What side effects are associated with this type of intervention?

Pitolisant, a Histamine H3 Receptor Antagonist/Inverse Agonist, is being studied for its long-term safety and effectiveness in treating Idiopathic Hypersomnia. Common side effects of similar treatments may include headache, insomnia, nausea, anxiety, and dizziness. Other treatments for Idiopathic Hypersomnia, such as modafinil and armodafinil, can also cause side effects like nervousness, dry mouth, and gastrointestinal disturbances. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

Pitolisant is a Histamine H3 Receptor Antagonist/Inverse Agonist that has been studied for its effectiveness in treating Idiopathic Hypersomnia. While specific FDA approvals for Pitolisant in the context of Idiopathic Hypersomnia are not detailed, it is known for its use in treating narcolepsy. Other treatments for hypersomnia often include stimulants like modafinil and armodafinil, which are approved for narcolepsy and sleep apnea but are also used off-label for Idiopathic Hypersomnia. Sodium oxybate is another drug approved for narcolepsy that may be used off-label for Idiopathic Hypersomnia.

What other types of research exist?

Promising alternatives to Pitolisant for Idiopathic Hypersomnia patients may include Modafinil or Armodafinil, which are used to treat excessive daytime sleepiness in various sleep disorders. Consulting with a healthcare provider for personalized treatment options is recommended.

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Histamine 3 Receptor Antagonist

Pitolisant for Idiopathic Hypersomnia

Phase 3

Waitlist Available

Research Sponsored by Harmony Biosciences, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 3 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing the safety and effectiveness of pitolisant, a medication that helps people stay awake, in adults with idiopathic hypersomnia. These patients have already completed an earlier part of the study. Pitolisant works by boosting brain chemicals that make you feel more alert. It has been approved for the treatment of narcolepsy in adults.

Who is the study for?

This trial is for adults with idiopathic hypersomnia who finished the prior study phase (HBS-101-CL-010) and can follow the study plan. Participants must not use certain drugs, have severe kidney or liver issues, or be at significant suicide risk. Women of childbearing age must test negative for pregnancy and agree to avoid pregnancy during the study.

What is being tested?

The trial is evaluating the long-term safety and effectiveness of a medication called pitolisant in patients with excessive daytime sleepiness due to idiopathic hypersomnia, following their participation in an earlier phase of research.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions to pitolisant throughout the trial to assess its long-term safety profile.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Excessive daytime sleepiness

Safety and tolerability of pitolisant

Secondary study objectives

Functional outcomes of sleep

Sleep inertia

Sleep related impairments during wakefulness

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PitolisantExperimental Treatment1 Intervention

Week 1: 8.9 mg pitolisant administered once daily in the morning upon wakening; Week 2: 17.8 mg pitolisant administered once daily in the morning upon wakening; Weeks 3 through end of treatment: 17.8 mg to 35.6 mg pitolisant administered once daily in the morning upon wakening.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pitolisant

2016

Completed Phase 3

~400

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Histamine H3 receptor antagonists/inverse agonists, such as Pitolisant, work by blocking H3 receptors in the brain, which leads to increased release of histamine and other neurotransmitters like dopamine and norepinephrine. This action enhances wakefulness and reduces excessive daytime sleepiness, addressing the core symptoms of Idiopathic Hypersomnia. This mechanism is crucial for IH patients as it directly targets the neurochemical imbalances that cause their debilitating symptoms, thereby improving their overall quality of life.

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