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Ischemic StrokePhase 2RESTORENCT02530307

HT-3951 vs. Placebo in Stroke Rehabilitation

A Phase 2 study testing HT-3951 in people with Ischemic Stroke, run by Dart NeuroScience, LLC at 18 sites in United States.

Terminated

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

Official record
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Trial summary

This is a randomized, double-blind, placebo-controlled parallel group outpatient study that will utilize standard stroke rehabilitation outcome measures, as well as fMRI techniques in a subset of subjects, to evaluate the effect of HT-3951 on motor recovery and behavior in medically stable subjects following ischemic… Read more about this study

Who is it for?
Ages 21 to 85 years
Conditions the study is for
Ischemic Stroke
What is being tested?
HT-3951
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
61 participants
Where
18 sitesUnited States
Study dates
Feb 2016to 31 Dec 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 21 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Main Inclusion Criteria:

  • Age range between 21 to 85 years, inclusive, at the Screening Visit
  • Subjects who have experienced an ischemic stroke documented by CT or MRI resulting in an upper extremity deficit that, in the opinion of the Investigator, warrants the need for rehabilitation therapy
  • Medically stable subjects who are able to be randomized to study medication beginning between ≥ 2 and ≤ 52 weeks post-stroke
  • Subjects who have initiated, are undergoing, have completed or agree to begin physical or occupational rehabilitation for at least 2 weeks prior to study Day 1.
  • Mild to moderate unilateral upper extremity motor impairment characterized by FMA-EU score of > 18
  • Modified Rankin Scale score of 1 to 4

Main Exclusion Criteria:

  • History of stroke within 6 months prior to the subject's current episode of ischemic stroke (History of transient ischemic attacks or ischemic stroke (nonhemorrhagic) more than 6 months prior to the current ischemic stroke are acceptable.)
  • Subjects with unresolved upper or lower motor deficits (e.g., range of motion or strength deficits) from any prior stroke
  • Significant hemorrhagic stroke
  • Any history of seizure disorder or a spontaneous seizure that had occurred at any time after the stroke
  • Apraxia that, in the Investigator's opinion, would likely reduce the ability of the subject to participate in the study or confound study outcome measures
  • Moderate to severe aphasia and/or severe language deficits
  • Severe sensory loss in affected hand
  • Moderate to severe hemispatial neglect or anosognosia involving the affected arm
  • Absent proprioception at the elbow or shoulder joints
  • Excessive spasticity in the affected elbow, defined as a score of greater than or equal to 3 on the Modified Ashworth Spasticity scale (MAS)

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Dallas, Texas

  • Study site

    Downey, California

  • Study site

    Elkins Park, Pennsylvania

  • Study site

    Glendale, California

  • Study site

    Grand Rapids, Michigan

  • Study site

    Houston, Texas

  • Study site

    Kansas City, Missouri

  • Study site

    Loma Linda, California

  • Study site

    New York, New York

  • Study site

    Orlando, Florida

  • Study site

    Phoenix, Arizona

  • Study site

    Portland, Oregon

  • Study site

    Scottsdale, Arizona

  • Study site

    Tulsa, Oklahoma

  • Study site

    West Orange, New Jersey

  • Study site

    White Plains, New York

Other trials in United States

About this study

Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled 21-Day Treatment Study, Including an fMRI Sub-Study, to Evaluate the Effect of HT-3951 on Upper Extremity Motor Function Following Ischemic Stroke

This is a randomized, double-blind, placebo-controlled parallel group outpatient study that will utilize standard stroke rehabilitation outcome measures, as well as fMRI techniques in a subset of subjects, to evaluate the effect of HT-3951 on motor recovery and behavior in medically stable subjects following ischemic stroke.

Conditions
Ischemic Stroke
Being tested
HT-3951, Placebo
Keywords
Stroke,, Rehabilitation, Ischemic, fMRI
Medical subject headings
Ischemic Stroke, Stroke, Ischemia

What participants receive

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

  • HT-3951Drug

  • PlaceboDrug

Study groups in NCT02530307
Study groupRoleWhat they receive
HT-3951 (15mg)ExperimentalHT-3951 capsules administered once daily
Receives: Drug: HT-3951
PlaceboPlacebo comparatorPlacebo capsules administered once daily
Receives: Drug: Placebo

What is being measured

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

  1. Fugl-Meyer Assessment of Upper Extremity, Part A-D

    Measured: 21-days

  2. Index Finger-Tapping Frequency Test

    Measured: 21-days

  3. Nine-Hole Peg Test

    Measured: 21-days

  4. Hand Grip Strength Dynamometer Test

    Measured: 21-days

  5. Arm Motor Ability Test-9

    Measured: 21-days

  6. Stroke Impact Scale (hand domain)

    Measured: 21-days

  7. Somatosensory evoked potential (if available)

    Measured: 21-days

Secondary outcomes (2)

  1. Two-Minute Walk Test

    Measured: 21-days

  2. Behavioral, neural activity and motor network connectivity levels, using functional MRI

    Measured: 21-days

Timeline

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

  1. First posted21 Aug 2015 (estimated)
  2. Study startFeb 2016
  3. Primary completion31 Dec 2017
  4. Study completion31 Dec 2017

Why it stopped: Administrative

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02530307
Sponsor's protocol ID
HT-3951-201
Acronym
RESTORE
Status last verified
Jan 2018
First submitted
6 Aug 2015
Last updated
1 Feb 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HT-3951 in people with Ischemic Stroke, run by Dart NeuroScience, LLC at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. 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: Administrative). 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?

Fugl-Meyer Assessment of Upper Extremity, Part A-D (time frame: 21-days). The study lists 7 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 NCT02530307.

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 Feb 2018.

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