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StrokePhase 2NCT02928393

A Study to Evaluate the Safety and Efficacy of Basmisanil in Adults With Severe Motor Impairment Following an Ischemic Stroke

A Phase 2 study testing Basmisanil in people with Stroke, run by Hoffmann-La Roche at 13 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This Phase IIa, randomized, double-blind, placebo-controlled, parallel group study will evaluate the safety, efficacy and pharmacodynamics of basmisanil in adult participants with severe motor impairment following an ischemic stroke. Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Stroke
What is being tested?
Basmisanil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
5 participants
Where
13 sitesin 2 countries
Study dates
20 Feb 2017to 3 Nov 2017
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 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Radiologic assessment confirming an acute middle cerebral artery ischemic stroke
  • Index stroke occurred within the past 3-4 days
  • Inpatient males and females
  • Severe hemiparesis or hemiplegia defined by FMMS score less than or equal to (</=) 35
  • Sufficient speech, vision and hearing to participate in study evaluations

Who cannot join

  • NIHSS greater than (>) 20
  • Severe aphasia that prevents a participant from following directions in rehabilitation
  • Significant deficit from prior strokes or pre-existing motor deficit
  • History of epilepsy, neurosurgery, severe head trauma or central nervous system infections that have residual symptomatology or have required treatment in the last 12 months
  • Known or suspected clinical seizure post-index stroke
  • History of pre-existing dementia or use of medications for dementia
Show all 11Show fewer
  • History of clinically significant pre-existing psychiatric conditions within 12 months prior to stroke
  • Due to undergo carotid surgery within the next 4 months
  • Enrollment/participation in any interventional study (clinical trial) involving an investigational drug (unapproved) or non-drug treatment within the prior 3 months or 6 times the half-life (whichever is longer)
  • Clinically relevant medical conditions that would likely interfere with the study conduct and scheduled assessments
  • Contraindication to magnetic resonance imaging (MRI) or conditions which render interpretation of MRI difficult

Trial locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

Spain7 sites

  • Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia

    Barcelona, 08025

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • La Paz University Hospital

    Madrid

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Virgen del Rocio

    Seville, 41013

  • Hospital Clnico Universitario de Zaragoza

    Zaragoza, 50009

Other trials in Spain

France6 sites

  • CHU de Besancon Hopital Jean Minjoz; Service de Neurologie

    Besançon, 25030

  • Hôpital Pellegrin Tripode - CHU de Bordeaux

    Bordeaux, 33076

  • Hopital la Cavale Blanche

    Brest, 29609

  • Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B

    Clermont-Ferrand, 63003

  • Hôpital General - Service de neurologie; Service de neurologie

    Dijon, 21079

  • Hopital Purpan

    Toulouse, 31059

Other trials in France

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Safety, Efficacy and Pharmacodynamic Study of Basmisanil (RO5186582) in Adults With Severe Motor Impairment Following an Ischemic Stroke

This Phase IIa, randomized, double-blind, placebo-controlled, parallel group study will evaluate the safety, efficacy and pharmacodynamics of basmisanil in adult participants with severe motor impairment following an ischemic stroke.

Conditions
Stroke
Being tested
Basmisanil, Placebo
Keywords
Stroke, Motor impairment, Stroke recovery, Middle cerebral artery stroke, Fugl Meyer, Fugl-Meyer Motor Scale (FMMS)
Medical subject headings
Stroke, Infarction, Middle Cerebral Artery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BasmisanilDrug

    Also called RO5186582

    Basmisanil immediate-release granules at a dose of 240 mg will be given orally twice daily for 90 days.

  • PlaceboDrug

    Placebo matched to basmisanil immediate-release granules will be given orally twice daily for 90 days.

