complete.

Investigation of Safety and Efficacy of ABP-450 for Migraine Prevention in Adults

This Phase 2 trial will evaluate the efficacy and safety of ABP-450 for migraine prevention in adults who suffer from six or more migraine days per month. The study will enroll 765 patients across approximately 64 sites in the United States, Canada and Australia. Study subjects will be divided evenly across a low dose group, a high dose group and a placebo group. All patients will receive two treatment cycles of ABP-450 or placebo utilizing the Company’s novel injection paradigm.

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related conditions:
Migraine
sex/gender:
All
age:
18+
enrollment complete.

A Single-Site Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives

To collect, preserve, and/or distribute annotated biospecimens and associated medical data to institutionally approved, investigator-directed biomedical research to discover and develop new treatments, diagnostics, and preventative methods for specific and complex conditions.

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related conditions:
Age-Related Macular Degeneration | Allergies | Alpha-Gal Syndrome | Alzheimer Disease
sex/gender:
All
age:
18-85yrs
enrolling now!

A Study of Remternetug (LY3372993) in Early Alzheimer’s Disease (TRAILRUNNER-ALZ 3)

The purpose of this study is to measure the difference in time to developing or worsening memory, thinking, or functional problems due to Alzheimer’s disease occurring in participants receiving study drug compared to placebo.

Participation could last up to 255 weeks including screening, a double-blind treatment period, and a double-blind observation period. In addition, eligible participants who receive placebo during the double-blind treatment period may choose to extend their study participation to receive open-label remternetug in an extension period.

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related conditions:
Alzheimer’s Disease
sex/gender:
All
age:
55-80yrs
enrollment complete.

A Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer’s Disease (BenfoTeam)

The purpose of this study is to learn more about the safety, effectiveness and tolerability of the study drug called Benfotiamine which may delay or slow the progression of the symptoms of early Alzheimer’s disease.

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related conditions:
Alzheimer Disease
sex/gender:
All
age:
50-89yrs
enrollment complete.

A Dose-ranging Study to Investigate Efficacy of Buntanetap in Mild to Moderate AD

The purpose of this study is to measure efficacy and safety of three different doses of buntanetap compared with placebo in participants with mild to moderate Alzheimer’s disease.

Study details include:

The double-blind treatment duration will include a screening period of up to 42 days followed by 12 weeks of treatment at home.

The study duration will be 4-5 months. There will be 4 in-clinic visits and 1 phone call.

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related conditions:
Alzheimer’s Disease
sex/gender:
All
age:
55-85yrs
enrollment complete.

A Study of Remternetug (LY3372993) in Participants With Alzheimer’s Disease (TRAILRUNNER-ALZ 1)

The reason for this study is to collect safety and efficacy information regarding the study drug remternetug in participants with early Alzheimer’s disease (AD).

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related conditions:
Alzheimer’s Disease
sex/gender:
All
age:
60-85yrs
enrollment complete.

A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer’s Disease (TRAILBLAZER-ALZ 6)

This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer’s disease (AD) and explore participant characteristics that might predict risk of ARIA.

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related conditions:
Alzheimer’s Disease | Dementia | Brain Diseases | Central Nervous System Diseases
sex/gender:
All
age:
60-85yrs
enrollment complete.

A Donanemab (LY3002813) Prevention Study in Participants With Alzheimer’s Disease (TRAILBLAZER-ALZ 3)

The main purpose of this study is to evaluate the safety and efficacy of donanemab in participants with preclinical Alzheimer’s Disease (AD).

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related conditions:
Alzheimer’s Disease
sex/gender:
All
age:
65-80yrs
enrollment complete.

Simufilam 50 mg or 100 mg for Mild-to-Moderate Alzheimer’s Disease (REFOCUS-ALZ)

A 76-week safety and efficacy study of simufilam (PTI-125) given twice daily to participants with mild-to-moderate Alzheimer’s disease (AD) for 76 weeks. Approximately 1083 participants will be randomized (1:1:1) to receive either placebo, 50 mg tablets of simufilam, or 100 mg tablets of simufilam, twice daily, for 76 weeks. Clinic visits will occur 4 weeks after the baseline visit, and then every 12 weeks until the end of the study. The safety of simufilam, and its efficacy in enhancing cognition and slowing cognitive and functional decline will be evaluated.

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related conditions:
Alzheimer’s Disease
sex/gender:
All
age:
50-87yrs
enrollment complete.

Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine (SUZ) in participants with pain associated with diabetic peripheral neuropathy (DPN).

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related conditions:
Diabetic Neuropathy
sex/gender:
All
age:
18-80yrs
enrolling now!

A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain (NEPTUNE-17)

This is a multicenter randomized, double-blind, placebo-controlled phase 2 study to evaluate efficacy, safety, tolerability, pharmacokinetics, and target engagement of GSK3858279 in adult participants with chronic Diabetic Peripheral Neuropathic Pain (DPNP). The primary objective of the study is to assess the efficacy of GSK3858279 in participants with DPNP who have been unable to sufficiently manage their pain.

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related conditions:
Diabetic Neuropathy
sex/gender:
All
age:
18-75yrs
enrollment complete.

Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN)

The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating Painful DPN.

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related conditions:
Diabetic Peripheral Neuropathy
sex/gender:
All
age:
18-80yrs
enrollment complete.

Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Retatrutide once weekly in participants who have obesity or overweight and chronic low back pain (TRIUMPH-7)

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related conditions:
sex/gender:
age:
coming soon…

A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee (TRIUMPH-4)

The main purpose of this study is to evaluate the safety and efficacy of retatrutide once-weekly in participants who have obesity or are overweight and have osteoarthritis (OA) of the knee. The study will lasts about 77 weeks.

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related conditions:
Obesity | Overweight | Osteo Arthritis Knee
sex/gender:
All
age:
18+
enrollment complete.

A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight (TRIUMPH-2)

The purpose of this study is to is to evaluate the efficacy and safety of retatrutide in participants with type 2 diabetes in participants who have obesity or overweight (J1I-MC-GZBK master protocol) including a subset of participants who have obstructive sleep apnea (OSA) (J1I-MC-GSA2). The study will last about 89 weeks and will include up to 24 visits.

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related conditions:
Obesity | Overweight | Type 2 Diabetes | Obstructive Sleep Apnea
sex/gender:
All
age:
18+
enrollment complete.

A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight (TRIUMPH-1)

The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1). This study will last about 89 weeks and will include up to 24 visits.

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related conditions:
Obesity | Overweight | Chronic Knee Pain | Knee Osteoarthritis | Obstructive Sleep Apnea
sex/gender:
All
age:
18+
enrollment complete.

A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease

The main purpose of this study is to evaluate the efficacy and safety of retatrutide once weekly in participants with obesity and established cardiovascular disease (CVD). The study will last about 113 weeks.

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related conditions:
Obesity | Cardiovascular Disease
sex/gender:
All
age:
18+
enrollment complete.

Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine

The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of moderate or severe migraine in children and adolescents (≥ 6 to < 18 years of age).

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related conditions:
Acute Treatment of Migraine
sex/gender:
All
age:
6-17yrs
enrollment complete.

A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine (PIONEER-PEDS2)

The reason for this 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17. The study will last about 12 months and may include up to 7 visits.

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related conditions:
Migraine
sex/gender:
All
age:
6-17yrs

A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine (PIONEER-PEDS1)

The reason for this study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine. The study will last up to 20 weeks and may include up to 4 visits.

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related conditions:
Migraine
sex/gender:
All
age:
6-17yrs
enrollment complete.

A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine (REBUILD-2)

The main purpose of this study is to evaluate the efficacy and safety of galcanezumab for the preventive treatment of chronic migraine in participants 12 to 17 years of age. The primary objective is to demonstrate the superiority of galcanezumab versus placebo in the reduction of monthly migraine headache days across the 3-month double-blind treatment period.

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related conditions:
Chronic Migraine
sex/gender:
All
age:
12-17yrs
enrollment complete.

A Study to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents

The primary objective of the study is to evaluate the long-term safety and tolerability of subcutaneous fremanezumab in the preventive treatment of migraine in pediatric participants 6 to 17 years of age (inclusive at enrollment in the pivotal study).

Secondary objectives are to evaluate the efficacy of subcutaneous fremanezumab in pediatric participants with migraine and to evaluate the immunogenicity of fremanezumab and the impact of ADAs on clinical outcomes in pediatric participants exposed to fremanezumab.

The total duration of the study is planned to be up to 60 months.

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related conditions:
Migraine
sex/gender:
All
age:
6-17yrs
enrollment complete.