COMPLETED TRIALS
Read more about the completed trials that MedVadis Research is involved with. Contact us anytime if you would like to volunteer for other or have any questions.
Adult Migraine
Study ID 250
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.
Related Conditions: Migraine
Sex/Gender: All
Age: 18+
Enrollment Complete.
Study ID 25X
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.
Related Conditions: Migraine
Sex/Gender: All
Age: 18+
Enrollment Complete.
Study ID 273
Treatment of Head Pain With the SPRINT® Peripheral Nerve Stimulation (PNS) System
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.
Related Conditions: Cervicogenic Headache | Occipital Neuralgia
Sex/Gender: All
Age: 21+
Enrollment Complete.
ALS
Alzheimer's Disease
Study ID 252
The main purpose of this study is to evaluate the safety and efficacy of donanemab in participants with preclinical Alzheimer’s Disease (AD).
The main purpose of this study is to evaluate the safety and efficacy of donanemab in participants with preclinical Alzheimer’s Disease (AD).
Related Conditions: Alzheimer's Disease
Sex/Gender: All
Age: 65-80yrs
Enrollment Complete.
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, 76-week Study Evaluating the Safety and Efficacy of Two Doses of Simufilam in Subjects With Mild-to-Moderate Alzheimer’s Disease
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.
Related Conditions: Alzheimer's Disease
Sex/Gender: All
Age: 50-87yrs
Enrollment Complete.
Study ID 274
Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults With Early Symptomatic Alzheimer’s Disease
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.
Related Conditions: Alzheimer's Disease | Dementia | Brain Diseases | Central Nervous System Diseases
Sex/Gender: All
Age: 60-85yrs
Enrollment Complete.
Study ID 267
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).
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).
Related Conditions: Alzheimer's Disease
Sex/Gender: All
Age: 60-85yrs
Enrollment Complete.
Study ID 282
A Phase 3 Double-blind, Randomized, Placebo-controlled, Multi-center Trial to Evaluate the Efficacy and Safety of AR1001 Over 52 Weeks in Participants With Early Alzheimer’s Disease (Polaris-AD)
This AR1001-ADP3-US01 protocol is a double-blind, randomized, placebo-controlled, multi- center, parallel-group comparison pivotal Phase 3 study to evaluate the efficacy and safety of AR1001 for the treatment of participants with early AD.
Related Conditions: Alzheimer's Disease
Sex/Gender: All
Age: 55-80yrs
Enrollment Complete.
Study ID 277
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.
Related Conditions: Alzheimer's Disease
Sex/Gender: All
Age: 55-85yrs
Enrollment Complete.
Study ID 288
A Seamless Phase 2A-Phase 2B Randomized Double-Blind Placebo- Controlled 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.
Related Conditions: Alzheimer Disease
Sex/Gender: All
Age: 50-89yrs
Enrollment Complete.
Study ID 298
A Study of Remternetug Versus Placebo in Early Alzheimer’s Disease Participants at Risk for Cognitive and Functional Decline
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.
Related Conditions: Alzheimer's Disease
Sex/Gender: All
Age: 55-80yrs
Enrollment Complete.
Study ID 259
Safety and Efficacy of Allopregnanolone (Allo) as a Regenerative Therapeutic for Alzheimer’s Disease: Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Clinical Trial
A phase 2, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of Allopregnanolone as a regenerative therapeutic for Alzheimer’s disease.
Related Conditions: Alzheimer Dimentia | Late Onset Alzheimer's Disease | Neurodegenerative Disease
Sex/Gender: All
Age: 55-80yrs
Enrollment Complete.
Chronic Knee Pain
Chronic Low Back Pain
Diabetic Neuropathy
Study ID 260
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.
Related Conditions: Diabetic Peripheral Neuropathy
Sex/Gender: All
Age: 18-80yrs
Enrollment Complete.
Study ID 268
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.
Related Conditions: Diabetic Neuropathy
Sex/Gender: All
Age: 18-75yrs
Enrollment Complete.
Obesity
Study ID 280
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.
Related Conditions: Obesity | Cardiovascular Disease
Sex/Gender: All
Age: 18+
Enrollment Complete.
Study ID 278
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.
Related Conditions: Obesity | Overweight | Chronic Knee Pain | Knee Osteoarthritis | Obstructive Sleep Apnea
Sex/Gender: All
Age: 18+
Enrollment Complete.
Study ID 279
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.
Related Conditions: Obesity | Overweight | Type 2 Diabetes | Obstructive Sleep Apnea
Sex/Gender: All
Age: 18+
Enrollment Complete.
Study ID 287
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.
Related Conditions: Obesity | Overweight | Osteo Arthritis Knee
Sex/Gender: All
Age: 18+
Enrollment Complete.
Pediatric Migraine
Study ID 224
A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age
The primary objective of the study is to evaluate the effectiveness of fremanezumab as compared to placebo for the preventive treatment of episodic migraine (EM).
Secondary objectives are to further demonstrate the efficacy of Fremanezumab as compared to placebo for the preventive treatment of EM, to evaluate the safety and tolerability of Fremanezumab in the preventive treatment of EM and to evaluate the immunogenicity of Fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in participants exposed to Fremanezumab.
The total duration of the study is planned to be up to 36 months.
Related Conditions: Migraine
Sex/Gender: All
Age: 6-17yrs
Enrollment Complete.
Study ID 225
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.
Related Conditions: Migraine
Sex/Gender: All
Age: 6-17yrs
Enrollment Complete.
Study ID 226
A Study to Test if Fremanezumab is Effective in Preventing Chronic Migraine in Patients 6 to 17 Years of Age
The primary objective of the study is to evaluate the effectiveness of fremanezumab as compared to placebo for the preventive treatment of chronic migraine (CM).
Secondary objectives are to further demonstrate the efficacy of Fremanezumab as compared to placebo for the preventive treatment of CM, to evaluate the safety and tolerability of Fremanezumab in the preventive treatment of CM and to evaluate the immunogenicity of Fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in participants exposed to Fremanezumab
The total duration of the study is planned to be 48 months.
Related Conditions: Migraine
Sex/Gender: All
Age: 6-17yrs
Enrollment Complete.
Study ID 243
A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine (REBUILD-1)
The main purpose of this study is to evaulate the efficacy and safety of galcanezumab in participants 6 to 17 years of age for the preventive treatment of episodic migraine. 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.
Related Conditions: Episodic Migraine
Sex/Gender: All
Age: 6-17yrs
Enrollment Complete.
Study ID 244
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.
Related Conditions: Chronic Migraine
Sex/Gender: All
Age: 12-17yrs
Enrollment Complete.
Study ID 241
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.
Related Conditions: Migraine
Sex/Gender: All
Age: 6-17yrs
Enrollment Complete.
Study ID 242
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.
Related Conditions: Migraine
Sex/Gender: All
Age: 6-17yrs
Enrollment Complete.
Study ID 249
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).
Related Conditions: Acute Treatment of Migraine
Sex/Gender: All
Age: 6-17yrs
Enrollment Complete.