Study groups in NCT02928393
Study groupRoleWhat they receive
BasmisanilExperimentalBasmisanil at a dose of 240 milligrams (mg) orally twice daily for 90 days.
Receives: Drug: Basmisanil
PlaceboPlacebo comparatorPlacebo matched to basmisanil orally twice daily for 90 days.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in FMMS Score at Day 90

    Measured: Baseline (Day 1), Day 90

  2. Number of Participants with Adverse Events

    Measured: Baseline (Day 1) up to 28 days after last dose of study drug (latest at Day 118)

  3. Change From Baseline in Montreal Cognitive Assessment (MoCA) Score at Day 30

    Measured: Baseline (Day 1), Day 30

  4. Change From Baseline in MoCA Score at Day 90

    Measured: Baseline (Day 1), Day 90

  5. Change From Baseline in National Institute of Health Stroke Scale (NIHSS) Score At Day 3

    Measured: Baseline (Day 1), Day 3

  6. Change From Baseline in NIHSS Score At Day 10

    Measured: Baseline (Day 1), Day 10

  7. Change From Baseline in NIHSS Score At Day 30

    Measured: Baseline (Day 1), Day 30

  8. Change From Baseline in NIHSS Score At Day 90

    Measured: Baseline (Day 1), Day 90

  9. Change From Baseline in NIHSS Score At 28 Days After Last Dose

    Measured: Baseline (Day 1) and at 28 days after last dose of study drug (latest on Day 118)

  10. Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Score At Day 3

    Measured: Baseline (Day 1), Day 3

  11. Change From Baseline in C-SSRS Score At Day 30

    Measured: Baseline (Day 1), Day 30

  12. Change From Baseline in C-SSRS Score At Day 60

    Measured: Baseline (Day 1), Day 60

  13. Change From Baseline in C-SSRS Score At Day 90

    Measured: Baseline (Day 1), Day 90

  14. Change From Baseline in C-SSRS Score At 28 Days After Last Dose

    Measured: Baseline (Day 1), at 28 days after last dose of study drug (latest on Day 118)

Secondary outcomes (8)

  1. Change From Baseline in Modified Rankin Scale (mRS) Score At Day 90

    Measured: Baseline (Day 1), Day 90

  2. mRS Score At Day 90

    Measured: Day 90

  3. Change From Baseline in Fugl-Meyer Assessment (FMA) Total Score at Day 90

    Measured: Baseline (Day 1), Day 90

  4. Change From Baseline in FMA Subscale Score at Day 90

    Measured: Baseline (Day 1), Day 90

  5. Apparent Oral Clearance (CL/F) of Basmisanil

    Measured: Predose (Hour 0) (prior to morning dose) on Days 3, 10, 30, 90; 4 and 8 hours post-morning dose on Day 1; and 4 hours post-morning dose on Day 3

  6. Maximum Observed Plasma Concentration (Cmax) of Basmisanil

    Measured: Predose (Hour 0) (prior to morning dose) on Days 3, 10, 30, 90; 4 and 8 hours post-morning dose on Day 1; and 4 hours post-morning dose on Day 3

  7. Apparent Volume of Distribution at Steady States (Vss) of Basmisanil

    Measured: Predose (Hour 0) (prior to morning dose) on Days 3, 10, 30, 90; 4 and 8 hours post-morning dose on Day 1; and 4 hours post-morning dose on Day 3

  8. Area Under the Curve [AUC] of Basmisanil

    Measured: Predose (Hour 0) (prior to morning dose) on Days 3, 10, 30, 90; 4 and 8 hours post-morning dose on Day 1; and 4 hours post-morning dose on Day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2016 (estimated)
  2. Study start20 Feb 2017
  3. Primary completion3 Nov 2017
  4. Study completion3 Nov 2017

Why it stopped: Low participant enrolment

Resources

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
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02928393
Sponsor's protocol ID
BP29937
Other IDs
2015-003227-66, 2015
Status last verified
Dec 2018
First submitted
7 Oct 2016
Last updated
2 Jan 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Basmisanil in people with Stroke, run by Hoffmann-La Roche at 13 sites in 2 countries.

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 11 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: stopped early, as of the sponsor's last update on 2 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Spain, France. 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 was stopped early (reason given: Low participant enrolment). Results are not available in the source record.

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?

Change From Baseline in FMMS Score at Day 90 (time frame: Baseline (Day 1), Day 90). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02928393.

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 2 Jan 2019.

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