Amyotrophic Lateral SclerosisPhase 1/2NCT00140218
R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis
A Phase 1/2 study testing R(+) pramipexole dihydrochloride monohydrate in people with Amyotrophic Lateral Sclerosis, run by Bennett, James P., Jr., M.D., Ph.D. at 2 sites in United States.
Trial summary
The hypothesis of this study is that treatment with R(+) pramipexole at 30 mg/day will alter the slope of decline in ALS functional rating scale over the course of 6 months. ALS patients at an early stage of disease will be observed for 3 months after enrollment and then treated with drug for 6 months. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- R(+) pramipexole dihydrochloride monohydrate
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2005to Dec 2006
- Phase
- Phase 1/2
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- established diagnosis of ALS FVC>60% of predicted not being ventilated no difficulty swallowing ambulatory (can use assistance devices)
Who cannot join
- ALS duration >3 years advanced ALS with survival predicted <6 months dementia (MMSE<22) prior exposure to R(+) pramipexole orthostatic hypotension >30 mmHg history of psychosis or hallucinations abnormal baseline safety lab values
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Virginia
Charlottesville, Virginia, 22908
David Lacomis MD
Pittsburgh, Pennsylvania
About this study
Official title: Futility Study of R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis
The hypothesis of this study is that treatment with R(+) pramipexole at 30 mg/day will alter the slope of decline in ALS functional rating scale over the course of 6 months. ALS patients at an early stage of disease will be observed for 3 months after enrollment and then treated with drug for 6 months.
Read the detailed description
This is a futility design Phase II study using ALS-FRSr as the primary variable to monitor progression of disease in patients with early ALS. The drug to be tested is R(+) pramipexole, an antioxidant that concentrates into brain and mitochondria. R(+)PPX will be administered at 30 mg/day over 6 months, following a 3 month lead-in period without drug therapy. For purposes of this study, futility is defined as failure to decrease the slope of ALS-FRSr decline by less than 40%.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- R(+) pramipexole dihydrochloride monohydrate
- Keywords
- amyotrophic lateral sclerosis, pramipexole, oxidative stress, neuroprotection
- 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.
R(+) pramipexole dihydrochloride monohydrateDrug
10 mg tid oral
What is being measured
The primary outcome is the main question the study is designed to answer.
ALS-FRSr score taken each month for 3 months during lead-in and for 6 months during treatment
Measured: -3 -2 -1 0 1 2 3 4 5 6 months
Secondary outcomes (2)
FVC taken each month
Measured: -3 -2 -1 0 1 2 3 4 5 6 months
hand dynamometry taken each month
Measured: -3 -2 -1 0 1 2 3 4 5 6
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 startAug 2005
- Primary completionJan 2007
- Study completionDec 2006
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bennett, James P., Jr., M.D., Ph.D.
- Collaborators
- University of Pittsburgh
- Investigators
- Lawrence H Phillips, M.D., Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140218
- Sponsor's protocol ID
- 11736
- Status last verified
- Jan 2008
- First submitted
- 30 Aug 2005
- Last updated
- 8 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Futility Study of R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT00140218
- Acronym / sponsor ID
- 11736
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- amyotrophic lateral sclerosis, pramipexole, oxidative stress, neuroprotection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bennett, James P., Jr., M.D., Ph.D.
- Collaborators
- University of Pittsburgh
- Study start
- Aug 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Dec 2006 (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 hypothesis of this study is that treatment with R(+) pramipexole at 30 mg/day will alter the slope of decline in ALS functional rating scale over the course of 6 months. ALS patients at an early stage of disease will be observed for 3 months after enrollment and then treated with drug for 6 months.
Detailed description
This is a futility design Phase II study using ALS-FRSr as the primary variable to monitor progression of disease in patients with early ALS. The drug to be tested is R(+) pramipexole, an antioxidant that concentrates into brain and mitochondria. R(+)PPX will be administered at 30 mg/day over 6 months, following a 3 month lead-in period without drug therapy. For purposes of this study, futility is defined as failure to decrease the slope of ALS-FRSr decline by less than 40%.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- established diagnosis of ALS FVC>60% of predicted not being ventilated no difficulty swallowing ambulatory (can use assistance devices)
Key exclusion criteria (1 listed)
- ALS duration >3 years advanced ALS with survival predicted <6 months dementia (MMSE<22) prior exposure to R(+) pramipexole orthostatic hypotension >30 mmHg history of psychosis or hallucinations abnormal baseline safety lab values
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 |
|---|---|---|
| R(+) pramipexole dihydrochloride monohydrate10 mg tid oral | Drug | – |
Primary outcome
ALS-FRSr score taken each month for 3 months during lead-in and for 6 months during treatment
Time frame: -3 -2 -1 0 1 2 3 4 5 6 months
2 secondary outcomes
FVC taken each month
Time frame: -3 -2 -1 0 1 2 3 4 5 6 months
hand dynamometry taken each month
Time frame: -3 -2 -1 0 1 2 3 4 5 6
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 8 Jan 2008.
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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.
Lawrence H Phillips, M.D. principal investigator
University of Virginia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing R(+) pramipexole dihydrochloride monohydrate in people with Amyotrophic Lateral Sclerosis, run by Bennett, James P., Jr., M.D., Ph.D. at 2 sites 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 1 inclusion and 1 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 8 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined 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.
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?
ALS-FRSr score taken each month for 3 months during lead-in and for 6 months during treatment (time frame: -3 -2 -1 0 1 2 3 4 5 6 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 8 Jan 2008.