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

NCT03624920 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2020-12-01

Study results available
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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.

Conditions

  • Parkinson Disease

Interventions

DRUG

THN102 Dosage A

THN102 Dosages A: placebo

DRUG

THN102 Dosage B

THN102 Dosage B : 200mg/2mg

DRUG

THN102 Dosage C

THN102 Dosage C: 200mg/18mg

Sponsors & Collaborators

  • Theranexus

    lead INDUSTRY

Principal Investigators

  • Jean-Christophe Corvol, Prof · Hôpital La Pitié-Salpêtrière, 75651 Paris, France, Tel. +33 1 42 16 57 66, mail: [email protected]

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-12
Primary Completion
2019-12-20
Completion
2020-02-24
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • France
  • Germany
  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03624920 on ClinicalTrials.gov