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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02512588

Enrollment

120

Registered

2015-07-31

Start date

2015-09-30

Completion date

2018-02-28

Last updated

2019-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Hypersomnia, Narcolepsy Without Cataplexy

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).

Interventions

DRUGBTD-001

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Efficacy Epworth Sleepiness Scale	After 14 days per treatment	Epworth Sleepiness Scale

Secondary

Measure	Time frame	Description
Efficacy Maintenance of Wakefulness Test	After 14 days per treatment	Maintenance of Wakefulness Test

Other

Measure	Time frame	Description
Pharmacokinetics (Cmax)	Selected Days 14, 35, and 56	Pharmacokinetic parameters after multiple doses. -Maximum serum concentration (Cmax)
Pharmacokinetics (Tmax)	Selected Days 14, 35, and 56	Pharmacokinetic parameters after multiple doses. -Time of maximum plasma concentration (Tmax)
Pharmacokinetics (T½)	Selected Days 1, 14, 31, 35, 42, and 56	Pharmacokinetic parameters after multiple doses. -Elimination half life (T½)
Pharmacokinetics (AUC)	Selected Days 1, 14, 21, 35, 42, and 56	Pharmacokinetic parameters after multiple doses. -Area under the concentration time curve (AUC)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026