A Multicenter, Open-label, Pilot Study of Soticlestat (TAK-935/OV935) in Participants With 15Q Duplication Syndrome (Dup 15q) or Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder (ARCADE STUDY)
NCT ID: NCT03694275
Last Updated: 2022-05-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2018-09-10
2020-07-31
Brief Summary
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Detailed Description
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The study will enroll approximately 30 participants. Participants will be enrolled into 2 groups based on their diagnosis as: Dup 15q or CDD.
All participants will be asked to take soticlestat tablets twice daily with or without food.
The study comprises of 2 periods: Screening/Baseline Period and Treatment Period (Dose Optimization and Maintenance). The overall time to participate in this study is approximately 30 weeks, including 4 to 6 weeks Screening/Baseline Period, 20 weeks Treatment Period, 2 weeks Taper, and 2 weeks safety follow up period. Participants completing this study will have an option to enroll in the open-label extension (OLE) study, under a separate protocol.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Soticlestat Dup 15q
Soticlestat tablets twice daily (BID) orally or via gastrostomy tube (G-tube)/ percutaneous endoscopic gastrostomy (PEG) tube, BID. Participants with Dup 15q weighing \<60 kg at Baseline received total daily dose of study drug calculated based on body weight. Participants weighing ≥60 kg at Baseline, were administered with 200 mg/day followed by 400 mg/day, then 600 mg/day, up to Week 20.
Soticlestat
TAK-935 tablets
Soticlestat CDD
Soticlestat tablets BID orally or via G-tube/ PEG tube, BID. Participants with CDD weighing \<60 kg at Baseline received total daily dose of study drug calculated based on body weight. Participants weighing ≥60 kg at Baseline, were administered with 200 mg/day followed by 400 mg/day, then 600 mg/day, up to Week 20.
Soticlestat
TAK-935 tablets
Interventions
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Soticlestat
TAK-935 tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Currently taking 1 to 6 antiepileptic drugs (AEDs) at a stable dose.
Exclusion Criteria
2. Currently receiving a study drug or participated in a clinical study involving another investigational product in the previous month.
2 Years
55 Years
ALL
No
Sponsors
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Healx AI
INDUSTRY
Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director Clinical Science
Role: STUDY_DIRECTOR
Takeda
Locations
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UCLA
Los Angeles, California, United States
Research Institute Children's Hospital Colorado
Aurora, Colorado, United States
Center for Rare Neurological Diseases
Norcross, Georgia, United States
Center for Rare Neurological Diseases (CRND)--Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Children's Hospital Translational Neuroscience Center
Boston, Massachusetts, United States
Minnesota Epilepsy Group, P.A.
Saint Paul, Minnesota, United States
New York University (NYU)
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Countries
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References
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Demarest S, Jeste S, Agarwal N, Arkilo D, Asgharnejad M, Hsiao S, Thibert R. Efficacy, safety, and tolerability of soticlestat as adjunctive therapy for the treatment of seizures in patients with Dup15q syndrome or CDKL5 deficiency disorder in an open-label signal-finding phase II study (ARCADE). Epilepsy Behav. 2023 May;142:109173. doi: 10.1016/j.yebeh.2023.109173. Epub 2023 Apr 1.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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U1111-1219-5787
Identifier Type: REGISTRY
Identifier Source: secondary_id
2022-001315-44
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TAK-935-18-002 (OV935)
Identifier Type: -
Identifier Source: org_study_id
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