A Trial of the Efficacy and Safety of CVL-865 as Adjunctive Therapy in the Treatment of Focal Onset Seizures

March 6, 2024 updated by: Cerevel Therapeutics, LLC

A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Trial of CVL-865 as Adjunctive Therapy in Adults With Drug-Resistant Focal Onset Seizures (REALIZE Trial)

The purpose of this study is to assess the efficacy, safety, and tolerability profile of CVL-865 as adjunctive treatment in participants with drug-resistant focal onset seizures.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Completed
        • Camperdown, New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Completed
        • Randwick, New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Completed
        • Westmead, New South Wales
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Completed
        • Herston, Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Completed
        • South Brisbane, Queensland
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Withdrawn
        • Bedford Park, SA
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Withdrawn
        • Box Hill, Victoria
      • Fitzroy, Victoria, Australia, 3065
        • Completed
        • Fitzroy, Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Completed
        • Heidelberg, Victoria
      • Melbourne, Victoria, Australia, 3004
        • Completed
        • Melbourne, Victoria
      • Parkville, Victoria, Australia, 3050
        • Completed
        • Parkville, Victoria
  • Poland
      • Białystok, Poland, 15-704
        • Recruiting
        • Białystok
        • Contact:
      • Lublin, Poland, 20-078
        • Completed
        • Lublin
      • Warszawa, Poland, 02-952
    • Kujawsko-Pomorskie
      • Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-163
        • Completed
        • Bydgoszcz, Kujawsko-Pomorskie
    • Lodz
      • Łódź, Lodz, Poland, 90-752
    • Malopolskie
      • Kraków, Malopolskie, Poland, 31-209
        • Completed
        • Kraków, Malopolskie
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-119
        • Completed
        • Warszawa, Mazowieckie
    • Pomorskie
      • Gdańsk, Pomorskie, Poland, 80-546
        • Completed
        • Gdańsk, Pomorskie
      • Gdańsk, Pomorskie, Poland, 80-803
        • Completed
        • Gdańsk, Pomorskie
    • Wojnicz Lskie
      • Wojnicz, Wojnicz Lskie, Poland, 40-650
        • Recruiting
        • Wojnicz, Lskie
        • Contact:
  • Serbia
      • Belgrade, Serbia, 11000
        • Completed
        • Belgrade
      • Belgrade, Serbia, 11000
        • Completed
        • Clinic of Neurology, Belgrade
      • Niš, Serbia, 18000
        • Recruiting
        • Niš
        • Contact:
    • Sumadija
      • Kragujevac, Sumadija, Serbia, 34000
      • Kragujevac, Sumadija, Serbia, 34000
        • Recruiting
        • Neurology Department, Kragujevac
        • Contact:
  • Spain
      • Barcelona, Spain, 8035
        • Completed
        • Barcelona
      • Madrid, Spain, 28027
        • Completed
        • Madrid
      • Madrid, Spain, 28034
        • Completed
        • Madrid
      • Madrid, Spain, 28040
        • Completed
        • Madrid
      • Sevilla, Spain, 41013
        • Completed
        • Sevilla
      • Valencia, Spain, 46026
        • Completed
        • Valencia
    • Andalusia
      • Málaga, Andalusia, Spain, 29010
        • Completed
        • Malaga,
    • Catalonia
      • Barcelona, Catalonia, Spain, 08003
        • Recruiting
        • Barcelona, Catalunya
        • Contact:
      • Terrassa, Catalonia, Spain, 08222
        • Completed
        • Terrassa
    • Navarra
      • Navarro, Navarra, Spain, 31008
        • Recruiting
        • Navarra
        • Contact:
  • Ukraine
      • Kyiv, Ukraine, 02091
        • Recruiting
        • Kyiv
        • Contact:
      • Lviv, Ukraine, 79035
    • Uzhgorod
      • Úzhgorod, Uzhgorod, Ukraine, 88018
        • Recruiting
        • Uzhgorod
        • Contact:
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • Downey, California, United States, 90242
        • Completed
        • Downey, California
      • Loma Linda, California, United States, 92354
        • Completed
        • Loma Linda, California
      • Los Angeles, California, United States, 90048
        • Withdrawn
        • Los Angeles, California
      • Valencia, California, United States, 91355
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Withdrawn
        • Colorado Springs, Colorado
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Completed
        • New Haven, Connecticut
    • Florida
      • Altamonte Springs, Florida, United States, 32714
        • Completed
        • Altamonte Springs, Florida
      • Gulf Breeze, Florida, United States, 32561-4458
        • Completed
        • Gulf Breeze, Florida
      • Homestead, Florida, United States, 33032
        • Completed
        • Homestead, Florida
      • Jacksonville, Florida, United States, 32224
        • Completed
        • Jacksonville, Florida
      • Miami, Florida, United States, 33156
        • Withdrawn
        • Miami, Florida
      • Miami, Florida, United States, 33136
        • Completed
        • Miami, Florida
      • Miami Lakes, Florida, United States, 33016
      • Orlando, Florida, United States, 32806
        • Completed
        • Orlando, Florida
      • Port Charlotte, Florida, United States, 33952
