ALSPhase 2NIALSNCT05031351
NF-κB Inhibition in Amyotrophic Lateral Sclerosis
A Phase 2 study testing Withania somnifera in people with ALS, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
This is a Phase II, single centre, randomized, parallel, double blind, placebo-controlled clinical trial to determine the safety of Withania somnifera in participants with Amyotrophic Lateral Sclerosis (ALS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ALS
- What is being tested?
- Withania somnifera
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- 19 Oct 2021to Sep 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with laboratory supported probable, clinically possible, probable or definite ALS according to the World Federation of Neurology Revised El Escorial criteria (83) (Appendix A)
- Disease duration from symptom onset no greater than 36 months at the Screening Visit
- Aged 18 years or older
- Capable of providing informed consent and complying with study procedures
- If taking riluzole, on a stable dose for at least 30 days prior to Screening Visit
- If taking edaravone, on a stable dose for at least one cycle prior to Screening Visit
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- If on BiPAP, average usage of no more than 12 hours per day at time of Screening Visit
- Able to swallow a capsule at Baseline Visit
- Fluency in English or French
Who cannot join
- Exposure to any investigational agent or Withania somnifera (Ashwagandha) within 30 days prior to the Screening Visit; simultaneous participation in other observational studies is allowed upon Site Investigator approval
- Presence of any of the following clinical conditions:
- Substance abuse within the past year
- Unstable cardiac, pulmonary, renal, hepatic, endocrine, hematologic, or active malignancy or infectious disease
- Acquired Immunodeficiency Syndrome (AIDS) or AIDS-related complex
- Unstable psychiatric illness defined as psychosis (hallucinations or delusions) or untreated major depression within 90 days prior to the Screening Visit
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- Hypersensitivity or allergy to Withania somnifera
- Uncontrolled diabetes with severe associated complications (such as neuropathy)
- Untreated hypertension, active stomach ulcers, or untreated thyroid disorder
- Previously diagnosed auto-immune condition with or without neurological manifestations (e.g. multiple sclerosis (MS), systemic lupus erythematosus (SLE), rheumatoid arthritis, etc.)
- Current or planned use of oral, intramuscular or intravenous steroid drugs (such as prednisone, prednisolone, dexamethasone, triamcinolone, methylprednisolone, oxandrolone, and others) or immunosuppressant drugs (azathioprine, mycophenolate, tacrolimus, sirolimus, cyclophosphamide, and others) for more than 7 days
- Planned consumption of alcohol, other drugs or natural health products with sedative and anxiolytics properties while taking study drugs (8 week duration)
- Current or planned use of continuous subcutaneous, intravenous or oral anticoagulant drugs
- Scheduled for surgery under general anesthetic within 14 days of Screening Visit
- Pregnancy or planned pregnancy. Women of childbearing potential must have a negative pregnancy test and be non-lactating at the Screening Visit
- Insertion of a diaphragm pacing system
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Lorne Zinman, Lorne.Zinman@sunnybrook.ca
Agessandro Abrahao, agessandro.abrahao@sunnybrook.ca
About this study
Official title: Nuclear Factor Kappa Beta Inhibition in Patients With Amyotrophic Lateral Sclerosis: A Phase II Randomized Placebo Controlled Trial
This is a Phase II, single centre, randomized, parallel, double blind, placebo-controlled clinical trial to determine the safety of Withania somnifera in participants with Amyotrophic Lateral Sclerosis (ALS).
Read the detailed description
There will be up to 75 participants randomized 1:1:1 to receive either high dosage Withania somnifera extract (1088 mg daily), medium dosage Withania somnifera extract (544 mg daily) or matching placebo. The study will consist of a Screening Period, Randomization visit, Baseline visit, and Follow-up visits. The treatment period will be 8 weeks and a final follow up call will occur at Week 9.
- Conditions
- ALS
- Being tested
- Withania somnifera, Placebo
- Keywords
- Withania somnifera, Ashwagandha, Nuclear Factor Kappa Beta Inhibition, Amyotrophic Lateral Sclerosis
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Withania somniferaDrug
Nuclear Factor Kappa Beta Inhibitor
PlaceboDrug
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| High dosage Withania somnifera | Experimental | 544mg oral twice a day Receives: Drug: Withania somnifera |
| Medium dosage Withania somnifera | Experimental | 272mg oral twice a day Receives: Drug: Withania somnifera |
| Placebo | Placebo comparator | Matched capsules twice a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (safety)
Incidence of adverse events
Measured: From Baseline visit until end of study visit (Week 9)
Secondary outcomes (4)
Change in SICI values
Short-interval intracortical inhibition (SICI) measured by transcranial magnetic stimulation (TMS).
