Amyotrophic Lateral SclerosisPhase 2/3NCT01825551
The Effect of GCSF in the Treatment of ALS Patients
A Phase 2/3 study testing Granulocyte Colony Stimulating Factor in people with Amyotrophic Lateral Sclerosis, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of this study is to evaluate the effect off Granulocyte Colony Stimulating Factor (GCSF) in the treatment of Amyotrophic Lateral Sclerosis (ALS) patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Granulocyte Colony Stimulating Factor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- Nov 2012to Nov 2013
- Phase
- Phase 2/3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 85
- definite or probable ALS according to revised El Escorial criteria
- maximum 2 years from initiation of symptoms to study entry
- mild to moderate disability according to revised ALS functional rating scale (ALSFRS-r)
Who cannot join
- familial ALS
- pregnancy or lactation
- myeloproliferative or hematologic disorders
- active immunological disease
- liver or renal or heart disease
- HIV positive
- significant cognitive disorder
- hypersensitivity to GCSF
Trial locations and contacts
1 site in 1 country.
Iran1 site
Iranian Neurology Research Center of Tehran University of Medical Sciences
Tehran, Tehran Province
About this study
Official title: The Effect of Granulocyte Colony Stimulating Factor (GCSF) in the Treatment of Amyotrophic Lateral Sclerosis (ALS) Patients Referred to Tehran Imam Khomeini and Shariati Hospital Centers in 2013
The aim of this study is to evaluate the effect off Granulocyte Colony Stimulating Factor (GCSF) in the treatment of Amyotrophic Lateral Sclerosis (ALS) patients.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Granulocyte Colony Stimulating Factor, Placebo
- Keywords
- Amyotrophic Lateral Sclerosis, Granulocyte Colony Stimulating Factor
- 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.
Granulocyte Colony Stimulating FactorDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Granulocyte Colony Stimulating Factor | Active comparator | Granulocyte Colony Stimulating Factor 10 microgram/ kg/ day for 5 days subcutaneously Receives: Drug: Granulocyte Colony Stimulating Factor |
| Placebo | Placebo comparator | normal saline 0.01 ml/kg/day for 5 days subcutaneously Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient's function
based on revised ALS Functional Rating scale (ALSFRS-r)
Measured: one year
Secondary outcomes (4)
mobilizing bone marrow stem cells
based on cluster of differentiation 34 (CD34) and white blood cell (WBC) counting
Measured: 1 year
amplitude of compound muscle action potential in ulnar and peroneal nerve
based on compound muscle action potential (CMAP) measured in nerve conduction study
Measured: 1 year
quality of life
based on Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ40)
Measured: 1 year
muscle power
based on Muscle Manual Test (MMT)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startNov 2012
- Primary completionNov 2013
- Study completionNov 2013
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825551
- Sponsor's protocol ID
- 91-01-54-17265
- Status last verified
- Nov 2013
- First submitted
- 13 Mar 2013
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Granulocyte Colony Stimulating Factor (GCSF) in the Treatment of Amyotrophic Lateral Sclerosis (ALS) Patients Referred to Tehran Imam Khomeini and Shariati Hospital Centers in 2013
- ClinicalTrials.gov ID
- NCT01825551
- Acronym / sponsor ID
- 91-01-54-17265
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic Lateral Sclerosis, Granulocyte Colony Stimulating Factor
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 5 Apr 2013 (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 aim of this study is to evaluate the effect off Granulocyte Colony Stimulating Factor (GCSF) in the treatment of Amyotrophic Lateral Sclerosis (ALS) patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Granulocyte Colony Stimulating Factor | Active comparator | Drug: Granulocyte Colony Stimulating FactorGranulocyte Colony Stimulating Factor 10 microgram/ kg/ day for 5 days subcutaneously |
| Placebo | Placebo comparator | Drug: Placebonormal saline 0.01 ml/kg/day for 5 days subcutaneously |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age between 18 and 85
- definite or probable ALS according to revised El Escorial criteria
- maximum 2 years from initiation of symptoms to study entry
- mild to moderate disability according to revised ALS functional rating scale (ALSFRS-r)
Key exclusion criteria (8 listed)
- familial ALS
- pregnancy or lactation
- myeloproliferative or hematologic disorders
- active immunological disease
- liver or renal or heart disease
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 |
|---|---|---|
| Granulocyte Colony Stimulating Factor | Drug | Granulocyte Colony Stimulating Factor |
| Placebo | Drug | Placebo |
Primary outcome
patient's function
Time frame: one year
based on revised ALS Functional Rating scale (ALSFRS-r)
4 secondary outcomes
mobilizing bone marrow stem cells
Time frame: 1 year
amplitude of compound muscle action potential in ulnar and peroneal nerve
Time frame: 1 year
quality of life
Time frame: 1 year
muscle power
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Granulocyte Colony Stimulating Factor in people with Amyotrophic Lateral Sclerosis, run by Tehran University of Medical Sciences 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 8 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: finished, as of the sponsor's last update on 13 Nov 2013. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
patient's function (time frame: one year). 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 13 Nov 2013.