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NarcolepsyPhase 2NCT02821715

Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients

A Phase 2 study testing THN102 300/3 and THN102 300/27 in people with Narcolepsy, run by Theranexus at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This Phase 2 study is a 8-site, double-blind, randomised, placebo-controlled, 3-way cross-over trial, involving 3 treatments with Modafinil 300 mg or the combination drug THN102 (Modafinil/Flecainide 300 /3 mg, Modafinil/Flecainide 300 /27 mg). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Narcolepsy
What is being tested?
THN102 300/3 and THN102 300/27
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
51 participants
Where
8 sitesin 2 countries
Study dates
Sep 2016to Feb 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Main inclusion Criteria:

  • Patients with a diagnosis of narcolepsy type 1 (i.e. with cataplexy) or type 2 (without cataplexy) according to the International Classification of Sleep Disorders (ICSD-3) criteria.
  • Body mass index >18 kg/m2 and <35 kg/m2.
  • Patients treated with modafinil at stable dosage for at least 2 months and still complaining of excessive daily somnolence (EDS) despite the treatment
  • Epworth Sleepiness Scale (ESS) score should be ≥ 14/24 during the baseline period.

Main exclusion Criteria:

  • Patients with an untreated sleep apnea syndrome (respiratory disorder index > 30/h) or who have any other cause of daytime sleepiness as assessed on patient history.
  • Psychiatric and neurological disorders, other than narcolepsy/cataplexy, such as Parkinson's disease, Alzheimer's disease, Huntington's Chorea, multiple sclerosis, moderate or severe psychosis or dementia, bipolar illness, epilepsy, severe clinical anxiety or depression, Beck Depression Inventory ≥ 21 or with suicidal risk (if item > 0), or other problem that in the investigator's opinion would preclude the patient's participation and completion of this trial or comprise reliable representation of subjective symptoms.
  • Contraindication to flecainide

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

France7 sites

  • CHU Pellegrin

    Bordeaux, 33076

  • CHU Dijon Bourgogne

    Dijon

  • Hôpital Raymond Poincaré

    Garches, 92380

  • CHU Grenoble Alpes

    Grenoble

  • CHRU Lilles

    Lille, 59037

  • University Hospital

    Montpellier, 34090

  • Groupe Hospitalier Pitié Salpêtrière

    Paris, 75013

Other trials in France

Belgium1 site

  • RespiSom

    Erpent

Other trials in Belgium

About this study

This Phase 2 study is a 8-site, double-blind, randomised, placebo-controlled, 3-way cross-over trial, involving 3 treatments with Modafinil 300 mg or the combination drug THN102 (Modafinil/Flecainide 300 /3 mg, Modafinil/Flecainide 300 /27 mg).

Read the detailed description

The 3 double blind periods (2-week) follow a stabilisation period for modafinil at 300 mg/day (open, 2-week) and are followed by a one-week washout period with the same modafinil dose.

Conditions
Narcolepsy
Being tested
Active comparator: Modafinil + placebo, THN102 300/3, THN102 300/27
Medical subject headings
Narcolepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active comparator: Modafinil + placeboDrug

    Also called Modafinil 300 mg, Flecainide Placebo

  • THN102 300/3Drug

    Also called Modafinil 300 mg, Flecainide 3 mg

  • THN102 300/27Drug

    Also called Modafinil 300 mg, Flecainide 27 mg

Study groups in NCT02821715
Study groupRoleWhat they receive
Modafinil + placeboActive comparator3 tablets modafinil 100 mg per day and 3 capsules flecainide placebo per day for 2 weeks
Receives: Drug: Active comparator: Modafinil + placebo
THN102 300/3Experimental3 tablets modafinil 100 mg per day and 3 capsules flecainide 1 mg per day (THN102 as 300 + 3 mg) for 2 weeks
Receives: Drug: THN102 300/3
THN102 300/27Experimental3 tablets modafinil 100 mg per day and 3 capsules flecainide 9 mg per day(THN102 as 300 + 27 mg) for 2 weeks
Receives: Drug: THN102 300/27

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Epworth Sleepiness Scale (ESS)

    Range 0 to 24, low score indicates good outcome

    Measured: 14 days after the beginning of treatment period

Secondary outcomes (12)

  1. 14-item Fatigue Scale

    Fatigue scale is a rating scale completed by the participants at each visit starting from baseline to last visit; 14 questions to be ticked off by "yes" or "No" by the patient. 0 : No fatigue 14 : worst fatigue condition

    Measured: 14 days after the beginning of treatment period

  2. Questionnaire EQ-5D (European Quality of Life EQ-5D) (Questionnaire Part)

    EQ-5D is a quality of life questionnaire filled in by the participants from screening to the last visit (all visits).

    The EQ-5D assesses the status on the day of visit and not over the past week. It has two parts:

    The first part is a descriptive system that assesses five distinct health states/dimensions: Mobility (MO), Self-care (SC), Usual activities (UA), Pain/discomfort, Anxiety/depression (AD). A higher score signifies a higher number of symptoms present.

    The second part is a 100 mm VAS (EQ-VAS). An increase in VAS indicates an improvement in health state.

    Measured: 14 days after the beginning of the screening

  3. Patient Global Impression of Change (PGI-C)

    PGI-C is a scale completed by the participants starting from screening to last Last visit (all the visits).

    Participants have to chose 1 condition among 7 : Very much improved/ Much improved/ Minimally improved/ No change/ Minimally worse/ Much worse/ Very much worse.

    1 is the best score (very much improved) 7 is the worse score (very much worse)

    Measured: 14 days after the beginning of treatment period

  4. Clinical Global Impression of Change (CGI-C) Global Impression

    CGI-C (change from baseline) is a scale completed by the investigator at V3, V4 , V5 and V6 for global impression the investigator or his/her designee has to score 3 items : global impression/ sleepiness and Cataplexy.

