CompletedPhase 2

Placebo-Controlled, Double-Blind, Study to Determine the Safety and Efficacy of SDX in Patients With IH

United States50 participantsStarted 2022-12-28

Plain-language summary

This is a study of the safety, efficacy and pharmacokinetics (PK) of Serdexmethylphenidate (SDX) compared to placebo in subjects with Idiopathic Hypersomnia (IH).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. At least 18 years of age at the time of consent
✓. Body Mass Index (BMI) ≤35 kg/m2
✓. Documented primary diagnosis of IH according to the International Classification of Sleep Disorders (ICSD-3) criteria
✓. At the Screening Visit and Baseline Visit (start of OLTP), Epworth Sleepiness Scale (ESS) scores ≥11
✓. Average nightly Total Sleep Time (TST) of ≥7 hours, per subject history and confirmed during screening.
✓. Subject must be in general good health defined as the absence of any clinically relevant abnormalities as determined by the Investigator based on physical and neurological examinations, vital signs, ECGs, medical history, and clinical laboratory values (hematology, chemistry, and urinalysis) at Screening.
✓. If currently treated with nicotine replacement therapy, must have been taking the same regimen and dose for at least 2 months prior to screening and must agree to take the same dose during the study.
✓. Have used a medically acceptable method of contraception for at least 2 months prior to the first dose of study drug and consent to use a medically acceptable method of contraception from the first dose of study drug, throughout the entire study period, and for 90 days after the last dose of study drug.

Exclusion criteria

✕. Hypersomnia due to another medical, behavioral, or psychiatric disorder condition (eg, narcolepsy, depression disorders, multiple sclerosis, Parkinson's disease, stroke).
✕. Clinically significant sleep-related breathing disorders, including sleep apnea, treatment with Continuous Positive Airway Pressure (CPAP) therapy, Obstructive Apnea Hypopnea Index (AHI) \>15 episodes per hour, or hypoventilation.
✕. Clinically significant parasomnias (eg, sleep walking, rapid eye movement \[REM\] sleep behavior disorder, etc).
✕. Periodic Limb Movement Disorder (PLMD) Arousal Index (PLMA-I) \>15 during Screening PSG, a historical diagnosis of PLMD (last 10 years), or a PLMD diagnosis older than 10 years with current (last 60 days) treatment or symptoms of rhythmic movements involving one or both legs during sleep.
✕. Occupation requiring nighttime shift work or variable shift work with early work start times (before 6 AM), if this occurs more than once per week.
✕. Planned travel during the study that includes more than 3 time zones, or planned travel that includes 3 time zones on more than 2 occasions during the study.
✕. Going to sleep for the night later than 1 AM at a frequency of more than once per week.
✕. Current or past (within 1 year) major depressive episode according to DSM-5 criteria.

What they're measuring

Safety parameters - TEAEs

Timeframe: Time Frame: Start of OLTP to end of DBWP (7 weeks)

Safety parameter - Heart Rate

Timeframe: Time Frame: Start of OLTP to end of DBWP (7 weeks)

Safety parameter - Blood Pressure

Timeframe: Time Frame: Start of OLTP to end of DBWP (7 weeks)

Safety parameter - Laboratory Tests

Timeframe: Time Frame: Start of OLTP to end of DBWP (7 weeks)

Safety parameter - ECG

Timeframe: Time Frame: Start of OLTP to end of DBWP (7 weeks)

Safety parameter - PSQI

Timeframe: Time Frame: Start of OLTP to end of DBWP (7 weeks)

Trial details

NCT IDNCT05668754

SponsorZevra Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-28

View on ClinicalTrials.gov More Idiopathic Hypersomnia trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. At least 18 years of age at the time of consent
✓. Body Mass Index (BMI) ≤35 kg/m2
✓. Documented primary diagnosis of IH according to the International Classification of Sleep Disorders (ICSD-3) criteria
✓. At the Screening Visit and Baseline Visit (start of OLTP), Epworth Sleepiness Scale (ESS) scores ≥11
✓. Average nightly Total Sleep Time (TST) of ≥7 hours, per subject history and confirmed during screening.
✓. Subject must be in general good health defined as the absence of any clinically relevant abnormalities as determined by the Investigator based on physical and neurological examinations, vital signs, ECGs, medical history, and clinical laboratory values (hematology, chemistry, and urinalysis) at Screening.
✓. If currently treated with nicotine replacement therapy, must have been taking the same regimen and dose for at least 2 months prior to screening and must agree to take the same dose during the study.
✓. Have used a medically acceptable method of contraception for at least 2 months prior to the first dose of study drug and consent to use a medically acceptable method of contraception from the first dose of study drug, throughout the entire study period, and for 90 days after the last dose of study drug.

Exclusion criteria

✕. Hypersomnia due to another medical, behavioral, or psychiatric disorder condition (eg, narcolepsy, depression disorders, multiple sclerosis, Parkinson's disease, stroke).
✕. Clinically significant sleep-related breathing disorders, including sleep apnea, treatment with Continuous Positive Airway Pressure (CPAP) therapy, Obstructive Apnea Hypopnea Index (AHI) \>15 episodes per hour, or hypoventilation.
✕. Clinically significant parasomnias (eg, sleep walking, rapid eye movement \[REM\] sleep behavior disorder, etc).
✕. Periodic Limb Movement Disorder (PLMD) Arousal Index (PLMA-I) \>15 during Screening PSG, a historical diagnosis of PLMD (last 10 years), or a PLMD diagnosis older than 10 years with current (last 60 days) treatment or symptoms of rhythmic movements involving one or both legs during sleep.
✕. Occupation requiring nighttime shift work or variable shift work with early work start times (before 6 AM), if this occurs more than once per week.
✕. Planned travel during the study that includes more than 3 time zones, or planned travel that includes 3 time zones on more than 2 occasions during the study.
✕. Going to sleep for the night later than 1 AM at a frequency of more than once per week.
✕. Current or past (within 1 year) major depressive episode according to DSM-5 criteria.

What they're measuring

Safety parameters - TEAEs

Timeframe: Time Frame: Start of OLTP to end of DBWP (7 weeks)

Safety parameter - Heart Rate

Timeframe: Time Frame: Start of OLTP to end of DBWP (7 weeks)

Safety parameter - Blood Pressure

Timeframe: Time Frame: Start of OLTP to end of DBWP (7 weeks)

Safety parameter - Laboratory Tests

Timeframe: Time Frame: Start of OLTP to end of DBWP (7 weeks)

Safety parameter - ECG

Timeframe: Time Frame: Start of OLTP to end of DBWP (7 weeks)

Safety parameter - PSQI

Timeframe: Time Frame: Start of OLTP to end of DBWP (7 weeks)