Stroke SequelaePhase 2OSU6162DB003NCT04127669
Study Evaluating Efficacy and Safety of OSU6162 in the Treatment of Residual Symptoms After Stroke
A Phase 2 study testing OSU 6162 in people with Stroke Sequelae, run by Arvid Carlsson Research AB at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke Sequelae
- What is being tested?
- OSU 6162
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteSweden
- Study dates
- 20 Mar 2017to 30 Sep 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- Between 18-80 years
- Stroke >12 months prior to the start of the study. Patients must have had the location of their stroke evaluated through a CT scan, noted in their hospital notes
- Anamnestic evidence of post stroke residual symptoms at least 3 months prior to the start of the study
- At least 10.5 points on Mental Fatigue scale at the screening visit 1 (week -2)
Who cannot join
- Residual symptoms following other pathologies than stroke
- Active substance abuse (drug screen taken at visit1)
- Other serious somatic or psychiatric disease
- Beck Depression Inventory >30 at visit1 and 2
- Current pregnancy or breast-feeding, or intention to become pregnant within 3 months after the last dose
- Female patients of childbearing potential not using adequate contraceptives. Female patients of childbearing potential must, for inclusion, use a highly efficient method of contraception, i.e. a method with a failure rate of less than 1% (e.g. sterilisation, hormone implants, hormone injections, some intrauterine devices, or vasectomy in partner). Male patients must agree to use condoms during the study and for 2 weeks after the end of the study/last dose of IMP, unless their partner is using a highly efficient method of contraception, as described above.
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- Pathologic ECG, as assessed by the investigator. Max QTc time on ECG: 450 ms in men and 460 ms in women
- Abnormal laboratory values of such severity that participation in the study, in the opinion of the investigator, is questionable
- Patients who are so debilitated by their disease that they are not assumed to be able to perform the assessments or handle the instruments used for evaluation of effect
- Current participation in other Clinical trials
- Previous treatment with OSU6162
- Clinically significant liver disease which may prevent the patient from completing the study and/or an elevation in either total bilirubin, alkaline phosphatase, AST, ALT of >2 times the laboratory reference
- Clinically significant renal disease which may prevent the patient from completing the study and/or an elevation in serum creatinine of >1.5 times the laboratory reference.
- Any surgical or medical condition which, in the opinion of the investigator, might interfere with the absorption, distribution, metabolism or excretion of OSU6162
- Patients treated with Modiodal, Xyrem, Mirtazapine, Mianserin or metabolic enzyme inhibitors (with the exception of antidepressants other than Mirtazapine and Mianserin) or inducers, or drugs with a narrow treatment window (e.g. warfarin, antiepileptics, cyclosporine) and individually modelled drugs such as lithium.
- Use of drugs capable of inducing hepatic enzyme metabolism (e.g., barbiturates, rifampicin, carbamazepine, phenytoin, primidone) within 30 days prior to the start of the study (or 5 half-lives of the inducing agent, whichever is longer)
- Antipsychotic treatment
- Patients treated with "unstable therapies", i.e., treatments that have not been at the same dose for at least 6 weeks prior to inclusion in this study. The treatment must also remain unchanged during the study period. Insomnia medication and other PRN medications are allowed
- Use of acute or chronic medications for other medical conditions are allowed based on the investigator's judgement. Occasional use of over-the-counter (OTC) medication is allowed at the investigator's discretion
- Supplements from health food stores and naturopathic preparations (dietary supplements, natural remedies) are not allowed during the course of the study or 4 weeks before study start.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy and Safety of OSU6162 in the Treatment of Residual Symptoms After Stroke
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.
Read the detailed 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.
- Conditions
- Stroke Sequelae
- Being tested
- OSU 6162, Placebo oral tablet
- Keywords
- residual symptoms, mental fatigue, dopamine stabilizer
- Medical subject headings
- Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSU 6162Drug
Also called OSU6162-HCl, PNU-9639 1A
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.
Placebo oral tabletDrug
Circular coated tablet (with identical appearance to active treatment tablets 15 mg).
