Trial · NCT03624920

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

NCT03624920, Phase 2, Completed, Theranexus; results first posted 2020-12-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness. Trials, record NCT03624920. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03624920

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness
NCT number: NCT03624920
Status: Completed
Phases: Phase 2
Enrollment: 77 participants, actual
Lead sponsor: Theranexus
Conditions: Parkinson Disease
Interventions: THN102 Dosage A, THN102 Dosage B, THN102 Dosage C
First posted: 2018-08-10
Last updated: 2020-12-01
Results first posted: 2020-12-01

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Safety Adverse Events	2 weeks	Number of participants with spontaneously reported treatment-related adverse events
Secondary	Epworth Sleeping Scale (ESS)	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.
Secondary	Psychomotor Vigilance Test (PVT) : Reaction Time (Miliseconds) Change From Baseline	2 weeks	PVT measures reaction time in milliseconds. The results below are corresponding to the reaction time change from baseline.
Secondary	Montreal Cognitive Assessment Battery (MoCA)	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.
Secondary	Efficacy in Improving Sleepiness (ESS). Responders Rate, Change From Baseline	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
Secondary	Efficacy in Improving Sleepiness (ESS). Patients in Remission, Change From Baseline	2 weeks	Number of patients in remission (=without residual sleepiness), i.e. ESS \< 11 at the end of each treatment period

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Safety Adverse Events	2 weeks	Overall number of participant reported corresponds to the safety set population of the clinical report	participants	NUMBER
SECONDARY	Epworth Sleeping Scale (ESS)	2 weeks	modified intent to treat	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Psychomotor Vigilance Test (PVT) : Reaction Time (Miliseconds) Change From Baseline	2 weeks	PVT full analysis set	millisecond (msec)	LEAST_SQUARES_MEAN
SECONDARY	Montreal Cognitive Assessment Battery (MoCA)	2 weeks	mITT	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Efficacy in Improving Sleepiness (ESS). Responders Rate, Change From Baseline	2 weeks	mITT	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Efficacy in Improving Sleepiness (ESS). Patients in Remission, Change From Baseline	2 weeks	mITT	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group39

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Safety Adverse Events	Placebo	Subjects with at least one TEAE leading to death	0	participants
Safety Adverse Events	THN102 200/2	Subjects with at least one TEAE leading to death	0	participants
Safety Adverse Events	THN102 200/18	Subjects with at least one TEAE leading to death	0	participants
Safety Adverse Events	Placebo	Subject with at least one serious TEAE	0	participants
Safety Adverse Events	THN102 200/2	Subject with at least one serious TEAE	0	participants
Safety Adverse Events	THN102 200/18	Subject with at least one serious TEAE	1	participants
Safety Adverse Events	Placebo	Subjects with at least one related serious TEAE	0	participants
Safety Adverse Events	THN102 200/2	Subjects with at least one related serious TEAE	0	participants
Safety Adverse Events	THN102 200/18	Subjects with at least one related serious TEAE	0	participants
Safety Adverse Events	Placebo	Subjects with at least one TEAE	19	participants

1 to 10 of 39Source ClinicalTrials.gov

See all 39 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Sequence ABC	14
Overall Study	STARTED	Sequence BCA	14
Overall Study	STARTED	Sequence CAB	13
Overall Study	STARTED	Sequence ACB	13
Overall Study	STARTED	Sequence CBA	11
Overall Study	STARTED	Sequence BAC	12
Overall Study	COMPLETED	Sequence ABC	13
Overall Study	COMPLETED	Sequence BCA	12
Overall Study	COMPLETED	Sequence CAB	12
Overall Study	COMPLETED	Sequence ACB	12

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events33

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	Nervous system disorders	THN102 Placebo	0	68	0
other	Headache	Nervous system disorders	THN102 200/2	2	72	2
other	Headache	Nervous system disorders	THN102 200/18	4	73	4
other	Insomnia	Psychiatric disorders	THN102 Placebo	0	68	0
other	Insomnia	Psychiatric disorders	THN102 200/2	1	72	1
other	Insomnia	Psychiatric disorders	THN102 200/18	2	73	2
other	Confusional state	Psychiatric disorders	THN102 Placebo	0	68	0
other	Confusional state	Psychiatric disorders	THN102 200/2	0	72	0
other	Confusional state	Psychiatric disorders	THN102 200/18	2	73	2
other	Nightmare	Psychiatric disorders	THN102 Placebo	0	68	0

1 to 10 of 33Source ClinicalTrials.gov

See all 33 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	THN102 Placebo	0	68
Total, all-cause mortality	THN102 200/2	0	72
Total, all-cause mortality	THN102 200/18	0	73
Total, other adverse events	THN102 Placebo	3	68
Total, other adverse events	THN102 200/2	10	72
Total, other adverse events	THN102 200/18	22	73
Total, serious adverse events	THN102 Placebo	0	68
Total, serious adverse events	THN102 200/2	0	72
Total, serious adverse events	THN102 200/18	1	73

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Psychomotor Vigilance Task	Secondary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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