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A Randomized Study of BPN14770 in Male Adolescents (Aged 12 to < 18 Years) With Fragile X Syndrome

Primary Purpose

Fragile X Syndrome

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
zatolmilast
Placebo
Sponsored by
Tetra Discovery Partners
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fragile X Syndrome

Eligibility Criteria

12 Years - 18 Years (Child, Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Patient is male adolescent aged 12 to < 18 years. 2. Patient has FXS with a molecular genetic confirmation of the full fragile X mental retardation-1 (FMR1) mutation (≥ 200 CGG repetitions).

    3. Current treatment with ≤ 3 prescribed psychotropic medications. Anti-epileptic medications are permitted and are not counted as psychotropic medications if they are used for treatment of seizures. Anti-epileptics for other indications, such as the treatment of mood disorders, count towards the limit of permitted medications.

    4. Permitted concomitant psychotropic medications must be at a stable dose and dosing regimen for at least 4 weeks before screening and must remain stable during the period between screening and the commencement of study drug.

    5. Anti-epileptic medications must be at a stable dose and dosing regimen for 12 weeks before screening and must remain stable during the period between screening and the commencement of study drug.

    6. Patients with a history of seizure disorder who are currently receiving treatment with anti-epileptics must have been seizure-free for 3 months before screening or must be seizure-free for 2 years if not currently receiving anti-epileptics.

    7. Behavioral and other non-pharmacological treatments/interventions must be stable for 4 weeks before screening and must remain stable during the period between screening and the commencement of study drug, and throughout the study. Minor changes in hours or times of therapy that are not considered clinically significant will not be exclusionary. Changes in therapies provided through a school program, due to school vacations, are allowed.

    8. Patient must be willing to practice barrier methods of contraception while on study, if sexually active. Abstinence is also considered a reasonable form of birth control in this study population.

    9. Patient has a parent(s), legal authorized guardian(s), or consistent caregiver(s).

    10. Patient and caregiver are able to attend the clinic regularly and reliably. 11. Patient's parent(s), legal authorized guardian(s), or consistent caregiver(s) is able to understand and sign an informed consent form to participate in the study.

    12. Patient must provide assent for participation in the study if the patient has the cognitive ability to provide assent.

Exclusion Criteria:

Diagnosis and main criteria for inclusion:

The eligibility criteria are the same for all parts of the study except for Part 1 (PK), where patients must be able to swallow capsules and must weigh at least 75 lbs (34 kg) to receive the 50 mg dose.

Patient Inclusion Criteria

  1. Patient is male adolescent aged 12 to < 18 years.
  2. Patient has FXS with a molecular genetic confirmation of the full fragile X mental retardation-1 (FMR1) mutation (≥ 200 CGG repetitions).
  3. Current treatment with ≤ 3 prescribed psychotropic medications. Anti-epileptic medications are permitted and are not counted as psychotropic medications if they are used for treatment of seizures. Anti-epileptics for other indications, such as the treatment of mood disorders, count towards the limit of permitted medications.
  4. Permitted concomitant psychotropic medications must be at a stable dose and dosing regimen for at least 4 weeks before screening and must remain stable during the period between screening and the commencement of study drug.
  5. Anti-epileptic medications must be at a stable dose and dosing regimen for 12 weeks before screening and must remain stable during the period between screening and the commencement of study drug.
  6. Patients with a history of seizure disorder who are currently receiving treatment with anti-epileptics must have been seizure-free for 3 months before screening or must be seizure-free for 2 years if not currently receiving anti-epileptics.
  7. Behavioral and other non-pharmacological treatments/interventions must be stable for 4 weeks before screening and must remain stable during the period between screening and the commencement of study drug, and throughout the study. Minor changes in hours or times of therapy that are not considered clinically significant will not be exclusionary. Changes in therapies provided through a school program, due to school vacations, are allowed.
  8. Patient must be willing to practice barrier methods of contraception while on study, if sexually active. Abstinence is also considered a reasonable form of birth control in this study population.
  9. Patient has a parent(s), legal authorized guardian(s), or consistent caregiver(s).
  10. Patient and caregiver are able to attend the clinic regularly and reliably.
  11. Patient's parent(s), legal authorized guardian(s), or consistent caregiver(s) is able to understand and sign an informed consent form to participate in the study.
  12. Patient must provide assent for participation in the study if the patient has the cognitive ability to provide assent.
  13. To participate in the Part 1 PK only: patients must be able to swallow capsules.

Patient Exclusion Criteria

  1. Inability to successfully complete the NIH-TCB picture vocabulary and oral reading assessments at screening and baseline for Part 2 (DB). Patient must be able to complete these assessments at baseline to be randomized into Part 2; care should be taken that a patient enrolled into Part 1 (PK) possesses this ability if their desire is to continue to Parts 2 and 3. The ability to complete the NIH-TBC oral reading and picture vocabulary subtest at baseline is defined as the ability to complete both subtests, with (1) confirmation from the clinician administering that the test administrations are valid (noted on the administration form), and (2) generation of valid test scores for each test.
  2. History of, or current cardiovascular, renal, hepatic, respiratory, gastrointestinal, psychiatric, neurologic, cerebrovascular, or other systemic disease that would place the patient at risk or potentially interfere with the interpretation of the safety, tolerability, or efficacy of the study drug.

    • Common conditions such as mild hypertension, etc. are allowed per the PI's judgment as long as they are stable and controlled by medical therapy that is constant for at least 4 weeks before randomization.

  3. Renal impairment, defined as serum creatinine > 1.25 × ULN at screening.
  4. Hepatic impairment, defined as alanine aminotransferase or aspartate aminotransferase elevation > 2 × ULN at screening. Note: liver function tests may be repeated after 1 week to evaluate return to acceptable limits; if liver function tests remain elevated, patient is ineligible to participate.
  5. Clinically significant abnormalities, in the PI's judgment, in safety laboratory tests, vital signs, or 12-lead ECG, as measured during screening.
  6. Positive COVID-19 test during screening.
  7. History of substance abuse within the past year, according to PI's assessment.
  8. Significant hearing or visual impairment that may affect the patient's ability to complete the test procedures.
  9. Concurrent major psychiatric condition (eg, major depressive disorder, schizophrenia, or bipolar disorder) as diagnosed by the PI. Patients with additional diagnosis of autism spectrum disorder or anxiety disorder will be allowed.
  10. Patient has active diseases that would interfere with participation, such as acquired immunodeficiency disorder, hepatitis C, hepatitis B, or tuberculosis.
  11. Patient is an immediate family member of anyone employed by the sponsor, PI, or study staff.
  12. Patient has weight < 60 lbs (27.2 kg) or a BMI greater than the 97th percentile for his age according to the Centers for Disease Control and Prevention (refer to Appendix 1). To participate in the Part 1 cohort receiving 50 mg dose, patient must weigh ≥ 75 lbs (34 kg).
  13. Patient has participated in another clinical trial within the 30 days before screening.

    -

Sites / Locations

  • CHOC Thompson Autism CenterRecruiting
  • UC DavisRecruiting
  • Children's Hospital ColoradoRecruiting
  • Emory University School of Medicine
  • Rush University Medical CenterRecruiting
  • Kennedy KriegerRecruiting
  • U MassRecruiting
  • Seaver Autism Center for Research & Treatment at Mount Sinai
  • Cincinatti Children's Hospital Medical CenterRecruiting
  • Suburban Research AssociatesRecruiting
  • Greenwood Genetic CenterRecruiting
  • University of Utah and Primary Childrens Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Study Drug

Placebo Arm

Arm Description

Subjects will 25mg BID dose of BPN14770

Subjects will receive Placebo

Outcomes

Primary Outcome Measures

NIH Toolbox Cognitive Battery cognition crystallized composite score
The change from baseline to Week 13 in the NIH Toolbox Cognitive Battery cognition crystallized composite score (NIH-TCB CCC), which is calculated from the Picture Vocabulary and Oral Reading domains.

Secondary Outcome Measures

NRS patient-specific behaviors within the domains of Daily Function, Language, and Academic Skills.
Change from baseline to Week 13 in Numerical rating scale (NRS) scores based on patient-specific behaviors within the domains of Daily Function, Language, and Academic Skills.
CaGI-I for the general domains of Daily Function, Language, and Academic Skills.
Change from baseline to Week 13 Caregiver Global Impression of Improvement (CaGI-I) for the general domains of Daily Function, Language, and Academic Skills.
Investigator rated (CGI-I) for the general domains of Daily Function, Language, and Academic Skills
Change from baseline to Week 13 Clinical Global Impression Improvement - Investigator rated (CGI-I) for the general domains of Daily Function, Language, and Academic Skills
NRS scores based on patient-specific behaviors within the domain of Emotions/Behaviors
Change from baseline to Week 13 NRS scores based on patient-specific behaviors within the domain of Emotions/Behaviors
CaGI-I for the general domain of Emotions/Behaviors
Change from baseline to Week 13 CaGI-I for the general domain of Emotions/Behaviors
The NIH-TCB domains of Picture Vocabulary, Oral Reading Recognition, and Pattern Comparison Processing Speed
Change from baseline to Week 13 the NIH-TCB domains of Picture Vocabulary, Oral Reading Recognition, and Pattern Comparison Processing Speed
Vineland-3 Adaptive Behavior Scale (Vineland-3)
Change from baseline to Week 13 Vineland-3 Adaptive Behavior Scale (Vineland-3)
Verbal Knowledge test from the Stanford Binet (ed 5) (SB-5) IQ assessment
Change from baseline Verbal Knowledge test from the Stanford Binet (ed 5) (SB-5) IQ assessment

