Amyotrophic Lateral SclerosisPhase 2NCT00140452
Phase II Study Using Thalidomide for the Treatment of ALS
A Phase 2 study testing Thalidomide in people with Amyotrophic Lateral Sclerosis and ALS, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The use of Thalidomide in patients with ALS who have disease progression. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, ALS
- What is being tested?
- Thalidomide
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Nov 2007
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically proven ALS
- Disease duration less than or equal to 5 years
- ALSFRS-R score equal to or greater then 30
Who cannot join
- Patients with known deep venous thrombosis or hyper coagulable state will be excluded
- Patients with FVC less than 80%
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Hichcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: Phase II Study Using Thalidomide for the Treatment of Amyotrophic Lateral Sclerosis
The use of Thalidomide in patients with ALS who have disease progression.
Read the detailed description
Phase II open labeled trial testing the efficacy of thalidomide for ALS in the setting of disease progression.
- Conditions
- Amyotrophic Lateral Sclerosis, ALS
- Being tested
- Thalidomide
- Keywords
- ALS
- 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.
ThalidomideDrug
Thalidomide will start at a dose of 100mg/day, dose escalated every 2 weeks by 100mg/day to a target dose of 400mg/day.
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of Thalidomide in the rate of progression in ALS at 9 months and hence determine preliminary efficacy in the treatment of ALS
Measured: Efficacy will be gauged according to the slopeof the expected average decline at nine months after starting Thalidomide
Secondary outcomes (1)
To evaluate 1) toxicity 2) quality of life 3) cytokine profile 4) PFT's 5) sleep questionnaire and 6) survival of thalidomide in the treatment of ALS
Measured: survival and progression free suvival will be assessed from the date of initial therapy on study to date od death. Survival and progresion free survival wil be analyzed using the Kaplan Meier method
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startFeb 2005
- Study completionNov 2007
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.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Investigators
- Elijah Stommel, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140452
- Sponsor's protocol ID
- ALS-001
- Status last verified
- Nov 2007
- First submitted
- 31 Aug 2005
- Last updated
- 21 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Using Thalidomide for the Treatment of Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT00140452
- Acronym / sponsor ID
- ALS-001
- Conditions
- Amyotrophic Lateral Sclerosis, ALS
- Keywords
- ALS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Feb 2005
- Study completion
- Nov 2007 (actual)
- First posted
- 1 Sep 2005 (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 use of Thalidomide in patients with ALS who have disease progression.
Detailed description
Phase II open labeled trial testing the efficacy of thalidomide for ALS in the setting of disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinically proven ALS
- Disease duration less than or equal to 5 years
- ALSFRS-R score equal to or greater then 30
Key exclusion criteria (2 listed)
- Patients with known deep venous thrombosis or hyper coagulable state will be excluded
- Patients with FVC less than 80%
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 |
|---|---|---|
| ThalidomideThalidomide will start at a dose of 100mg/day, dose escalated every 2 weeks by 100mg/day to a target dose of 400mg/day. | Drug | – |
Primary outcome
To evaluate the effect of Thalidomide in the rate of progression in ALS at 9 months and hence determine preliminary efficacy in the treatment of ALS
Time frame: Efficacy will be gauged according to the slopeof the expected average decline at nine months after starting Thalidomide
1 secondary outcome
To evaluate 1) toxicity 2) quality of life 3) cytokine profile 4) PFT's 5) sleep questionnaire and 6) survival of thalidomide in the treatment of ALS
Time frame: survival and progression free suvival will be assessed from the date of initial therapy on study to date od death. Survival and progresion free survival wil be analyzed using the Kaplan Meier method
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 21 Nov 2007.
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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.
Elijah Stommel principal investigator
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 Thalidomide in people with Amyotrophic Lateral Sclerosis and ALS, run by Dartmouth-Hitchcock Medical Center at 1 site 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?
The sponsor lists 3 inclusion and 2 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 21 Nov 2007. 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 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. 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 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?
To evaluate the effect of Thalidomide in the rate of progression in ALS at 9 months and hence determine preliminary efficacy in the treatment of ALS (time frame: Efficacy will be gauged according to the slopeof the expected average decline at nine months after starting Thalidomide). 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 21 Nov 2007.