Study on the Safety and Effectiveness of ALKS 2680 for Patients with Narcolepsy Type 1

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What is this study about?

This clinical trial is focused on studying narcolepsy type 1, a sleep disorder that causes excessive daytime sleepiness and sudden muscle weakness known as cataplexy. The study will evaluate the safety and effectiveness of a new treatment called ALKS 2680, which is taken as a tablet. Participants in the study will receive either ALKS 2680 or a placebo, which looks like the treatment but does not contain the active substance.

The purpose of the study is to assess how well ALKS 2680 works in reducing excessive daytime sleepiness in people with narcolepsy type 1. The study will be conducted over a period of several weeks. During this time, participants will be randomly assigned to different groups to receive varying doses of ALKS 2680 or a placebo. The study will include both a double-blind period, where neither the participants nor the researchers know who is receiving the treatment or placebo, and an open-label period, where all participants will receive ALKS 2680.

Throughout the study, participants will be monitored for changes in their symptoms and any side effects. The study aims to find the most effective dose of ALKS 2680 while ensuring it is safe for use. Participants will have regular check-ups and assessments to track their progress and the impact of the treatment on their narcolepsy symptoms.

1 randomization and initial assessment

Upon joining the study, participants are randomly assigned to receive either the investigational medication ALKS 2680 or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

An initial assessment is conducted to establish baseline measurements. This includes evaluating daytime sleepiness and other symptoms related to narcolepsy type 1.

2 treatment period

Participants take the assigned medication orally in the form of a tablet. The dosage and frequency are determined by the study protocol and may vary among participants.

The treatment period lasts for a specified duration, during which participants continue to take the medication as directed and attend regular study visits for monitoring.

3 monitoring and assessments

Throughout the study, participants undergo regular assessments to monitor the effects of the medication. This includes measuring changes in daytime sleepiness and recording any side effects.

Participants are required to maintain a diary to track symptoms and any episodes of cataplexy, which is a sudden loss of muscle tone.

4 open-label period

After the initial treatment period, participants may enter an open-label phase where all participants receive ALKS 2680. This phase allows for further evaluation of the medication’s effects.

During this period, participants continue to attend study visits and complete assessments as required.

5 final assessment and study completion

At the end of the study, a final assessment is conducted to evaluate the overall effects of the treatment.

Participants are provided with information about the study’s findings and any next steps, if applicable.

Who Can Join the Study?

Must be between 18 and 70 years old.
Must be willing and able to give permission to participate in the study.
Must have a Body Mass Index (BMI) between 18 and 35. BMI is a measure of body fat based on height and weight.
Must have been diagnosed with Narcolepsy Type 1 (NT1) according to specific guidelines, confirmed by tests done in the last 10 years. This includes:
- Having ongoing excessive daytime sleepiness (EDS), shown by a score greater than 10 on a specific sleepiness scale.
- Testing positive for a specific genetic marker or having low levels of a brain chemical called hypocretin-1.
- Experiencing more than 4 episodes of cataplexy (sudden muscle weakness) per week during a specific period.
- Having a mean sleep latency (MSL) of 15 minutes or less during specific tests. MSL is the average time it takes to fall asleep.
Must be willing and able to stop taking any medications for narcolepsy symptoms, including EDS and cataplexy, at least 14 days before the study starts and during the study. If taking antidepressants for narcolepsy, special care is needed when stopping them.
Must be willing and able to follow the study rules, including:
- Following lifestyle guidelines and restrictions.
- Using contraception as advised.
- Completing at least 80% of required activity tracking and diary entries.

Who Cannot Join the Study?

Patients with any other sleep disorder besides Narcolepsy Type 1 cannot participate.
Patients who have a history of drug or alcohol abuse in the past year are not eligible.
Patients with any serious medical condition that might interfere with the study cannot join.
Patients who are pregnant or breastfeeding are not allowed to participate.
Patients who are currently participating in another clinical trial cannot take part in this study.
Patients who have had a major surgery in the past three months are excluded.
Patients with a known allergy to the study medication or its ingredients cannot participate.
Patients who are unable to comply with the study procedures are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Instituto Di Ricovero E Cura A Carattere Scientifico	Bologna	Italy
Epilepsie Instellingen Nederland Stichting	Zwolle	The Netherlands
Pneumocare	Namur	Belgium
Hospital Clinic De Barcelona	Barcelona	Spain
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
San Raffaele Scientific Institute	Milan	Italy
Hospital General Universitario De Castellon	Castello De La Plana	Spain
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Anima	Alken	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	30.08.2024
Czechia	Not recruiting	30.08.2024
France	Not recruiting	30.08.2024
Italy	Not recruiting	30.08.2024
Spain	Not recruiting	30.08.2024
The Netherlands	Not recruiting	30.08.2024

Trial locations

Investigated drugs:

Alks 2680

ALKS 2680 is a medication being studied for its potential to help people with Narcolepsy Type 1, a condition that causes excessive daytime sleepiness. This medication is being tested to see if it can reduce the overwhelming urge to sleep during the day, which is a common problem for people with this condition. The study aims to find out how safe and effective ALKS 2680 is for treating this symptom of narcolepsy.

Investigated diseases:

Narcolepsy

Narcolepsy Type 1 – Narcolepsy Type 1 is a chronic sleep disorder characterized by overwhelming daytime drowsiness and sudden attacks of sleep. It is often accompanied by cataplexy, which is a sudden loss of muscle tone triggered by strong emotions. People with this condition may experience disrupted nighttime sleep and vivid hallucinations as they fall asleep or wake up. Sleep paralysis, a temporary inability to move or speak while falling asleep or upon waking, is also common. The disorder is linked to a deficiency of hypocretin, a brain chemical that regulates wakefulness. Symptoms typically begin in childhood or adolescence and can significantly impact daily activities.

Trial ID:

2024-511112-24-00

Protocol code:

ALKS 2680-201

NCT ID:

NCT06358950

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effectiveness of ALKS 2680 for Patients with Narcolepsy Type 1

What is this study about?

Who Can Join the Study?

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