Safety and efficacy study of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson’s disease.

Phase 1

• Conditions: Excessive daytime sleepiness associated with Parkinson’s disease; MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: PTClassification code 10041349Term: SomnolenceSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-004475-31-HU
• Lead Sponsor: Theranexus S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-09
• Study Completion: 2019-12-20
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

1. Subjects with a diagnosis of idiopathic Parkinson’s disease as defined by the Movement Disorders Society (MDS).
2. Subjects with Hoehn and Yahr scale score = 4.
3. Males or females, aged between 18 and 75 years.
4. Body mass index > 18 kg/m2 and < 30 kg/m2.
5. Subjects should have a complaint of daytime sleepiness impacting their quality of life and/or daytime functioning (e.g. falling asleep while reading or watching TV, while eating or talking with other people).
6. Epworth Sleepiness Scale (ESS) score = 14.
7. Women of childbearing potential (not surgically sterile or < 2 years postmenopausal), must use a medically accepted method of contraception, and must continue for the duration of the trial (and for 2 months after participation in the trial). Acceptable methods of contraception include barrier method with spermicide, steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method, intrauterine device (IUD), or true abstinence, i.e. when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence, such as calendar, ovulation, sympto-thermal, post-ovulation methods, and withdrawal are not acceptable methods of contraception).
8. Subjects willing and able to follow trial procedures (including to swallow IMP capsules) and to regularly attend scheduled clinic visits as specified in the protocol, and who have signed the informed consent prior to any screening procedure.
All above-mentioned inclusion criteria will be checked at VS1.
At VR the following inclusion criteria will be re-checked: 5, 6, 7, 8.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

Exclusion criteria
1. Subjects with known or with a suspected sleep apnea syndrome or who have any other cause of excessive daytime sleepiness.
2. Psychiatric and neurological disorders (other than Parkinson’s disease), such as idiopathic narcolepsy, Alzheimer’s disease, Huntington’s Chorea, multiple sclerosis, epilepsy, psychosis, bipolar disorder, severe clinical anxiety or depression or other problem that in the investigator’s opinion would preclude the subject’s participation and completion of this trial or comprise reliable representation of subjective symptoms.
3. Cardiovascular disorders such as 2nd or 3rd grade atrioventricular block or chronic bifascicular block, unless an adequate pacemaker is present. Sinus node dysfunction, atrial fibrillation and ventricular arrhythmias considered as medically significant (except chronic atrial fibrillation controlled by stable doses of amiodarone, calcium channel blocker or beta-blocker), cardiac insufficiency, documented Brugada syndrome, recent myocardial infarction (less than three months before VS1).
4. Subjects with current impulse control disorder.
5. Subjects showing dementia or with MoCA < 23.
6. Subjects with current suicidal risk, based on investigator’s clinical judgement or with a yes” answer to item 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at VS1.
7. Current or recent (within one year) history of substance abuse or dependence disorder as defined in Diagnostic and Statistical Manual of Mental Disorders (DSM-V), e. g. alcohol. Tobacco use is accepted.
8. Other active clinically significant illness, including unstable cardiovascular, or malignant pathology which could interfere with the trial conduct or counter-indicate the trial treatments or place the subject at risk during the trial or compromise the trial participation.
9. Subjects with severe hepatic or renal impairment, or with any other significant abnormality in the physical examination or clinical laboratory results at VS1.
10. Known hypersensitivity to IMP (active ingredients or excipients of modafinil or flecainide capsules).
11. Subjects currently (or within 6 weeks before VS1) under one of the following medications (isolated intake up to 1 week can be accepted):
a. Neuroleptics, anxiolytics, anticonvulsants. Benzodiazepines and benzodiazepine-like drugs are only authorised if used regularly at stable indicated doses with an evening intake as sleep promoting agents.
b. Flecainide or other class I antiarrhythmic drugs.
c. Psychostimulants (except caffeine if no abuse and stable consumption) such as, but not limited to, modafinil, methylphenidate, amphetamine.
d. Antidepressants except if maintained at stable dose for at least 6 weeks before visit VS1 and anticipated to remain stable during the trial in subjects with mild or moderate unipolar depression.
e. Antiemetic medications (except domperidone), myo-relaxing drugs and opioids.
f. Dopaminergic medications, unless they have been used at stable doses for at least 4 weeks before screening and it is anticipated that the doses will not be changed throughout the trial.
12. Pregnancy or lactation. Women of childbearing potential who intend to be pregnant during the next few months.
13. Subjects protected by the law (legal guardianship).
14. Subjects participating in any other clinical trial within 60 days prior to visit VS1 in this trial or still in the protected period imposed by a previous trial.
15. Subjects working in an occupation requiring var

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified