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Study Evaluating Efficacy and Safety of OSU6162 in the Treatment of Residual Symptoms After Stroke

NCT04127669 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2020-10-01

No results posted yet for this study

Summary

Following stroke, a recovery process is promptly initiated, which leads to a partial rehabilitation. However, a number of disabling residual symptoms may persist for years and include mental fatigue, depression, cognitive deficits, neurological problems and more. In the lack of an effective treatment these symptoms will lead to major consequences for the individual and the surrounding society. OSU6162 has in earlier clinical studies of stroke patients shown evidence of a favorable effect on residual symptoms, especially mental fatigue, together with a mild side effect profile.

In this phase II, randomized, placebo-controlled, two-armed study, a 16 week OSU6162 treatment will be compared to an equally long placebo treatment in patients with residual symptoms following stroke.

Conditions

  • Stroke Sequelae

Interventions

DRUG

OSU 6162

The active ingredient of OSU6162 is the S-enantiomer with the chemical name (S)-3-\[3-(methylsulfonyl)phenyl\]-1-propylpiperidine hydrochloride. The substance is a white powder with a melting point of 177-182°C. Solubility in water is \> 2000 mg/ml. Current laboratory code used is OSU6162-HCl. In trial protocol, OSU6162-HCl is shortened to OSU6162.

DRUG

Placebo oral tablet

Circular coated tablet (with identical appearance to active treatment tablets 15 mg).

Sponsors & Collaborators

  • Gottfries Clinic AB

    collaborator UNKNOWN

  • Arvid Carlsson Research AB

    lead INDUSTRY

Principal Investigators

  • Carl-Gerhard Gottfries, Prof. · Gottfries Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-03-20
Primary Completion
2020-01-28
Completion
2020-09-30

Countries

  • Sweden

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 NCT04127669 on ClinicalTrials.gov