The Clinical Trials Unit at Kennedy Krieger focuses on studies of many disorders in the medical and mental health field.
Currently Recruiting Trials
Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy (Neurocrine)
This study is currently recruiting
Description: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy (Neurocrine).
Eligibility & Criteria
IRB #: IRB00391760
Principal Investigator: Heather Riordan, MD
Eligible Age Range: All
Gender: All
Diagnosis: Children and adults with Dyskinetic Cerebral Palsy
Click here to view study flyer.
The Balance Study – Bipolar Disorder (Allergan)
This study is currently recruiting
Description: Bipolar depression can change the way a child or teen interacts with the world around them. If you or your child have bipolar depression, we are inviting you to take part in the Balance Study for children and teens, aged 10 to 17 years of age, who have been struggling with bipolar depression. The purpose of this study is to evaluate an investigational drug for bipolar depression in children and teens. The Balance Study will enroll about 380 children and teens with bipolar depression at participating study centers throughout North America and Europe.
Eligibility & Criteria
IRB #: IRB00281389
Principal Investigator: Bradley Grant, DO
Eligible Age Range: 10 - 17 years
Gender: All
Diagnosis: Bipolar Disorder
Click here to view study flyer.
A Randomized, Double-Blind, Placebo-Controlled Study in Male Adolescents with Fragile X Syndrome (TETRA 204)
This study is currently recruiting
Description: A Randomized, Double-Blind, Placebo-Controlled, Two-Part Study of BPN14770 in Male Adolescents (Aged 9 To <18 Years) with Fragile X Syndrome.
Eligibility & Criteria
IRB #: IRB00312157
Principal Investigator: Dejan B. Budimirovic, MD
Eligible Age Range: 12 to 18 years
Gender: Male only
Diagnosis: Fragile X Syndrome
A Randomized, Double-Blind, Placebo-Controlled Study in Male Adults with Fragile X Syndrome (TETRA 301)
This study is currently recruiting
Description: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study ofBPN14770 in Male Adults (Aged 18 to 45) with Fragile X Syndrome.
Eligibility & Criteria
IRB #: IRB00353081
Principal Investigator: Dejan B. Budimirovic, MD
Eligible Age Range: 18 to 45 years
Gender: Male Only
Diagnosis: Fragile X Syndrome
ZYN002 Administered as a Transdermal Gel to Children, Adolescents, and Young Adults for Treatment of Fragile X Syndrome
This study is currently recruiting
Description: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children, Adolescents, and Young Adults with Fragile X Syndrome – RECONNECT
Eligibility & Criteria
IRB #: IRB00281916
Principal Investigator: Dejan B. Budimirovic, MD
Eligible Age Range: Children, Adolescents, and Young Adults
Gender: All
Diagnosis: Fragile X Syndrome
Forward-March Fragile X Study
This study is currently recruiting
Description: FORWARD-MARCH is the next step following a highly successful research study called FORWARD (Fragile X Online Registry With Accessible Research Database) that was started in 2012. The FORWARD study created the largest database of information on fragile X syndrome (FXS) in the United States. Data from the FORWARD study is being used by researchers to learn about the lives of people with FXS, including medication use, behaviors, and development over time, and share findings with other researchers and clinicians.
Eligibility & Criteria
IRB #: 00337864
Principal Investigator: Dejan B. Budimirovic, MD
Eligible Age Range: Individuals born between 2003-2017
Gender: All
Diagnosis: Fragile X Syndrome
Amgen Osteogenesis Imperfecta Study
Description: A Phase 3, Open-label, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Romosozumab Compared with Bisphosphates in Children and Adolescents with Osteogenesis Imperfecta
Eligibility & Criteria
IRB #: IRB00397371
Principal Investigator: Malinda Wu, MD
Eligible Age Range: 5 to 18
Gender: All
Diagnosis: Osteogenesis Imperfecta
Multimodal brain imaging of the neural effects of methylphenidate in patients with ADHD
Description: This research study is being conducted to evaluate how the study drug, methylphenidate, affects brain activity and brain chemistry in righthanded children ages 6-17 years with ADHD. The study consists of three onsite visits and involves neuropsychological testing along with functional MRI and magnetic resonance spectroscopy (MRS) scans after a single dose of each treatment (i.e., placebo, low dose of methylphenidate, and higher dose). Eligible participants may earn up to $300 for completing the study.