Measured: Baseline to 8 weeks
Change in RMT values
Resting motor threshold (RMT) measured by transcranial magnetic stimulation (TMS).
Measured: Baseline to 8 weeks
Change in recovery cycle
This is a lower motor neuron excitability parameter measured by threshold tracking nerve excitability testing (NET).
Measured: Baseline to 8 weeks
Change in strength duration time constant
This is a lower motor neuron excitability parameter measured by threshold tracking nerve excitability testing (NET).
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start19 Oct 2021
- Primary completionJul 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALSStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agessandro Abrahao, MD, MSc, Principal investigator, Sunnybrook Research Institute, University of TorontoLorne Zinman, MD, MSc, Study director, Sunnybrook Research Institute, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031351
- Sponsor's protocol ID
- 032-2017
- Acronym
- NIALS
- Status last verified
- Jun 2022
- First submitted
- 5 Aug 2021
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nuclear Factor Kappa Beta Inhibition in Patients With Amyotrophic Lateral Sclerosis: A Phase II Randomized Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT05031351
- Acronym / sponsor ID
- NIALS / 032-2017
- Conditions
- ALS
- Keywords
- Withania somnifera, Ashwagandha, Nuclear Factor Kappa Beta Inhibition, Amyotrophic Lateral Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 1 Sep 2021 (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.
This is a Phase II, single centre, randomized, parallel, double blind, placebo-controlled clinical trial to determine the safety of Withania somnifera in participants with Amyotrophic Lateral Sclerosis (ALS).
Detailed description
There will be up to 75 participants randomized 1:1:1 to receive either high dosage Withania somnifera extract (1088 mg daily), medium dosage Withania somnifera extract (544 mg daily) or matching placebo. The study will consist of a Screening Period, Randomization visit, Baseline visit, and Follow-up visits. The treatment period will be 8 weeks and a final follow up call will occur at Week 9.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dosage Withania somnifera | Experimental | Drug: Withania somnifera544mg oral twice a day |
| Medium dosage Withania somnifera | Experimental | Drug: Withania somnifera272mg oral twice a day |
| Placebo | Placebo comparator | Drug: PlaceboMatched capsules twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosed with laboratory supported probable, clinically possible, probable or definite ALS according to the World Federation of Neurology Revised El Escorial criteria (83) (Appendix A)
- Disease duration from symptom onset no greater than 36 months at the Screening Visit
- Aged 18 years or older
- Capable of providing informed consent and complying with study procedures
- If taking riluzole, on a stable dose for at least 30 days prior to Screening Visit
Key exclusion criteria (16 listed)
- Exposure to any investigational agent or Withania somnifera (Ashwagandha) within 30 days prior to the Screening Visit; simultaneous participation in other observational studies is allowed upon Site Investigator approval
- Presence of any of the following clinical conditions:
- Hypersensitivity or allergy to Withania somnifera
- Uncontrolled diabetes with severe associated complications (such as neuropathy)
- Untreated hypertension, active stomach ulcers, or untreated thyroid disorder
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 |
|---|---|---|
| Withania somniferaNuclear Factor Kappa Beta Inhibitor | Drug | High dosage Withania somnifera, Medium dosage Withania somnifera |
| PlaceboPlacebo Comparator | Drug | Placebo |
Primary outcome
Incidence of adverse events (safety)
Time frame: From Baseline visit until end of study visit (Week 9)
Incidence of adverse events
4 secondary outcomes
Change in SICI values
Time frame: Baseline to 8 weeks
Change in RMT values
Time frame: Baseline to 8 weeks
Change in recovery cycle
Time frame: Baseline to 8 weeks
Change in strength duration time constant
Time frame: Baseline to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
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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.
Agessandro Abrahao, MD, MSc principal investigator
Sunnybrook Research Institute, University of Toronto
Lorne Zinman, MD, MSc study director
Sunnybrook Research Institute, University of Toronto
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 Withania somnifera in people with ALS, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 9 inclusion and 16 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 6 Jun 2022. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jake Wimmer (416-480-6100 ext. 87561, jake.wimmer@sri.utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (safety) (time frame: From Baseline visit until end of study visit (Week 9)). 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 6 Jun 2022.