Traumatic Brain InjuryPhase 4MLC901NCT04487275
MLC901 for Moderate to Severe Traumatic Brain Injury (Specified Drug Code)
A Phase 4 study of Traumatic Brain Injury, run by Ali Amini Harandi at 1 site in Iran.
Trial summary
Patients with a diagnosis of moderate to severe traumatic brain injury (TBI) will be enrolled. Subjects will be randomly assigned to receive either MLC901 (Specified Drug Code) or placebo capsules three times per day over 6 months. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIran
- Study dates
- 20 Aug 2018to Oct 2020
- Phase
- Phase 4
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age between 15 and 65
- non-penetrating moderate (Glasgow Coma Scale score [GCS] 9-12) or severe (GCS 3-8) traumatic brain
- injury less than 24 hrs from traumatic injury
- anticipated intensive care unit length of stay at least 48 hrs
Who cannot join
- GCS = 3 and fixed dilated pupils or penetrating injury
- coexisting injury or medical conditions which could adversely affect our study outcome measures
- dependence for everyday activities before the injury
- pregnancy or breastfeeding
- known allergy to any of MLC901 components
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Brain Mapping Research Center
Tehran
Ali Amini Harandi, MD, +989126026214, amini_alli@yahoo.com
About this study
Official title: MLC901 for Moderate to Severe Traumatic Brain Injury: Pilot, Randomized, Double-Masked, Placebo-controlled Trial
Patients with a diagnosis of moderate to severe traumatic brain injury (TBI) will be enrolled. Subjects will be randomly assigned to receive either MLC901 (Specified Drug Code) or placebo capsules three times per day over 6 months. Evaluation of patients will be carried out at baseline as well as at 3-month and 6-month follow-up visits. Modified Rankin Scale (mRS) and Glasgow outcome scale (GOS) will be used to examine patients. Efficacy will be evaluated by comparing these two scores between the 2 groups at follow-up visits.
- Conditions
- Traumatic Brain Injury
- Being tested
- MLC901 or Placebo
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLC901 or PlaceboDrug
Also called Placebo
groups randomly assigned to receive either MLC901 or placebo capsules three times per day over 6 months
| Study group | Role | What they receive |
|---|---|---|
| Drug | Experimental | MLC901 capsules three times per day over 6 months Receives: Drug: MLC901 or Placebo |
| Placebo | Placebo comparator | Placebo capsules three times per day over 6 months Receives: Drug: MLC901 or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional outcome 1
functional outcome scales of GOS
Measured: at baseline
functional outcome 2
functional outcome scales of GOS
Measured: at 3rd month post-injury
functional outcome 3
functional outcome scales of GOS
Measured: at 6th month post-injury
functional outcome 4
functional outcome scales of MRS
Measured: at baseline
functional outcome 5
functional outcome scales of MRS
Measured: at 3rd month post-injury
functional outcome 6
functional outcome scales of MRS
Measured: at 6th month post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start20 Aug 2018
- Primary completionSep 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ali Amini Harandi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ali Amini Harandi, Shahid Beheshti University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487275
- Sponsor's protocol ID
- 23-299
- Acronym
- MLC901
- Status last verified
- Jul 2020
- First submitted
- 17 Jul 2020
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MLC901 for Moderate to Severe Traumatic Brain Injury: Pilot, Randomized, Double-Masked, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04487275
- Acronym / sponsor ID
- MLC901 / 23-299
- Conditions
- Traumatic Brain Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ali Amini HarandiUniversity, hospital or other
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 27 Jul 2020 (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.
Patients with a diagnosis of moderate to severe traumatic brain injury (TBI) will be enrolled. Subjects will be randomly assigned to receive either MLC901 (Specified Drug Code) or placebo capsules three times per day over 6 months. Evaluation of patients will be carried out at baseline as well as at 3-month and 6-month follow-up visits. Modified Rankin Scale (mRS) and Glasgow outcome scale (GOS) will be used to examine patients. Efficacy will be evaluated by comparing these two scores between the 2 groups at follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug | Experimental | Drug: MLC901 or PlaceboMLC901 capsules three times per day over 6 months |
| Placebo | Placebo comparator | Drug: MLC901 or PlaceboPlacebo capsules three times per day over 6 months |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- age between 15 and 65
- non-penetrating moderate (Glasgow Coma Scale score [GCS] 9-12) or severe (GCS 3-8) traumatic brain
- injury less than 24 hrs from traumatic injury
- anticipated intensive care unit length of stay at least 48 hrs
Key exclusion criteria (5 listed)
- GCS = 3 and fixed dilated pupils or penetrating injury
- coexisting injury or medical conditions which could adversely affect our study outcome measures
- dependence for everyday activities before the injury
- pregnancy or breastfeeding
- known allergy to any of MLC901 components
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 |
|---|---|---|
| MLC901 or PlaceboAlso: Placebogroups randomly assigned to receive either MLC901 or placebo capsules three times per day over 6 months | Drug | Drug, Placebo |
Primary outcome
functional outcome 1
Time frame: at baseline
functional outcome scales of GOS
functional outcome 2
Time frame: at 3rd month post-injury
functional outcome scales of GOS
functional outcome 3
Time frame: at 6th month post-injury
functional outcome scales of GOS
functional outcome 4
Time frame: at baseline
functional outcome scales of MRS
functional outcome 5
Time frame: at 3rd month post-injury
functional outcome scales of MRS
functional outcome 6
Time frame: at 6th month post-injury
functional outcome scales of MRS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Traumatic Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Traumatic Brain Injury, run by Ali Amini Harandi at 1 site in Iran.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Jul 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 Iran. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Amini Harandi, MD (+989126026214, amini_alli@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional outcome 1 (time frame: at baseline). The study lists 6 primary outcomes in all. 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 27 Jul 2020.