Eligibility & Criteria
IRB #: IRB00276357
Principal Investigator: Bradley Grant, DO
Eligible Age Range: 6 to 17 years
Gender: All
Diagnosis: ADHD
Guanfacine for Hyperactivity in Children with Down Syndrome (HYP01; HYPEbeGONE_DS)
This study is currently recruiting.
Description: This research study is being conducted to determine the efficacy of guanfacine immediate release (GIR) for the treatment of hyperactivity/impulsivity and inattention in children with Down Syndrome (DS) ages 6-12 years old after 8 weeks of treatment.
Eligibility & Criteria
IRB #: IRB00435979
Principal Investigator: George Capone, MD
Eligible Age Range: 6 to 12 years Gender: All
Diagnosis: Non-mosaic Down Syndrome, ADHD symptoms
Cerebral Adrenoleukodystrophy (CALYX)
This study is currently recruiting.
Description: A Clinical Study to Assess the Efficacy and Safety of Leriglitazone in Adult Male Subjects with Cerebral Adrenoleukodystrophy
Eligibility & Criteria IRB #: IRB00382750
Principal Investigator: Eric Mallack, MD
Eligible Age Range: 18+ Gender: Male
Diagnosis: Cerebral Adrenoleukodystrophy
Active, but not enrolling:
A Phase 1b, Single Ascending Dose, Randomized, Double-Blind Study to Evaluate SAR439459 for the Treatment of Osteogenesis Imperfecta in Adults
This study is not currently recruiting
Eligibility & Criteria
IRB #: IRB00316494
Principal Investigator: Malinda Wu, MD
Eligible Age Range: 18 years and older
Diagnosis: Osteogenesis Imperfecta
Ultragenyx Study to Assess the Efficacy and Safety of Setrusumab in Subjects with Osteogenesis Imperfecta
Description: An Operationally Seamless, Randomized Phase 2/3 Study Consisting of a Phase 2 Single-Blind, Dose-Evaluation Phase and Phase 3 Double-Blind, Placebo-Controlled Phase to Assess The Efficacy and Safety of Setrusumab in Subjects with Osteogenesis Imperfecta (ULTRAGENYX)
IRB #: IRB00316439
Principal Investigator: Malinda Wu, MD
Eligible Age Range: Ages 5 to 26
Gender: All
Diagnosis: Osteogenesis Imperfecta
Epidiolex® For the Treatment Of Anxiety Comorbidity In Refractory Pediatric Epilepsy (EAPE)
This study is not currently recruiting
Description: This research study titled, Epidiolex® For the Treatment Of Anxiety Comorbidity In Refractory Pediatric Epilepsy (EAPE), is being conducted by Dr. Jay Salpekar to evaluate if the drug FDA approved drug, Epidiolex®, helps control anxiety and mood symptoms associated with recurrent seizures in addition to seizure control. The length of the study is 4 months and consists of 11 visits; some are remote and some are onsite.
If you or a family member have any questions or are interested in learning more about the study please contact the study staff by replying to this notice or by contacting the staff directly with the information below.
Eligibility & Criteria
IRB #: IRB00282248
Principal Investigator: Dr. Jay Salpekar
Eligible Age Range: 6-17 years
Gender: All
Diagnosis: Anxiety, Anxiety Disorder, Epilepsy, Seizures
Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)
This study is not currently recruiting
Description: I-ACQUIRE, a form of constraint-induced movement therapy (CIMT), is being evaluated - in two dosages – compated to typical treatments for children with hemiparesis, such as one hour weekly each of occupational therapy and physical therapy. Both dosages involve therapy fice days a week for four consecutive weeks, provided by a therapist trained in I-ACQUIRE. You’re infant or toddler may be eligible if he or she had a stroke very early in life and shows motor weakness or poor movement control on one side (hemiparesis.
Eligibility & Criteria
IRB #: IRB00219451
Principal Investigator: Dr. Joan Carney
Eligible Age Range: 8 months-36 months
Gender: All
Diagnosis: Perinatal Arterial Ischemic Stroke (PAIS)
Contact Us
1741 Ashland Avenue
Baltimore, MD 21205
Phone: (443) 923-3850
Email: ResearchTrials@KennedyKrieger.org
Participate in Research
To learn more about open research studies at Kennedy Krieger Institute, please visit our Participate in Research page.