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

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ClinicalTrials.gov Identifier: NCT02512588
Recruitment Status : Active, not recruiting
First Posted : July 31, 2015
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Balance Therapeutics

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Idiopathic Hypersomnia Narcolepsy Without Cataplexy Drug: BTD-001 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2015
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BTD-001 Drug: BTD-001
Experimental: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Efficacy Epworth Sleepiness Scale [ Time Frame: After 14 days per treatment ]
    Epworth Sleepiness Scale


Secondary Outcome Measures :
  1. Efficacy Maintenance of Wakefulness Test [ Time Frame: After 14 days per treatment ]
    Maintenance of Wakefulness Test


Other Outcome Measures:
  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)




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02512588


  Show 23 Study Locations
Sponsors and Collaborators
Balance Therapeutics
Investigators
Study Director: Lyndon Lien, PhD Balance Therapeutics, Inc.

Additional Information:
Responsible Party: Balance Therapeutics
ClinicalTrials.gov Identifier: NCT02512588     History of Changes
Other Study ID Numbers: BTD-001 IH201
First Posted: July 31, 2015    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Narcolepsy
Disorders of Excessive Somnolence
Cataplexy
Hypersomnolence, Idiopathic
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders