Safety and efficacy study of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson’s disease.
- Conditions
- Excessive daytime sleepiness associated with Parkinson’s diseaseMedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0 Level: PT Classification code 10041349 Term: Somnolence System Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2017-004475-31-CZ
- Lead Sponsor
- Theranexus S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
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 80 years.
4. Body mass index > 18 kg/m2 and < 35 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 highly effective method of contraception, and must continue for the duration of the trial (and for 2 months after participation in the trial). Highly effective methods of contraception include hormonal contraception associated with inhibition of ovulation (combined estrogen/progestogen: oral, intravaginal, transdermal; progestogen-only: oral, implanted, and injected) in conjunction with a barrier method (preferably male condom)., Highly effective methods further include intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner (provided that the partner is the sole sexual partner of the subject and the vasectomised partner has received medical assessment of the surgical success) and sexual abstinence, i.e. when this is in line with the preferred and usual lifestyle of the subject.
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
1. Subjects with known or with a suspected sleep apnea syndrome or who have any other cause of excessive daytime sleepiness, such as shift work sleep disorder.
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, multiple system atrophy (Shy-Drager syndrome) 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
a.Uncontrolled moderate to severe hypertension
b.ECG QTcF duration = 450 ms (men) or = 470 (women)
c.ECG signs of left ventricular hypertrophy (exclusion if at least one of the three indices is abnormal):
•Sokolow-Lyon voltage (sum of amplitude of the S wave in lead V1 and the R wave in lead V5 or V6 = 3.5 mV), or
•Cornell voltage (S wave in V3 + R wave in aVL > 2.8 mV in men or > 2.0 mV in women), or
•Modified Cornell (R wave in aVL > 1.1 mV)
d.Recent (less than three months before screening visit VS1) myocardial infarction
e.Stable or unstable angina pectoris
f.Cardiac insufficiency
g.Previous history of heart failure
h.Previous history of cardiac valvular surgery
i.Ventricular arrhythmias considered as clinically significant
j.Atrial fibrillation unless it is stable and controlled by stable doses of amiodarone, calcium channel blocker or beta-blocker
k.2nd or 3rd grade atrioventricular block or chronic bifascicular block, unless an adequate pacemaker is present
l.Sinus node dysfunction
m.Documented Brugada syndrome
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 and/or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at VS1, referring to the last month before screening.
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 patholog, significant abnormality in physical examination or clinical laboratory results at VS1, 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 hepatic impairment (serum total bilirubin = 34 mg/dL, except in patients diagnosed with Gilbert’s syndrome, or prothrombin time [PT] = 4 s (except in patients on therapeutic anti-coagulation), or serum albumin < 3.5 g/dL)), or renal impairment (glomerular filtration rate [GFR] < 60 mL/min/1.73 m2, according to Kidney Disease Improving Global Outcomes (KDIGO)).
10. Known hypersensitivity to IMP (active in
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method