        • Completed
        • Port Charlotte, Florida
      • Port Orange, Florida, United States, 32127
        • Completed
        • Port Orange, Florida
      • Tallahassee, Florida, United States, 32308
        • Withdrawn
        • Tallahassee, Florida
      • Tampa, Florida, United States, 33606
        • Completed
        • Tampa, Florida
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Withdrawn
        • Atlanta, Georgia
      • Suwanee, Georgia, United States, 30024
        • Completed
        • Suwanee, Georgia,
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Completed
        • Honolulu, Hawaii
    • Idaho
      • Boise, Idaho, United States, 83702
        • Withdrawn
        • Boise, Idaho
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Withdrawn
        • Urbana, Illinois
      • Winfield, Illinois, United States, 60190
        • Withdrawn
        • Winfield, Illinois
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Completed
        • Lexington, Kentucky
    • Maine
      • Scarborough, Maine, United States, 04074
        • Completed
        • Scarborough, Maine
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Completed
        • Baltimore, Maryland
      • Bethesda, Maryland, United States, 20817
        • Completed
        • Bethesda, Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Completed
        • Boston, Massachusetts
    • Minnesota
      • Roseville, Minnesota, United States, 55113
        • Withdrawn
        • Roseville, Minnesota
    • Missouri
      • Chesterfield, Missouri, United States, 63005
      • Saint Louis, Missouri, United States, 63110
        • Completed
        • Saint Louis, Missouri
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Completed
        • Hackensack, New Jersey
    • New York
      • Bronx, New York, United States, 10467
        • Withdrawn
        • Bronx, New York
      • Mineola, New York, United States, 11501
        • Completed
        • Mineola, New York
      • New York, New York, United States, 10016
        • Withdrawn
        • New York
      • New York, New York, United States, 10021
        • Completed
        • New York
      • Rochester, New York, United States, 14642
        • Completed
        • Rochester, New York
      • Syracuse, New York, United States, 13210
        • Completed
        • Syracuse, New York
    • Ohio
      • Columbus, Ohio, United States, 43221
        • Completed
        • Columbus, Ohio
      • Toledo, Ohio, United States, 43614
        • Completed
        • Toledo, Ohio
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Completed
        • Oklahoma City, Oklahoma
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Completed
        • Philadelphia, Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Completed
        • Philadelphia, Pennsylvania
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Completed
        • Charleston, South Carolina
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Withdrawn
        • Cordova, Tennessee
      • Nashville, Tennessee, United States, 37232
        • Completed
        • Nashville, Tennessee
    • Texas
      • Dallas, Texas, United States, 75390
        • Withdrawn
        • Dallas, Texas
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Completed
        • Salt Lake City, Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants with a diagnosis of epilepsy with focal onset, as defined in the International League Against Epilepsy (ILAE) Classification of Seizures, focal aware (except participants with only focal aware seizures without a motor component), focal impaired awareness, and focal to bilateral tonic-clonic seizures for at least 2 years prior to signing the Informed Consent Form (ICF)
  • Participants must have history of an average of 4 or more spontaneous and observable focal onset, as defined in the ILAE Classification of Seizures, focal aware (except participants with only focal aware seizures without a motor component), focal impaired awareness, and focal to bilateral tonic-clonic seizures per 28-day period for at least 3 months (84 days) prior to signing the ICF
  • Participants who have tried and failed at least 2 appropriate Anti- epileptic drugs (AEDs) in the past and also currently taking 1 to 3 permitted AEDs at a stable dose for 4 Weeks prior to the Screening Visit
  • Participants with a minimum of 8 focal onset, focal aware, focal impaired awareness, or focal to bilateral tonic-clonic seizures during the 8 week baseline period with no 21-day period free of any of these seizure types
  • Participants must have had magnetic resonance imaging or contrast enhance computed tomography scan of the brain that demonstrated no progressive structural central nervous system abnormality at the time of the diagnosis of epilepsy
  • Participants must have a body mass index (BMI) of 17.5 to 40.0 kilogram per meter square (kg/m^2) and a total body weight greater than (>) 50 kilograms (kg) [110 pounds (lbs)]
  • Women of childbearing potential must agree to use an effective method of contraception from signing of informed consent throughout the duration of the study and for 30 days post last dose
  • Male must agree to use condom during treatment and until the end of relevant systemic exposure in the male participant for 94 days following the last dose with Investigational Manufacturing Product (IMP)

Exclusion Criteria:

  • Participants with (genetic) idiopathic generalized epilepsies or combined generalized and focal epilepsies, including a history of Lennox-Gastaut Syndrome
  • Participants with a history of seizures over the past 12 months that occur at such a high frequency they cannot be counted (eg, repetitive seizures, cluster seizures)
  • Participants with a history of psychogenic non-epileptic seizures within the year prior to signing the ICF
  • Participants with a history of status epilepticus within 5 years prior to signing the ICF
  • Participants with a history of neurosurgery for seizures less than 1 year prior to signing the ICF, or radiosurgery less than 2 years prior to signing the ICF
  • Participants with a current history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, hematological, immunological, or neurological (excluding focal onset epilepsy) disease
  • Participants who test positive for human immunodeficiency virus (HIV), hepatitis B and/or or hepatitis C infection
  • Participants with a 12-lead ECG demonstrating : QT interval corrected for heart rate using Fridericia's formula >450 milliseconds (msec) (average of 3 ECGs obtained at the Screening Visit); QRS interval >120 msec at the Screening Visit assessed by central reader
  • Participants with abnormal laboratory test results which includes (Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) elevated to >2 × Upper limit of normal range (ULN); Total bilirubin greater than or equal to (>=)1.5 × ULN; Females: Hemoglobin <11 gram per deciliter (g/dL); Males: hemoglobin <12 g/dL; White blood cell (WBC) count <3.0 x 10 power 9 per liter (10^9/L); Neutrophil count <2.0 x 10^9/L; Platelet count <150 × 10^9/L
  • Use of prohibited medications as listed in the protocol in the absence of appropriate washout phase or the likelihood of requiring treatment during the study period with drugs not permitted by the study protocol
  • Participants taking any drug that is a sensitive P-glycoprotein (P-gp) and Breast cancer resistance protein (BCRP) substrate
  • Female participants who are breastfeeding and/or who have a positive pregnancy test result prior to receiving IMP
  • Participants who are known to be allergic or hypersensitive to the IMP or any of its components
  • Participants who have participated in any clinical trial within 60 days prior to signing the ICF or who have participated in more than 2 clinical trials within the year prior to signing the ICF
  • Participants with difficulty swallowing
  • Participants who answer "Yes" on the C-SSRS Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) and whose most recent episode meeting criteria for this C-SSRS Item 4 occurred within the last 6 months, OR Subjects who answer "Yes" on the C-SSRS Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting criteria for this CSSRS Item 5 occurred within the last 6 months OR Subjects who answer "Yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose most recent episode meeting criteria for any of these 5 C-SSRS Suicidal Behavior Items occurred in the last 2 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Dose: CVL-865 25 mg
Participants will receive CVL-865 tablets orally twice daily (BID) up to the maximum dose of 25 milligrams (mg) until Day 92 during the treatment period.
Drug: CVL-865
Participants will receive CVL-865 tablets orally BID up to the maximum dose of 7.5 mg BID or 25 mg BID during the treatment period.
Experimental: Low Dose: CVL-865 7.5 mg
Participants will receive CVL-865 tablets orally BID up to the maximum dose of 7.5 mg until Day 92 during the treatment period.
Drug: CVL-865
Participants will receive CVL-865 tablets orally BID up to the maximum dose of 7.5 mg BID or 25 mg BID during the treatment period.
Placebo Comparator: Placebo
Participants will receive a placebo matched to CVL-865 tablets orally BID until Day 92 during the treatment period.
Drug: Placebo
Participants will receive CVL-865 matched placebo tablet orally BID during the treatment period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Ratio (RRatio)
Time Frame: Day 71
Response Ratio (RRatio), calculated as RRatio=(T-B)/(T+B) ×100, where T represents the focal onset seizure frequency rate per week in the Maintenance Phase and B represents the focal onset seizure frequency rate per week in the Baseline Period.
Day 71