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Active substance treatment with OSU6162. Starting dose for all patients in the OSU6162 treatment group is 15 mg BID. The dose is taken orally as one circular coated tablet of 15 mg together with a light meal in the morning and one tablet around lunch unless otherwise agreed upon. In order to aim at optimal dosing of OSU6162, some flexibility is allowed. The investigators are able to modify the dose for individual patients based on how well the treatment is tolerated and how well the patients respond to it. In the case where there is no clear response, the dose can be increased to maximally 30 mg BID (intermediate dosage is allowed) after 4 weeks of treatment; it is also possible to decrease the dose to a lower level (even below 15 mg BID) if a higher dose is not tolerated and/or there is a perceived weakened therapeutic effect with the higher dose. All dose changes will be performed while retaining the blind. Receives: Drug: OSU 6162 |
| Arm B | Placebo comparator | Placebo treatment. Starting dose for all patients in the placebo group is one circular coated tablet (with identical appearance to active treatment tablets 15 mg) taken BID, according to the same schedule as active treatment. The dose may be increased or decreased in the same manner as for active treatment. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression of Change (CGI-C)
The CGI-C is a 7-point scale that requires the clinician to assess how much the patient´s illness has improved or worsened relative to a baseline state at the beginning of the study. CGI-C is rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Rating is performed by interviewing the patient to assess function and mental status.
Measured: Assessment at week 16
Secondary outcomes (6)
Clinical Global Impression of Change (CGI-C)
Measured: Assessment at week 4, 8, and 12.
Change in Frenchay Activity Index (FAI)
Change in FAI score is studied by comparing baseline value with values at several assessment points throughout the study.
FAI is a measure of instrumental activities of daily living for use with patients recovering from stroke. The FAI assesses a broad range of activities associated with everyday life. The index consists of 15 questions.
Measured: Assessment at baseline and at week 4, 8, 12, and 16.
Change in Mental Fatigue Scale (MFS)
Change in MFS score is studied by comparing baseline value with values at several assessment points throughout the study.
The MFS is a self-assessment questionnaire to investigate the therapeutic effects of OSU6162 with focus on the mental fatigue and concentration capacity.
The scale consists of 15 items of which 13 measure mental symptoms. Either reduced or increased sleep is measured. Variations around the clock are also rated.
Measured: Assessment at baseline and at week 4, 8, 12, and 16.
Change in Fatigue Severity Scale (FSS)
Change in FSS score is studied by comparing baseline value with values at several assessment points throughout the study.
The FSS is a 9-item self-report scale that measures the severity of fatigue and its effect on a person's activities. The items are scored on a 7-point scale with 1 = strongly disagree and 7= strongly agree, higher scores reflecting more fatigue.
Measured: Assessment at baseline and at week 4, 8, 12, and 16.
Change in Becks Depression Inventory (BDI)
Change in BDI score is studied by comparing baseline value with values at several assessment points throughout the study.
BDI is a widely used self-report instrument for assessing the degree of depression and changes in depression level. The inventory consists of 21 items about different symptoms and attitudes which are to be valued on a four point scale ranging from 0-3. A total score is calculated by summarizing the scores of the 21 items. Higher total scores indicate more severe depressive symptoms.
Measured: Assessment at baseline and at week 4, 8, 12, and 16.
Change in SF-36 Health Survey
Change in SF-36 score and subscores are studied by comparing baseline values with values at several assessment points throughout the study.