Full Information

First Posted
December 15, 2021
Last Updated
June 22, 2023
Sponsor
Tetra Discovery Partners
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1. Study Identification

Unique Protocol Identification Number
NCT05163808
Brief Title
A Randomized Study of BPN14770 in Male Adolescents (Aged 12 to < 18 Years) With Fragile X Syndrome
Official Title
A Randomized, Double-blind, Placebo-controlled, Two-Part Study of High and Low Dose BPN14770 in Male Adolescents (Aged 12 to < 18 Years) With Fragile X Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tetra Discovery Partners

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a 2-part study, with each part having a unique set of objectives for male adolescents aged 12 to < 18 years with fragile X syndrome (FXS). Part 1 is an open-label, single-dose, pharmacokinetics (PK) assessment of BPN14770 25 mg and 50 mg, while Part 2 is double-blind (DB) and randomized between two treatment groups (Study Drug and Placebo)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fragile X Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
2 treatment Groups (Study Drug and Placebo)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double Blind
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Drug
Arm Type
Active Comparator
Arm Description
Subjects will 25mg BID dose of BPN14770
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
Subjects will receive Placebo
Intervention Type
Drug
Intervention Name(s)
zatolmilast
Other Intervention Name(s)
BPN14770
Intervention Description
Subjects will receive a low dose, high dose of zatolmilast (BPN14770) or placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
NIH Toolbox Cognitive Battery cognition crystallized composite score
Description
The change from baseline to Week 13 in the NIH Toolbox Cognitive Battery cognition crystallized composite score (NIH-TCB CCC), which is calculated from the Picture Vocabulary and Oral Reading domains.
Time Frame
13 Weeks
Secondary Outcome Measure Information:
Title
NRS patient-specific behaviors within the domains of Daily Function, Language, and Academic Skills.
Description
Change from baseline to Week 13 in Numerical rating scale (NRS) scores based on patient-specific behaviors within the domains of Daily Function, Language, and Academic Skills.
Time Frame
13 Weeks
Title
CaGI-I for the general domains of Daily Function, Language, and Academic Skills.
Description
Change from baseline to Week 13 Caregiver Global Impression of Improvement (CaGI-I) for the general domains of Daily Function, Language, and Academic Skills.
Time Frame
13 Weeks
Title
Investigator rated (CGI-I) for the general domains of Daily Function, Language, and Academic Skills
Description
Change from baseline to Week 13 Clinical Global Impression Improvement - Investigator rated (CGI-I) for the general domains of Daily Function, Language, and Academic Skills
Time Frame
13 Weeks
Title
NRS scores based on patient-specific behaviors within the domain of Emotions/Behaviors
Description
Change from baseline to Week 13 NRS scores based on patient-specific behaviors within the domain of Emotions/Behaviors
Time Frame
13 Weeks
Title
CaGI-I for the general domain of Emotions/Behaviors
Description
Change from baseline to Week 13 CaGI-I for the general domain of Emotions/Behaviors
Time Frame
13 Weeks
Title
The NIH-TCB domains of Picture Vocabulary, Oral Reading Recognition, and Pattern Comparison Processing Speed
Description
Change from baseline to Week 13 the NIH-TCB domains of Picture Vocabulary, Oral Reading Recognition, and Pattern Comparison Processing Speed
Time Frame
13 Weeks
Title
Vineland-3 Adaptive Behavior Scale (Vineland-3)
Description
Change from baseline to Week 13 Vineland-3 Adaptive Behavior Scale (Vineland-3)
Time Frame
13 Weeks
Title
Verbal Knowledge test from the Stanford Binet (ed 5) (SB-5) IQ assessment
Description
Change from baseline Verbal Knowledge test from the Stanford Binet (ed 5) (SB-5) IQ assessment
Time Frame
13 Weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Patient is male adolescent aged 12 to < 18 years. 2. Patient has FXS with a molecular genetic confirmation of the full fragile X mental retardation-1 (FMR1) mutation (≥ 200 CGG repetitions). 3. Current treatment with ≤ 3 prescribed psychotropic medications. Anti-epileptic medications are permitted and are not counted as psychotropic medications if they are used for treatment of seizures. Anti-epileptics for other indications, such as the treatment of mood disorders, count towards the limit of permitted medications. 4. Permitted concomitant psychotropic medications must be at a stable dose and dosing regimen for at least 4 weeks before screening and must remain stable during the period between screening and the commencement of study drug. 5. Anti-epileptic medications must be at a stable dose and dosing regimen for 12 weeks before screening and must remain stable during the period between screening and the commencement of study drug. 6. Patients with a history of seizure disorder who are currently receiving treatment with anti-epileptics must have been seizure-free for 3 months before screening or must be seizure-free for 2 years if not currently receiving anti-epileptics. 