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Focal Onset Seizure Frequency per Week over the Maintenance Phase
Time Frame: Baseline up to Day 71
Seizure frequency is defined as the total number of focal onset seizures over the treatment period of interest divided by the total number of days with no missing seizure counts in the corresponding period multiplied by 7.
Baseline up to Day 71
Percentage of Participants with 50 Percent (%) Responder Rate
Time Frame: Day 71
Defined as the percent of participants with at least a 50% reduction in the Maintenance Phase focal onset seizure frequency rate relative to the Baseline Period.
Day 71
Percentage of Seizure-free Participants
Time Frame: Baseline up to Day 71
Seizure freedom is defined as the absence of all seizure regardless of seizure type.
Baseline up to Day 71
Seizure Rate over Time
Time Frame: Baseline up to Day 71
Seizure frequency is defined as the total number of focal onset seizures over the treatment period of interest divided by the total number of days with no missing seizure counts in the corresponding period multiplied by 7.
Baseline up to Day 71
Patient's Global Impression of Change (PGIC) Score at Days 15, 43 and 71
Time Frame: Baseline, Day 15, 43 and 71
The self-report measure Patient's Global Impression of Change (PGIC) reflects a participant's belief about the efficacy of treatment. It is a 7-point scale depicting a participant's rating of overall improvement where 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse and 7 = very much worse.
Baseline, Day 15, 43 and 71
Change from Baseline in Clinical Global Impression-Severity of Symptoms Scale (CGI-S) Score at Day 15, 43 and 71
Time Frame: Baseline, Day 15, 43 and 71
The CGI-S is an observer-rated scale that will be used to measure symptom severity. It is a 7-point scale depicting a participants rating of overall improvement. Participants rate their change as 0 = not assessed; 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.
Baseline, Day 15, 43 and 71
Change From Baseline in Clinical Global Impression-Improvement Scale (CGI-I) Score at Day 15, 43 and 71
Time Frame: Baseline, Day 15, 43 and 71
The CGI-I is an observer-rated scale that will be used to measure the participant's symptom severity compared with before initiation of treatment with IMP. It is a 7-point scale depicting a participant's change from baseline in symptom severity using the following response choices: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.
Baseline, Day 15, 43 and 71
Change from Baseline in Quality of Life in Epilepsy -31 (QOLIE-31) Overall Score at Day 71
Time Frame: Baseline, Day 71
The Quality of Life in Epilepsy - 31 (QOLIE-31) contains 7 multi-item scales that tap the following health concepts: emotional well-being, social functioning, energy/fatigue, cognitive functioning, seizure worry, medication effects, and overall quality of life. A QOLIE-31 overall score is obtained using a weighted average of the multi-item scale scores. The QOLIE-31 also includes a single item that assessed overall health. The QoLIE-31 score range is from 0 to 100 with a higher score indicating a better outcome for quality of life.
Baseline, Day 71
Change from Baseline in Health Utilities Index (HUI) Utility Score at Day 71
Time Frame: Baseline, Day 71
The Health Utilities Index (HUI) is a rating scale used to measure general health status and health-related quality of life. In HUI, utility values range from -0.03 and -0.36 for the HUI-2 and HUI-3, respectively, to 1.00. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death.
Baseline, Day 71
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECGs)
Time Frame: Baseline to Day 92 or early termination
12-lead ECGs recordings will be obtained after the participant has been supine and at rest for at least 5 minutes.
Baseline to Day 92 or early termination
Number of Participants with Clinically Significant Changes in Vital Sign Measurements
Time Frame: Baseline to Day 92 or early termination (ET)
Vital signs will be measured with the participant in a sitting/semi-recumbent position after 5 minutes rest and will include temperature, systolic and diastolic blood pressure, and heart rate.
Baseline to Day 92 or early termination (ET)
Number of Participants with Clinically Significant Changes in Physical and Neurological Examination Results
Time Frame: Baseline to Day 92 or early termination (ET)
Number of participants with clinically significant changes in physical and neurological examination results will be assessed.
Baseline to Day 92 or early termination (ET)
Number of Participants With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS)
Time Frame: From first dose of study drug up to Day 120 (follow up period)
The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).
From first dose of study drug up to Day 120 (follow up period)
Number of Participants with Positive Response to Modified Clinical Institute Withdrawal Assessment - Benzodiazepines (mCIWA-B)
Time Frame: Day 71 up to Day 120
The modified Clinical Institute Withdrawal Assessment - Benzodiazepines (mCIWA-B) is a sensitive instrument to measure withdrawal under conditions where there is a taper of medication (rather than abrupt discontinuation). It consists of 17-items that monitor the type and severity of BZD withdrawal symptoms such as irritability, fatigue, appetite, and sleeplessness. The total score ranges from 1 to 68 with higher scores indicating more severe withdrawal.
Day 71 up to Day 120
Number of Participants With Treatment Emergent Adverse Event (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time Frame: From first dose of study drug up to Day 120 (follow up period)
TEAEs will include abuse-related AEs and AEs related to medication handling irregularities (MHIs). Number of Participants With TEAEs and TESAEs will be assessed.
From first dose of study drug up to Day 120 (follow up period)
Plasma Concentrations of CVL-865
Time Frame: Day 15, Day 43, Day 71, Day 92 and/or early termination (ET)
Plasma concentration of CVL-865 at Day 15, Day 43, Day 71, Day 92 and/or early termination (ET) will be assessed.
Day 15, Day 43, Day 71, Day 92 and/or early termination (ET)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cerevel Therapeutics, LLC

Investigators

  • Study Director: Eliza Hueda, MD, Cerevel Therapeutics, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2020

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

January 24, 2020

First Submitted That Met QC Criteria

January 24, 2020

First Posted (Actual)

January 28, 2020

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVL-865-SZ-001
  • 2019-002576-14 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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