    For each item the investigator or his/her designee has to chose 1 condition among 7 : Very much improved/ Much improved/ Minimally improved/ No change/ Minimally worse/ Much worse/ Very much worse.

    1 is the best score (very much improved) 7 is the worse score (very much worse)

    Measured: 14 days after the end of treatment period I

  5. Beck Depression Inventory (BDI)

    Beck Depression Inventory (BDI) evaluation for depressive symptoms (including suicidal thoughts). The scale is completed by the participants from baseline, to last visit (all except screening visit). The questionnaire contains 21 items. Each must be scored from 0 to 3, minimum score = 0, maximum score = 63. A high score indicates increased severity of depression.

    Measured: 14 days

  6. Patient Global Impression for Severity (PGI-S) Global Score

    PGI-S us a scale filled by the participant from screening to last visit (all the visits) Participants have to chose 1 condition among 7 : 1 Normal-Not ill at all/ 2 borderline ill/ 3 mildly ill/ 4 moderately ill/ 5 markedly ill/ 6 severely ill/ 7 among the most extremely ill patient

    1 is the best score (very much improved) 7 is the worse score (very much worse)

    Measured: 14 days

  7. Clinical Global Impression of Change (CGI-C) Sleepiness

    CGI-C (change from baseline) is a scale completed by the investigator at V3, V4 , V5 and V6 for sleepiness

    the investigator or his/her designee has to score 3 items : global impression/ sleepiness and Cataplexy.

    For each item the investigator or his/her designee has to chose 1 condition among 7 : Very much improved/ Much improved/ Minimally improved/ No change/ Minimally worse/ Much worse/ Very much worse.

    1 is the best score (very much improved) 7 is the worse score (very much worse)

    Measured: 14 days after the end of treatment period I

  8. Clinical Global Impression of Change (CGI-C) Cataplexy

    CGI-C (change from baseline) is a scale completed by the investigator at V3, V4 , V5 and V6 for Cataplexy

    the investigator or his/her designee has to score 3 items : global impression/ sleepiness and Cataplexy.

    For each item the investigator or his/her designee has to chose 1 condition among 7 : Very much improved/ Much improved/ Minimally improved/ No change/ Minimally worse/ Much worse/ Very much worse.

    1 is the best score (very much improved) 7 is the worse score (very much worse)

    Measured: 14 days after the end of treatment period I

  9. Clinical Global Impression for Severity (CGI-S) Global Score

    CGI-S is a scale completed by the investigator at each visit : Item global impression

    CGI-S us a scale filled by the Investigator or his/her designee from screening to last visit (all the visits) Investigators have to chose 1 condition among 7 : 1 normal-not ill at all/ 2 borderline ill/ 3 mildly ill/ 4 moderately ill/ 5 markedly ill/ 6 severely ill/ 7 among hte most extremely ill patient

    1 is the best score (very much improved) 7 is the worse score (very much worse)

    CGI-S scale explores 3 items : Global impression/ Sleepiness/ Cataplexy

    Measured: 14 days after the end of treatment period I

  10. Clinical Global Impression for Severity (CGI-S) Sleepiness

    CGI-S is a scale completed by the investigator at each visit for Sleepiness

    CGI-S us a scale filled by the Investigator or his/her designee from screening to last visit (all the visits) Investigators have to chose 1 condition among 7 : 1 Normal-Not ill at all/ 2 Borderline ill/ 3 Mildly ill/ 4 Moderately ill/ 5 Markedly ill/ 6 severely ill/ 7 Among the most extremely ill patient

    1 is the best score (very much improved) 7 is the worse score (very much worse)

    CGI-S scale explores 3 items : Global impression/ Sleepiness/ Cataplexy

    Measured: 14 days after the end of treatment period I

  11. Clinical Global Impression for Severity (CGI-S) Cataplexy

    CGI-S is a scale completed by the investigator at each visit for Cataplexy

    CGI-S us a scale filled by the Investigator or his/her designee from screening to last visit (all the visits) Investigators have to chose 1 condition among 7 : 1 Normal-Not ill at all/ 2 Borderline ill/ 3 Mildly ill/ 4 Moderately ill/ 5 Markedly ill/ 6 severely ill/ 7 Among the most extremely ill patient

    1 is the best score (very much improved) 7 is the worse score (very much worse)

    CGI-S scale explores 3 items : Global impression/ Sleepiness/ Cataplexy

    Measured: 14 days after the end of treatment period I

  12. EQ-5D European Quality of Life EQ-5D (Visual Analogic Scale Part)

    EQ-5D is a quality of life questionnaire filled in by the participants from screening to the last visit (all visits).

    The EQ-5D is a questionnaire assessing the quality of life of the patient. It has two parts:

    The first part is a descriptive system that assesses five distinct health states/dimensions: Mobility (MO), Self-care (SC), Usual activities (UA), Pain/discomfort, Anxiety/depression (AD). A higher score signifies a higher number of symptoms present.

    The second part is a 100 mm Visual analogic scale (EQ-VAS). An higher score in VAS indicates a better health state.

    The questionnaire is assessed at baseline and all subsequent visits

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionDec 2018
  4. Study completionFeb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02821715
Sponsor's protocol ID
THN102-201
Other IDs
2015-005035-41, 2015
Status last verified
Aug 2020
First submitted
23 Jun 2016
Last updated
4 Sep 2020
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing THN102 300/3 and THN102 300/27 in people with Narcolepsy, run by Theranexus at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Epworth Sleepiness Scale (ESS) (time frame: 14 days after the beginning of treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02821715.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.

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