A Phase 2 interventional study of BTD-001 and Placebo in Idiopathic Hypersomnia and Narcolepsy Without Cataplexy, sponsored by Balance Therapeutics. Completed at 23 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-01-16.
Sponsored by Balance Therapeutics · Phase 2, Interventional, and Treatment
Among 30 studies in Idiopathic Hypersomnia with a site in United States — 12 open to participants now, 13 under way, 4 of them phase 3. Idiopathic Hypersomnia · United States.
Among the 30 studies in Idiopathic Hypersomnia with a site in United States, this one is the 11th largest by planned enrollment of the 27 interventional ones, is the only one that started in 2015, is one of 10 in phase 2, and was the 5th registered.
52 studies on the registry are indexed under Idiopathic Hypersomnia; 23 are open to participants now.
This study's planned enrollment of 120 is above the median of 82 across 40 interventional studies indexed under Idiopathic Hypersomnia.
Browse Idiopathic Hypersomnia studies →12 of the 30 studies in Idiopathic Hypersomnia with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 17 Idiopathic Hypersomnia studies recruiting now, 4 (24%) set no upper age limit and 12 (71%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →30 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 1 started in 2015.
Median enrollment 100 across the 27 interventional studies, 100 across the 3 observational. Of the 16 that completed or were terminated, 9 (56%) have results posted.
18 of 30 have an industry lead sponsor. The 10 most frequent:
Balance Therapeutics is the lead sponsor of 4 studies on the registry; none are open to participants now.
Balance Therapeutics has 2 studies filed under Idiopathic Hypersomnia — fewer than ten, so there is no comparison to draw.
5 of the studies in Idiopathic Hypersomnia with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07500090Phase 3Harmony Biosciences Management, Inc.A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH) | 2027-10 |
| NCT06843590Alkermes, Inc.A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia | 2026-11 |
| NCT06812078TakedaA Study of TAK-360 in Adults With Idiopathic Hypersomnia | 2026-11-30 |
| NCT06752668Centessa Pharmaceuticals (UK) LimitedA Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia | 2026-12 |
| NCT05837091Mayo ClinicLow Sodium Oxybate in Patients With Idiopathic Hypersomnia | 2027-01-29 |
Among the 30 studies in Idiopathic Hypersomnia with a site in United States, from their registry updates:
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: BTD-001
Drug: Placebo
Efficacy Epworth Sleepiness Scale
Epworth Sleepiness Scale
Time frame: After 14 days per treatment
Efficacy Maintenance of Wakefulness Test
Maintenance of Wakefulness Test
Time frame: After 14 days per treatment
Pharmacokinetics (Cmax)
Pharmacokinetic parameters after multiple doses. -Maximum serum concentration (Cmax)
Time frame: Selected Days 14, 35, and 56
Pharmacokinetics (Tmax)
Pharmacokinetic parameters after multiple doses. -Time of maximum plasma concentration (Tmax)
Time frame: Selected Days 14, 35, and 56
Pharmacokinetics (T½)
Pharmacokinetic parameters after multiple doses. -Elimination half life (T½)
Time frame: Selected Days 1, 14, 31, 35, 42, and 56
Pharmacokinetics (AUC)
Pharmacokinetic parameters after multiple doses. -Area under the concentration time curve (AUC)
Time frame: Selected Days 1, 14, 21, 35, 42, and 56
Ran from Sep 2015 to primary completion in Feb 2018, 29 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Balance Therapeutics