Study Evaluating Efficacy and Safety of OSU6162 in the Treatment of Residual Symptoms After Stroke — OSU6162DB003  

Stroke Sequelae Clinical Trial

Official title: Double-blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy and Safety of OSU6162 in the Treatment of Residual Symptoms After Stroke

Status Completed

Clinical Trial 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.

Clinical Trial Description

Main objectives of this study are to evaluate the efficacy and safety of OSU6162 compared to placebo with respect to treatment response in post stroke patients.

Endpoints:

Primary endpoint is Clinical Global Impression of Change (CGI-C) after 16 weeks of treatment.

Secondary endpoints are:

CGI-C score after 4, 8 and 12 weeks of treatment. FAI; MFS; FSS; BDI; SF-36 scores after 4, 8, 12 and 16 weeks of treatment. Correlation between plasma concentration of OSU6162 and therapeutic response after 4 and 16 weeks of treatment.

Safety variables: AE/SAE, physical and neurological examinations, vital signs (blood pressure and puls) and laboratory test.

Study Design:

The treatment period is 16 weeks, during which all patients will make 7 study visits and have 4 telephone interviews.

Study visits include:

Visit 1: screening at week -2, Days -14 to -5 Visit 2: baseline at week 0 Visit 4: week 4 ± 3 days Visit 6: week 8 ± 3 days Visit 8: week 12 ± 3 days Visit 10: week 16 ± 3 days Visit 11: follow up at week 20 ± 7 days

Randomization and start of treatment with OSU6162 or placebo at baseline, visit 2, week 0. Study medication administered during all study visits from baseline at visit 2 to visit 8 at week 12.

Physical and neurological examinations, vital signs and weight recording during all study visits.

ECG recorded during visits 1 (week -2) and 10 (week 16). Blood (and urine) sampling for safety labs during visits 1 (week -2), visit 4 (week 4), visit 10 (week 16). Pregnancy test at visit 1 and 10.

Blood sampling for analysis of plasma OSU6162 concentration at visit 4 and 10.

Primary outcome measures and secondary outcome self-assessment tests performed during all study visits.

Telephone interviews at visit: 3 (week 2 ± 3 days), 5 (week 6 ± 3 days), 7 (week 10 ± 3 days) and 9 (week 14 ± 3 days.

Concomitant medication, adverse events and drug compliance are recorded during all visits and telephone interviews.

Dosing:

All patients in the OSU6162 group start with a dose of 15 mg BID. The dose is increased to a maximum of 30 mg BID after 4 weeks of treatment. Intermediate doses are allowed and the final dose is individually flexible, depending on the therapeutic response and presence of AE. In the placebo group patients receive tablets with identical appearance to active treatment tablets (OSU6162 15 mg), administered according to the same dosing regime as active treatment.

Data analysis and statistics:

Efficacy analyses will be based on Mixed Models for Repeated Measures (MMRM) analyses. The MMRM analyses use all the longitudinal observations at each post-baseline visit for the study period of interest. Significance tests will be based on estimated population marginal means and Type III test of fixed effects, using a two-sided test with the significance level of 0.05. Differences in distributions of categorical variables will be tested using the Chi-square test or Fisher's exact test.

Due to the large number of variables engendered, multivariate statistical evaluations will be performed as a complement to the above-mentioned statistical methods.

Before unblinding of the study data, a separate Statistical Analysis Plan (SAP) will be prepared.

Patient and data safety:

This study is conducted in accordance with the study protocol, the Declaration of Helsinki, ICH E6 GCP, the European Clinical Trials Directive 2001/20/EC and applicable local laws and regulations.

The Investigator is responsible for ensuring the accuracy, completeness, legibility and timeliness of the data recorded in the CRFs. Data recorded in the CRF that are derived from source documents should be consistent with the source documents or the discrepancies should be explained. Signed sections of CRFs are monitored and collected on a regular basis.

An individual secrecy agreement is established for all Sponsor, site personnel, independent auditors, and representatives from Competent Authorities that will have access to the information in the medical records for the participating patients. ;

Related Conditions & MeSH terms

• Stroke
• Stroke Sequelae

• NCT number: NCT04127669
• Study type: Interventional
• Source: A Carlsson Research AB
• Status: Completed
• Phase: Phase 2
• Start date: March 20, 2017
• Completion date: September 30, 2020