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Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03624920
Recruitment Status : Completed
First Posted : August 10, 2018
Results First Posted : December 1, 2020
Last Update Posted : December 1, 2020
Sponsor:
Information provided by (Responsible Party):
Theranexus

Brief Summary:
This is a randomized, placebo-controlled, 3-way cross-over phase IIa trial comparing two dose levels of THN102 to placebo in patients suffering from Parkinson's disease associated with excessive daytime sleepiness.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: THN102 Dosage A Drug: THN102 Dosage B Drug: THN102 Dosage C Phase 2

Detailed Description:
The treatment duration is 2 weeks per period. Each treatment period is followed by a one-week washout period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Complete 3 way-Crossover
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness
Actual Study Start Date : July 12, 2018
Actual Primary Completion Date : December 20, 2019
Actual Study Completion Date : February 24, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: THN102 Dosage A
THN102 Dosage A is a Placebo
Drug: THN102 Dosage A
THN102 Dosages A: placebo
Other Name: Placebo

Experimental: THN102 Dosage B
THN102 Dosage B : 200 mg/2 mg THN102 is a combination of modafinil 100mg and flecainide 1 mg daily dosage is 200 mg of modafinil and 2 mg of flecainide
Drug: THN102 Dosage B
THN102 Dosage B : 200mg/2mg
Other Name: Dosage B

Experimental: THN102 Dosage C
THN102 Dosage C : 200 mg/18 mg THN102 is a combination of modafinil 100mg and flecainide 9 mg daily dosage is 200 mg of modafinil and 18 mg of flecainide
Drug: THN102 Dosage C
THN102 Dosage C: 200mg/18mg
Other Name: Dosage C




Primary Outcome Measures :
  1. Safety Adverse Events [ Time Frame: 2 weeks ]
    Number of participants with spontaneously reported treatment-related adverse events


Secondary Outcome Measures :
  1. Epworth Sleeping Scale (ESS) [ Time Frame: 2 weeks ]
    Range of the scale : 0 to 24. A low score indicates a good outcome. Results shown are corresponding to a change from baseline of the ESS score.

  2. Psychomotor Vigilance Test (PVT) : Reaction Time (Miliseconds) Change From Baseline [ Time Frame: 2 weeks ]
    PVT measures reaction time in milliseconds. The results below are corresponding to the reaction time change from baseline.

  3. Montreal Cognitive Assessment Battery (MoCA) [ Time Frame: 2 weeks ]

    MoCA score reflects the cognitive capacities of a person. Range of the total score of 10 test items: 0 to 30 points. A high score indicates good cognitive functioning. A score of 26 and above is considered normal.

    The results below are shown as change from baseline of the MoCA score.


  4. Efficacy in Improving Sleepiness (ESS). Responders Rate, Change From Baseline [ Time Frame: 2 weeks ]
    ESS score responder rate, defined as the proportion of subjects with at least 25% ESS improvement from baseline, at the end of each treatment period

  5. Efficacy in Improving Sleepiness (ESS). Patients in Remission, Change From Baseline [ Time Frame: 2 weeks ]
    Number of patients in remission (=without residual sleepiness), i.e. ESS < 11 at the end of each treatment period



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with a diagnosis of idiopathic Parkinson's disease as defined by the Movement Disorders Society (MDS).
  • Subjects with Hoehn and Yahr scale score ≤ 4.
  • Body mass index > 18 kg/m2 and < 35 kg/m2.
  • 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 television, while eating or talking with other people).
  • Epworth Sleepiness Scale (ESS) score ≥ 14.

Exclusion Criteria:

  • 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.
  • Psychiatric and neurological disorders (other than Parkinson's disease),
  • Cardiovascular disorders such as - but not limited to
  • Uncontrolled moderate to severe hypertension
  • History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for patients participating in the study
  • Recent myocardial infarction
  • Stable or unstable angina pectoris
  • Cardiac insufficiency or history of heart failure
  • Previous history of cardiac valvular surgery
  • Subjects with current impulse control disorder.
  • Subjects showing dementia or with MoCA < 23.
  • Subjects with current suicidal risk
  • Current or recent (within one year) history of substance abuse or dependence disorder
  • Other active clinically significant illness
  • Subjects with hepatic or renal impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624920


Locations
Show Show 34 study locations
Sponsors and Collaborators
Theranexus
Investigators
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Study Chair: Jean-Christophe Corvol, Prof Hôpital La Pitié-Salpêtrière, 75651 Paris, France, Tel. +33 1 42 16 57 66, mail: jean-christophe.corvol@aphp.fr
  Study Documents (Full-Text)

Documents provided by Theranexus:
Study Protocol  [PDF] February 27, 2019
Statistical Analysis Plan  [PDF] February 21, 2020

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Responsible Party: Theranexus
ClinicalTrials.gov Identifier: NCT03624920    
Other Study ID Numbers: THN102-202
First Posted: August 10, 2018    Key Record Dates
Results First Posted: December 1, 2020
Last Update Posted: December 1, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Sleepiness
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases