Parkinson's DiseasePhase 1/2NCT01491022
A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease
A Phase 1/2 study of Parkinson's Disease, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of AMPYRA on a number of symptoms in Parkinson's disease. AMPYRA is a medication approved by FDA for gait dysfunction in multiple sclerosis. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Parkinson's Disease
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jul 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic PD with stage Hoehn and Yahr Stage>2-3 and with gait freezing or postural instability.
- On stable dosage dopamine agonist/levodopa, and expected to remain on the same dosage of treatment for the duration of study
- Age less than 80, onset of disease at age more than 45.
- Able to give consent
Who cannot join
- Past medical history of seizures,
- History of renal insufficiency,
- History of cardiac arrhythmia,
- Severe arthritis,
- Women of childbearing potential,
- Cognitive impairment
Show all 10Show fewer
- Age more than 80.
- PD patients stage 4 H\&Y
- PD patient with recent introduction of dopamine agonist or IMAO B
- PD patients participating in other studies
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effect of AMPYRA on a number of symptoms in Parkinson's disease. AMPYRA is a medication approved by FDA for gait dysfunction in multiple sclerosis. There are multiple studies to suggest that persons with multiple sclerosis benefit from this medication and have major improvements in gait after taking this medication. However, this medication was never studied in Parkinson's disease. This study aims to learn about possible benefits of AMPYRA in Parkinson's disease (PD).
Read the detailed description
Subjects with Parkinson's disease will be randomly assigned to two groups. One group will receive Ampyra first for 4 weeks, followed by 2 weeks break and than 4 weeks placebo while the second group will first receive placebo and then Ampyra.
- Conditions
- Parkinson's Disease
- Being tested
- Ampyra first, then Placebo, placebo first, then Ampyra
- Keywords
- parkinson's, gait dysfunction, ampyra, 4-aminopyridine
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ampyra first, then PlaceboDrug
Also called first intervention
10 mg po bid for 4 weeks followed by placebo 4 weeks.
placebo first, then AmpyraDrug
Also called second intervention
placebo
| Study group | Role | What they receive |
|---|---|---|
| Ampyra | Experimental | Ampyra 10 mg po BID for 4 weeks followed by placebo 4 weeks Receives: Drug: Ampyra first, then Placebo |
| Placebo | Sham comparator | placebo 4 weeks followed by Ampyra 10 mg po BID Receives: Drug: placebo first, then Ampyra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Velocity
The primary outcome measure will be the change in gait velocity as measured with by 3-dimensional gait analysis system.
Measured: baseline and 4 weeks
Secondary outcomes (5)
United Parkinson's Disease Rating Scale Score(UPDRS) ,
change in UPDRS score (motor) range 0-104, where 0 is good and 104 is worse.
Measured: 4 weeks
Freezing of Gait Questionnaire (FOGQ)
change in FOGQ score 0- 16, where 0 is normal, 16 is severely impaired
Measured: 4 weeks
Timed Up and Go (TUG) Score
time required to perform TUG.
Measured: 4 weeks
Timed 25-foot Walk Test (T25FW)
time required to perform T25FW.
Measured: 4 weeks
Change in Stride Legth
change in stride length as measured by 3 D capture analysis
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startJul 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Acorda Therapeutics
- Responsible party
- Principal investigator, Corneliu C Luca, University of Miami
- Investigators
- Corneliu Luca, Study chair, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491022
- Sponsor's protocol ID
- 20110173
- Status last verified
- Dec 2017
- First submitted
- 8 Dec 2011
- Last updated
- 2 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01491022
- Acronym / sponsor ID
- 20110173
- Conditions
- Parkinson's Disease
- Keywords
- parkinson's, gait dysfunction, ampyra, 4-aminopyridine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Acorda Therapeutics
- Study start
- Jul 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 13 Dec 2011 (estimated)
- Results
- Posted 13 Apr 2017
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 this study is to evaluate the effect of AMPYRA on a number of symptoms in Parkinson's disease. AMPYRA is a medication approved by FDA for gait dysfunction in multiple sclerosis. There are multiple studies to suggest that persons with multiple sclerosis benefit from this medication and have major improvements in gait after taking this medication. However, this medication was never studied in Parkinson's disease. This study aims to learn about possible benefits of AMPYRA in Parkinson's disease (PD).
Detailed description
Subjects with Parkinson's disease will be randomly assigned to two groups. One group will receive Ampyra first for 4 weeks, followed by 2 weeks break and than 4 weeks placebo while the second group will first receive placebo and then Ampyra.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ampyra | Experimental | Drug: Ampyra first, then PlaceboAmpyra 10 mg po BID for 4 weeks followed by placebo 4 weeks |
| Placebo | Sham comparator | Drug: placebo first, then Ampyraplacebo 4 weeks followed by Ampyra 10 mg po BID |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Idiopathic PD with stage Hoehn and Yahr Stage>2-3 and with gait freezing or postural instability.
- On stable dosage dopamine agonist/levodopa, and expected to remain on the same dosage of treatment for the duration of study
- Age less than 80, onset of disease at age more than 45.
- Able to give consent
Key exclusion criteria (10 listed)
- Past medical history of seizures,
- History of renal insufficiency,
- History of cardiac arrhythmia,
- Severe arthritis,
- Women of childbearing potential,
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 |
|---|---|---|
| Ampyra first, then PlaceboAlso: first intervention10 mg po bid for 4 weeks followed by placebo 4 weeks. | Drug | Ampyra |
| placebo first, then AmpyraAlso: second interventionplacebo | Drug | Placebo |
Primary outcome
Change in Velocity
Time frame: baseline and 4 weeks
The primary outcome measure will be the change in gait velocity as measured with by 3-dimensional gait analysis system.
5 secondary outcomes
United Parkinson's Disease Rating Scale Score(UPDRS) ,
Time frame: 4 weeks
Freezing of Gait Questionnaire (FOGQ)
Time frame: 4 weeks
Timed Up and Go (TUG) Score
Time frame: 4 weeks
Timed 25-foot Walk Test (T25FW)
Time frame: 4 weeks
Change in Stride Legth
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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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.
Corneliu Luca study chair
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study of Parkinson's Disease, run by University of Miami 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 4 inclusion and 10 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 2 Jan 2018. 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. 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 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?
Yes. Results are posted in the registry (first posted 13 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Velocity (time frame: baseline and 4 weeks). 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 2 Jan 2018.