7. Behavioral and other non-pharmacological treatments/interventions must be stable for 4 weeks before screening and must remain stable during the period between screening and the commencement of study drug, and throughout the study. Minor changes in hours or times of therapy that are not considered clinically significant will not be exclusionary. Changes in therapies provided through a school program, due to school vacations, are allowed. 8. Patient must be willing to practice barrier methods of contraception while on study, if sexually active. Abstinence is also considered a reasonable form of birth control in this study population. 9. Patient has a parent(s), legal authorized guardian(s), or consistent caregiver(s). 10. Patient and caregiver are able to attend the clinic regularly and reliably. 11. Patient's parent(s), legal authorized guardian(s), or consistent caregiver(s) is able to understand and sign an informed consent form to participate in the study. 12. Patient must provide assent for participation in the study if the patient has the cognitive ability to provide assent. Exclusion Criteria: Diagnosis and main criteria for inclusion: The eligibility criteria are the same for all parts of the study except for Part 1 (PK), where patients must be able to swallow capsules and must weigh at least 75 lbs (34 kg) to receive the 50 mg dose. Patient Inclusion Criteria Patient is male adolescent aged 12 to < 18 years. Patient has FXS with a molecular genetic confirmation of the full fragile X mental retardation-1 (FMR1) mutation (≥ 200 CGG repetitions). Current treatment with ≤ 3 prescribed psychotropic medications. Anti-epileptic medications are permitted and are not counted as psychotropic medications if they are used for treatment of seizures. Anti-epileptics for other indications, such as the treatment of mood disorders, count towards the limit of permitted medications. Permitted concomitant psychotropic medications must be at a stable dose and dosing regimen for at least 4 weeks before screening and must remain stable during the period between screening and the commencement of study drug. Anti-epileptic medications must be at a stable dose and dosing regimen for 12 weeks before screening and must remain stable during the period between screening and the commencement of study drug. Patients with a history of seizure disorder who are currently receiving treatment with anti-epileptics must have been seizure-free for 3 months before screening or must be seizure-free for 2 years if not currently receiving anti-epileptics. Behavioral and other non-pharmacological treatments/interventions must be stable for 4 weeks before screening and must remain stable during the period between screening and the commencement of study drug, and throughout the study. Minor changes in hours or times of therapy that are not considered clinically significant will not be exclusionary. Changes in therapies provided through a school program, due to school vacations, are allowed. Patient must be willing to practice barrier methods of contraception while on study, if sexually active. Abstinence is also considered a reasonable form of birth control in this study population. Patient has a parent(s), legal authorized guardian(s), or consistent caregiver(s). Patient and caregiver are able to attend the clinic regularly and reliably. Patient's parent(s), legal authorized guardian(s), or consistent caregiver(s) is able to understand and sign an informed consent form to participate in the study. Patient must provide assent for participation in the study if the patient has the cognitive ability to provide assent. To participate in the Part 1 PK only: patients must be able to swallow capsules. Patient Exclusion Criteria Inability to successfully complete the NIH-TCB picture vocabulary and oral reading assessments at screening and baseline for Part 2 (DB). Patient must be able to complete these assessments at baseline to be randomized into Part 2; care should be taken that a patient enrolled into Part 1 (PK) possesses this ability if their desire is to continue to Parts 2 and 3. The ability to complete the NIH-TBC oral reading and picture vocabulary subtest at baseline is defined as the ability to complete both subtests, with (1) confirmation from the clinician administering that the test administrations are valid (noted on the administration form), and (2) generation of valid test scores for each test. History of, or current cardiovascular, renal, hepatic, respiratory, gastrointestinal, psychiatric, neurologic, cerebrovascular, or other systemic disease that would place