Amyotrophic Lateral SclerosisPhase 1ALS-PHLNCT02588807
Food Supplement for the Treatment of Patients With Amyotrophic Lateral Sclerosis
A Phase 1 study testing Spirit1 in people with Amyotrophic Lateral Sclerosis, run by Herb Spirit at 1 site in Israel.
Trial summary
The purpose of the study is to evaluate the safety of combining phospholipids with medicinal plants for treatment of patients with amyotrophic lateral sclerosis (ALS) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Spirit1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2021to May 2022
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males aged 18 to 75 years, Females>50 years
- Diagnosis of "probable" or "definite" ALS according to the El Escorial revised criteria
- A documented history of ALS symptoms for more than 6 month prior to study enrolment, and no more than 40 month.
- Patients capable of understanding and signing Informed Consent.
Who cannot join
- Patients allergic to seafood
- Patients with forced vital capacity < 75%
- Patients who are respiratory dependent, underwent tracheostomy, or cannot swallow.
- Patients with cardiovascular diseases
- Patients with diabetes
- Patients with active peptic ulcers
Show all 11Show fewer
- Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc).
- Patients suffering from other chronic significant disease, malignant diseases or any other disease that may risk the patient or interfere with the ability to interpret the results.
- Patients that can not sign/understand the Informed Consent Form.
- Female patients who are pregnant or lactating
- Patients who have received and experimental drug or have participated in a clinical trial within 1 month prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Combination of Phospholipids and Medical Herbs for the Treatment of Patients With Amyotrophic Lateral Sclerosis (ALS); A Pilot Study
The purpose of the study is to evaluate the safety of combining phospholipids with medicinal plants for treatment of patients with amyotrophic lateral sclerosis (ALS)
Read the detailed description
This is an open label pilot study, where patients (n=10) with ALS will take a daily nutritional supplement for 8 months. After documenting the ALS symptom history at baseline, the disease severity, and the motor muscles functions will be assessed at baseline and every two months (0, 2 , 4, 6, 8 months of the treatment). Adverse events and side effect will be assessed on every visit and throughout the experiment. In addition, the level of renal function, liver function and electrolytes will be evaluated from blood samples taken at baseline, 4, and 8 months visits.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Spirit1
- 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.
Spirit1Drug
Spirit 1 is a combination of phospholipids and anti-oxidant medicinal plants
| Study group | Role | What they receive |
|---|---|---|
| Spirit1 | Experimental | Patients will take a daily nutritional supplement for 8 months Receives: Drug: Spirit1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability and safety based on the number and severity of adverse events (AE)
Tolerability and safety evaluations will be based on the documentation of the incidence and severity of short term, and long term side effects, and adverse events (AEs) as well as changes in results of blood tests (increase in levels of liver enzymes, decrease in renal function, changes in complete blood count and electrolytes).
Measured: 8 months
Secondary outcomes (4)
Change from baseline in score on the ALS Functional Rating Scale Revised (ALS-FRSr)
The ALS-FRS-R is an instrument for evaluating the activities of daily living and global function of patients with ALS. It is used to monitor functional change in a patient over time and includes 12 questions. Each question has 5 possible responses (0-indicates unable to 4-indicates normal ability). Individual item scores are added to produce a reported score of between 0 = worst and 48 = best.
A change of ≥25% is considered a clinically meaningful deterioration.
Measured: 4, 8 months
Change from baseline in Forced vital capacity (FVC)
The purpose of this test is to assess the extent of respiratory muscle fatigue. The amount and/or speed (volume and flow respectively) of air that can be inhaled and exhaled will be measured by a commercial spirometer. Vital Capacity is the maximum amount of air a person can expel from the lungs after a maximum inhalation.
Measured: 2, 4, 6, 8 months
Change from baseline in hand grip power using a dynamometer
The purpose of this test is to measure the maximum isometric strength of the hand and forearm muscles. The subject holds a commercial dynamometer in the hand to be tested, with the arm at right angles and the elbow by the side of the body. When ready the patient will be asked to squeezes the dynamometer with maximum force which is maintained for 3 seconds. This will be repeated 3 times in each hand. The best result from several trials for each hand is recorded, with at least 15 seconds recovery between each effort.
Measured: 2, 4, 6, 8 months
Change from baseline in walking speed for 10 meters
The purpose of this test is to measure the lower extremities muscle strength. The patients will be asked to walk a distance of 10 meters in their maximal speed. The time to walk this distance will represent the lower extremities muscle strength.
Measured: 2, 4, 6, 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study start1 Jan 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionMay 2022 (estimated)
Why it stopped: The sponsor and hospital did not reach agreement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herb Spirit
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Carmel Medical Center
- Responsible party
- Sponsor
- Investigators
- Jacob Meer, MD, Principal investigator, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588807
- Sponsor's protocol ID
- 0015-14-CMC
- Acronym
- ALS-PHL
- Status last verified
- Aug 2022
- First submitted
- 27 Oct 2015
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combination of Phospholipids and Medical Herbs for the Treatment of Patients With Amyotrophic Lateral Sclerosis (ALS); A Pilot Study
- ClinicalTrials.gov ID
- NCT02588807
- Acronym / sponsor ID
- ALS-PHL / 0015-14-CMC
- Conditions
- Amyotrophic Lateral Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The sponsor and hospital did not reach agreement
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Herb SpiritIndustry (pharma, biotech, devices)
- Collaborators
- Carmel Medical Center
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 28 Oct 2015 (estimated)
- 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.
The purpose of the study is to evaluate the safety of combining phospholipids with medicinal plants for treatment of patients with amyotrophic lateral sclerosis (ALS)
Detailed description
This is an open label pilot study, where patients (n=10) with ALS will take a daily nutritional supplement for 8 months. After documenting the ALS symptom history at baseline, the disease severity, and the motor muscles functions will be assessed at baseline and every two months (0, 2 , 4, 6, 8 months of the treatment). Adverse events and side effect will be assessed on every visit and throughout the experiment. In addition, the level of renal function, liver function and electrolytes will be evaluated from blood samples taken at baseline, 4, and 8 months visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spirit1 | Experimental | Drug: Spirit1Patients will take a daily nutritional supplement for 8 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males aged 18 to 75 years, Females>50 years
- Diagnosis of "probable" or "definite" ALS according to the El Escorial revised criteria
- A documented history of ALS symptoms for more than 6 month prior to study enrolment, and no more than 40 month.
- Patients capable of understanding and signing Informed Consent.
Key exclusion criteria (11 listed)
- Patients allergic to seafood
- Patients with forced vital capacity < 75%
- Patients who are respiratory dependent, underwent tracheostomy, or cannot swallow.
- Patients with cardiovascular diseases
- Patients with diabetes
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 |
|---|---|---|
| Spirit1Spirit 1 is a combination of phospholipids and anti-oxidant medicinal plants | Drug | Spirit1 |
Primary outcome
Tolerability and safety based on the number and severity of adverse events (AE)
Time frame: 8 months
Tolerability and safety evaluations will be based on the documentation of the incidence and severity of short term, and long term side effects, and adverse events (AEs) as well as changes in results of blood tests (increase in levels of liver enzymes, decrease in renal function, changes in complete blood count and electrolytes).
4 secondary outcomes
Change from baseline in score on the ALS Functional Rating Scale Revised (ALS-FRSr)
Time frame: 4, 8 months
Change from baseline in Forced vital capacity (FVC)
Time frame: 2, 4, 6, 8 months
Change from baseline in hand grip power using a dynamometer
Time frame: 2, 4, 6, 8 months
Change from baseline in walking speed for 10 meters
Time frame: 2, 4, 6, 8 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 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.
Jacob Meer, MD principal investigator
Carmel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Spirit1 in people with Amyotrophic Lateral Sclerosis, run by Herb Spirit at 1 site in Israel.
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 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: withdrawn, as of the sponsor's last update on 9 Aug 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 Israel. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 withdrawn before enrolling participants, so there are no results.
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?
Tolerability and safety based on the number and severity of adverse events (AE) (time frame: 8 months). 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 9 Aug 2022.