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EVT 201

Phase 2

Sleep Initiation and Maintenance Disorders | Small molecule | Psychiatry |Evotec SE|Last Updated: Jan 30, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment201

FDA Designations

No designations recorded

Clinical trial landscape

EVT 201 · 2 trials · 1 indication

Phase 2 2
NCT00401284Efficacy Study of EVT 201 in the Treatment of Elderly Patients With Daytime SleepinessSleep Initiation and Maintenance Disorders
COMPLETED135 Analytics
NCT00380003Efficacy Study of EVT 201 to Treat InsomniaSleep Initiation and Maintenance Disorders
COMPLETED66 Analytics
PHASE2COMPLETED
Efficacy Study of EVT 201 in the Treatment of Elderly Patients With Daytime Sleepiness
Sleep Initiation and Maintenance DisordersUnlock trial analytics
PHASE2COMPLETED
Efficacy Study of EVT 201 to Treat Insomnia
Sleep Initiation and Maintenance DisordersUnlock trial analytics

Study Endpoints

Primary Endpoints

Polysomnography derived Total Sleep Time averaged over nights 1, 6 and 7
Total Sleep Time
Wake after sleep onset

Secondary Endpoints

Mean Multiple Sleep Latency Test at Day 8
Mean Psychomotor Vigilance Task at Day 8
Mean Karolinska Sleepiness Scale at Day 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
EVT 201DRUG -
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Eligibility Criteria

Age Range65 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: * Diagnosis of primary insomnia according to DSM-IV * Over the last three months for at least 5 nights per week, must have a normal bedtime of between 9 pm and 1 am and a time in bed of at least 7 hours * A history of sleepiness, tiredness or unintentional napping during the day...

Countries:United States
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Frequently asked questions about EVT 201

What is EVT 201 used for?

EVT 201 is an investigational small molecule being developed for sleep initiation and maintenance disorders, a class of conditions that includes insomnia. It is being studied in patients who have difficulty falling asleep or staying asleep. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes EVT 201?

EVT 201 is being developed by Evotec SE, a biopharmaceutical company traded on the stock exchange under the ticker EVO. The company is conducting clinical trials to evaluate the drug's safety and efficacy for the treatment of sleep initiation and maintenance disorders.

What phase is EVT 201 in?

EVT 201 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies such as the FDA. The drug is being studied for its potential to treat sleep initiation and maintenance disorders, including insomnia.

What clinical trials is EVT 201 in?

EVT 201 has been studied in two completed Phase 2 clinical trials. The first trial, NCT00380003, enrolled 66 adults aged 21 and older to evaluate the drug's efficacy in treating insomnia. The second trial, NCT00401284, enrolled 135 elderly patients aged 65 and older to assess the drug's effects on daytime sleepiness.

Is EVT 201 the same as any other drug?

EVT 201 is the primary name used for this investigational drug in clinical trials and development. No alternative names have been reported for this compound. It is a small molecule being developed by Evotec SE for the treatment of sleep initiation and maintenance disorders.