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NCT Number: NCT02512588

A Study of Safety and Efficacy of BTD-001 in Treatment of Patients With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2

This is a randomized, placebo-controlled, double-blind, multiple cohort, fixed-dose multiple crossover, dose-finding study of oral BTD-001 in adult patients with IH or Narcolepsy without cataplexy (Type 2).

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Key information

Conditions

Idiopathic Hypersomnia Disorders of Excessive Somnolence Dyssomnias Mental Disorders Narcolepsy Without Cataplexy Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sleep Disorders Center of Alabama, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meets ICSD-3 criteria for IH or Narcolepsy Type 2 and not undergoing pharmacologic treatment for the condition
  • Usual nightly total sleep at least 6 hours as single major rest period without naps
  • Epworth Sleepiness Scale of 10 or greater
  • Males or females age 18 to 65 years

Exclusion criteria

  • Any disorder causing hypersomnia other than IH or Narcolepsy Type 2
  • Usual bedtime later than midnight
  • Seizure disorder or history of syncope, unexplained loss of consciousness or seizure in the past 3 years
  • Beck Depression Inventory score greater than 19
  • Beck Anxiety Inventory score greater than 15
  • Significant history of or current suicidal ideation or behavior
  • BMI less than 18 kg/m2 or greater than 39 kg/m2
  • Positive toxicology screen or breathalyzer test
  • Clinically significant abnormal findings on safety assessments
  • Any significant medical or psychiatric disease or any condition that would put the patient at risk by participating in the study

Treatment and study plan

BTD-001

Drug

Placebo

Drug

Primary outcomes

  1. Efficacy Epworth Sleepiness Scale

    Time frame: After 14 days per treatment

    Epworth Sleepiness Scale

Secondary outcomes

  1. Efficacy Maintenance of Wakefulness Test

    Time frame: After 14 days per treatment

    Maintenance of Wakefulness Test

Other outcomes

  1. Pharmacokinetics (Cmax)

    Time frame: Selected Days 14, 35, and 56

    Pharmacokinetic parameters after multiple doses.

    -Maximum serum concentration (Cmax)

  2. Pharmacokinetics (Tmax)

    Time frame: Selected Days 14, 35, and 56

    Pharmacokinetic parameters after multiple doses.

    -Time of maximum plasma concentration (Tmax)

  3. Pharmacokinetics (T½)

    Time frame: Selected Days 1, 14, 31, 35, 42, and 56

    Pharmacokinetic parameters after multiple doses.

    -Elimination half life (T½)

  4. Pharmacokinetics (AUC)

    Time frame: Selected Days 1, 14, 21, 35, 42, and 56

    Pharmacokinetic parameters after multiple doses.

    -Area under the concentration time curve (AUC)

Sponsors and collaborators

Lead sponsor

Balance Therapeutics

Industry

Registry information

Official study title

A Randomized, Placebo-Controlled, Double-blind, Fixed-Dose, Multiple Cohort, Multiple Crossover, Dose-Finding Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 31, 2015
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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