The SF-36 Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in each section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability, the higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
The eight sections are:
- vitality
- physical functioning
- bodily pain
- general health perceptions
- physical role functioning
- emotional role functioning
- social role functioning
- mental health
Measured: Assessment at baseline and at week 4, 8, 12, and 16.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start20 Mar 2017
- Primary completion28 Jan 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke SequelaeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomised, placebo-controlled, parallel-group (two-armed) study of 16 weeks' treatment duration, comparing OSU6162 with placebo treatment in patients with residual symptoms after stroke.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arvid Carlsson Research AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gottfries Clinic AB
- Responsible party
- Sponsor
- Investigators
- Carl-Gerhard Gottfries, Prof., Principal investigator, Gottfries Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127669
- Sponsor's protocol ID
- OSU6162DB003
- Other IDs
- 2016-003888-19, 2016
- Acronym
- OSU6162DB003
- Status last verified
- Sep 2020
- First submitted
- 9 Oct 2019
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy and Safety of OSU6162 in the Treatment of Residual Symptoms After Stroke
- ClinicalTrials.gov ID
- NCT04127669
- Acronym / sponsor ID
- OSU6162DB003 / OSU6162DB003
- Conditions
- Stroke Sequelae
- Keywords
- residual symptoms, mental fatigue, dopamine stabilizer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Arvid Carlsson Research ABIndustry (pharma, biotech, devices)
- Collaborators
- Gottfries Clinic AB
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 28 Jan 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a randomised, placebo-controlled, parallel-group (two-armed) study of 16 weeks' treatment duration, comparing OSU6162 with placebo treatment in patients with residual symptoms after stroke.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: OSU 6162Active substance treatment with OSU6162. Starting dose for all patients in the OSU6162 treatment group is 15 mg BID. The dose is taken orally as one circular coated tablet of 15 mg together with a light meal in the morning and one tablet around lunch unless otherwise agreed upon. In order to aim at optimal dosing of OSU6162, some flexibility is allowed. The investigators are able to modify the dose for individual patients based on how well the treatment is tolerated and how well the patients respond to it. In the case where there is no clear response, the dose can be increased to maximally 30 mg BID (intermediate dosage is allowed) after 4 weeks of treatment; it is also possible to decrease the dose to a lower level (even below 15 mg BID) if a higher dose is not tolerated and/or there is a perceived weakened therapeutic effect with the higher dose. All dose changes will be performed while retaining the blind. |
| Arm B | Placebo comparator | Drug: Placebo oral tabletPlacebo treatment. Starting dose for all patients in the placebo group is one circular coated tablet (with identical appearance to active treatment tablets 15 mg) taken BID, according to the same schedule as active treatment. The dose may be increased or decreased in the same manner as for active treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed written informed consent
- Between 18-80 years
- Stroke >12 months prior to the start of the study. Patients must have had the location of their stroke evaluated through a CT scan, noted in their hospital notes
- Anamnestic evidence of post stroke residual symptoms at least 3 months prior to the start of the study
- At least 10.5 points on Mental Fatigue scale at the screening visit 1 (week -2)
Key exclusion criteria (20 listed)
- Residual symptoms following other pathologies than stroke
- Active substance abuse (drug screen taken at visit1)
- Other serious somatic or psychiatric disease
- Beck Depression Inventory >30 at visit1 and 2
- Current pregnancy or breast-feeding, or intention to become pregnant within 3 months after the last dose
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OSU 6162Also: OSU6162-HCl, PNU-9639 1AThe 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 | Arm A |
| Placebo oral tabletCircular coated tablet (with identical appearance to active treatment tablets 15 mg). | Drug | Arm B |
Primary outcome
Clinical Global Impression of Change (CGI-C)
Time frame: Assessment at week 16
The CGI-C is a 7-point scale that requires the clinician to assess how much the patient´s illness has improved or worsened relative to a baseline state at the beginning of the study. CGI-C is rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Rating is performed by interviewing the patient to assess function and mental status.
6 secondary outcomes
Clinical Global Impression of Change (CGI-C)
Time frame: Assessment at week 4, 8, and 12.
Change in Frenchay Activity Index (FAI)
Time frame: Assessment at baseline and at week 4, 8, 12, and 16.
Change in Mental Fatigue Scale (MFS)
Time frame: Assessment at baseline and at week 4, 8, 12, and 16.
Change in Fatigue Severity Scale (FSS)
Time frame: Assessment at baseline and at week 4, 8, 12, and 16.
Change in Becks Depression Inventory (BDI)
Time frame: Assessment at baseline and at week 4, 8, 12, and 16.
Change in SF-36 Health Survey
Time frame: Assessment at baseline and at week 4, 8, 12, and 16.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- EU Clinical Trials RegisterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl-Gerhard Gottfries, Prof. principal investigator
Gottfries Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OSU 6162 in people with Stroke Sequelae, run by Arvid Carlsson Research AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impression of Change (CGI-C) (time frame: Assessment at week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.