the patient at risk or potentially interfere with the interpretation of the safety, tolerability, or efficacy of the study drug. • Common conditions such as mild hypertension, etc. are allowed per the PI's judgment as long as they are stable and controlled by medical therapy that is constant for at least 4 weeks before randomization. Renal impairment, defined as serum creatinine > 1.25 × ULN at screening. Hepatic impairment, defined as alanine aminotransferase or aspartate aminotransferase elevation > 2 × ULN at screening. Note: liver function tests may be repeated after 1 week to evaluate return to acceptable limits; if liver function tests remain elevated, patient is ineligible to participate. Clinically significant abnormalities, in the PI's judgment, in safety laboratory tests, vital signs, or 12-lead ECG, as measured during screening. Positive COVID-19 test during screening. History of substance abuse within the past year, according to PI's assessment. Significant hearing or visual impairment that may affect the patient's ability to complete the test procedures. Concurrent major psychiatric condition (eg, major depressive disorder, schizophrenia, or bipolar disorder) as diagnosed by the PI. Patients with additional diagnosis of autism spectrum disorder or anxiety disorder will be allowed. Patient has active diseases that would interfere with participation, such as acquired immunodeficiency disorder, hepatitis C, hepatitis B, or tuberculosis. Patient is an immediate family member of anyone employed by the sponsor, PI, or study staff. Patient has weight < 60 lbs (27.2 kg) or a BMI greater than the 97th percentile for his age according to the Centers for Disease Control and Prevention (refer to Appendix 1). To participate in the Part 1 cohort receiving 50 mg dose, patient must weigh ≥ 75 lbs (34 kg). Patient has participated in another clinical trial within the 30 days before screening. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CEO
Phone
616-224-0084
Email
info@tetratherapeutics.com
Facility Information:
Facility Name
CHOC Thompson Autism Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Vasquez
Phone
714-509-4273
Email
Oliver.Vasquez@choc.org
First Name & Middle Initial & Last Name & Degree
Jonathan Megerian, MD
Facility Name
UC Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellery Santos
Phone
916-703-0200
Email
esantos@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Randi Hagerman, MD
Facility Name
Children's Hospital Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sailor Brukardt
Phone
920-810-9347
Email
Sailor.brukardt@childrenscolorado.org
First Name & Middle Initial & Last Name & Degree
Nicole Tartaglia, MD
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30307
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Luan McColl
Phone
404-778-8619
Email
jean.luan@emory.edu
First Name & Middle Initial & Last Name & Degree
Amy Talboy, MD
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loren R Escot
Phone
312-942-2164
Email
Loren_Escot@rush.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth Berry-Kravis, MD,PhD
Facility Name
Kennedy Krieger
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Zapata
Phone
443-923-3868
Email
Zapata@kennedykrieger.org
First Name & Middle Initial & Last Name & Degree
Dejan Budimirovic
Facility Name
U Mass
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arline Mata
Phone
774-455-4100
Email
ChildResearch@umassmed.edu
First Name & Middle Initial & Last Name & Degree
Jean Frazier, MD
Facility Name
Seaver Autism Center for Research & Treatment at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Venus Fan
Phone
929-989-7016
Email
venus.fan@mssm.edu
First Name & Middle Initial & Last Name & Degree
Reymundo Lozano, MD
Facility Name
Cincinatti Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dakota Gallimore
Phone
513-516-2113
Email
Dakota.Gallimore@cchmc.org
First Name & Middle Initial & Last Name & Degree
Ernest Pedapati, MD
Facility Name
Suburban Research Associates
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meghan Varano
Phone
610-891-9024
Ext
1111
Email
mvarano@suburbanresearch.com
First Name & Middle Initial & Last Name & Degree
Hatti, MD
Facility Name
Greenwood Genetic Center
City
Greenwood
State/Province
South Carolina
ZIP/Postal Code
29646
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caleb Hinzman
Phone
864-672-6912
Email
chinzman@ggc.org
First Name & Middle Initial & Last Name & Degree
Caroline Buchanan
Facility Name
University of Utah and Primary Childrens Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carly Straley
Phone
801-598-7509
Email
Carly.Straley@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Victoria Wilkins, MD

12. IPD Sharing Statement

Learn more about this trial

A Randomized Study of BPN14770 in Male Adolescents (Aged 12 to < 18 Years) With Fragile X Syndrome

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