Parkinson's DiseasePhase 2MOBILENCT00442780
Dose-Finding Safety Study of BIIB014 in Early-Stage Parkinson's Disease
A Phase 2 study testing BIIB014 in people with Parkinson's Disease, run by Biogen at 10 sites in 3 countries.
Trial summary
The main purpose of this study is to determine the safety of BIIB014 and how well BIIB014 is tolerated when given at different doses to patients with early-stage Parkinson's Disease. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- BIIB014
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Aug 2007to Dec 2008
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must give written informed consent and any authorizations required by local law.
- Must carry a diagnosis of idiopathic Parkinson's Disease(PD), without any other known or suspected cause of parkinsonism, according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria. Initial diagnosis of PD must have been made within the 5 years prior to Screening with at least two or more of the following cardinal signs being present: bradykinesia, resting tremor, rigidity, and postural instability.
- Must be modified Hoehn \& Yahr Stage 1 to 2.5 (inclusive).
- Must have a baseline UPDRS (Part III) motor score of at least 10.
- Subjects may be receiving an anticholinergic agent and/or MAO-B inhibitor (if they have been on a stable dose of that medication for at least 4 weeks prior to study entry) but must not be receiving any other PD medication.
Who cannot join
- A Mini Mental State Examination (MMSE) score <26.
- History or clinical features consistent with an atypical parkinsonian syndrome.
- Any significant non-PD central nervous system disorder.
- Any significant AXIS I psychiatric disease as defined by the Diagnostic and Statistical Manual of Mental Disorders.
- History of cognitive or neuropsychiatric conditions.
- History of surgical intervention for PD.
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- History of L-DOPA-induced motor or non-motor complication.
- History of malignancy.
- History of severe allergic or anaphylactic reactions to any drug.
- Clinically significant renal dysfunction.
- HbA1c >7.0%.
- Clinically significant baseline ECG.
- Orthostatic hypotension.
- Treatment with L-DOPA/carbidopa or L-DOPA/benserazide for more than 6 cumulative months at anytime since subject's initial PD diagnosis.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Israel4 sites
Research Site
Ashkelon
Research Site
Petah Tikva
Research Site
Ramat Gan
Research Site
Tel Aviv
Poland4 sites
Research Site
Kielce
Research Site
Krakow
Research Site
Poznan
Research Site
Warsaw
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Multiple Doses of BIIB014 Administered Orally in Subjects With Early Parkinson's Disease
The main purpose of this study is to determine the safety of BIIB014 and how well BIIB014 is tolerated when given at different doses to patients with early-stage Parkinson's Disease.
This study will also explore:
Read more
- How BIIB014 is affected when given to patients with early-stage Parkinson's Disease (this will be done by measuring the levels of BIIB014 in the blood at several different times during the study), and
- The activity of BIIB014 when given to early Parkinson's patients (this will be done by performing different Parkinson's Disease assessments and other tests during the study).
Patients who enter this study will be randomly assigned to receive either BIIB014 or a placebo but because the study is blinded, neither they nor their study doctor will know which study treatment they are taking.
- Conditions
- Parkinson's Disease
- Being tested
- BIIB014, Placebo
- Keywords
- early Parkinson's Disease, MOBILE, BIIB014
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB014Drug
oral administration of BIIB014 per dose, schedule,and duration specified in protocol
PlaceboDrug
Oral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Dose Level A of BIIB014 Receives: Drug: BIIB014; Drug: Placebo |
| 2 | Placebo comparator | Dose Level B of BIIB014 Receives: Drug: BIIB014; Drug: Placebo |
| 3 | Placebo comparator | Dose Level C of BIIB014 Receives: Drug: BIIB014; Drug: Placebo |
| 4 | Placebo comparator | Dose Level D of BIIB014 Receives: Drug: BIIB014; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and proportion of subjects with adverse events
Measured: up to end of study
Assessment of clinical laboratory parameters.
Measured: up to end of study
Assessment of vital signs.
Measured: up to end of study
Assessment of ECG parameters.
Measured: up to end of study
Secondary outcomes (3)
Assess PK by measuring concentrations of BIIB014 and its N-acetyl metabolite in blood plasma.
Measured: up to end of study
Explore BIIB014 activity by evaluating standard Parkinson's disease assessments.
Measured: up to end of study
Explore the PK/pharmacodynamic relationships for BIIB014.
Measured: up to end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by BiogenThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Biogen Idec, MD, Study director, Cambridge, MA USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442780
- Sponsor's protocol ID
- 204PD203
- Other IDs
- EUDRA CT NO: 2007-000398-47
- Acronym
- MOBILE
- Status last verified
- Jan 2009
- First submitted
- 1 Mar 2007
- Last updated
- 9 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Multiple Doses of BIIB014 Administered Orally in Subjects With Early Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00442780
- Acronym / sponsor ID
- MOBILE / 204PD203
- Conditions
- Parkinson's Disease
- Keywords
- early Parkinson's Disease, MOBILE, BIIB014
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 2 Mar 2007 (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 main purpose of this study is to determine the safety of BIIB014 and how well BIIB014 is tolerated when given at different doses to patients with early-stage Parkinson's Disease.
This study will also explore:
- How BIIB014 is affected when given to patients with early-stage Parkinson's Disease (this will be done by measuring the levels of BIIB014 in the blood at several different times during the study), and
- The activity of BIIB014 when given to early Parkinson's patients (this will be done by performing different Parkinson's Disease assessments and other tests during the study).
Patients who enter this study will be randomly assigned to receive either BIIB014 or a placebo but because the study is blinded, neither they nor their study doctor will know which study treatment they are taking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: BIIB014, Drug: PlaceboDose Level A of BIIB014 |
| 2 | Placebo comparator | Drug: BIIB014, Drug: PlaceboDose Level B of BIIB014 |
| 3 | Placebo comparator | Drug: BIIB014, Drug: PlaceboDose Level C of BIIB014 |
| 4 | Placebo comparator | Drug: BIIB014, Drug: PlaceboDose Level D of BIIB014 |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must give written informed consent and any authorizations required by local law.
- Must carry a diagnosis of idiopathic Parkinson's Disease(PD), without any other known or suspected cause of parkinsonism, according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria. Initial diagnosis of PD must have been made within the 5 years prior to Screening with at least two or more of the following cardinal signs being present: bradykinesia, resting tremor, rigidity, and postural instability.
- Must be modified Hoehn \& Yahr Stage 1 to 2.5 (inclusive).
- Must have a baseline UPDRS (Part III) motor score of at least 10.
- Subjects may be receiving an anticholinergic agent and/or MAO-B inhibitor (if they have been on a stable dose of that medication for at least 4 weeks prior to study entry) but must not be receiving any other PD medication.
Key exclusion criteria (14 listed)
- A Mini Mental State Examination (MMSE) score <26.
- History or clinical features consistent with an atypical parkinsonian syndrome.
- Any significant non-PD central nervous system disorder.
- Any significant AXIS I psychiatric disease as defined by the Diagnostic and Statistical Manual of Mental Disorders.
- History of cognitive or neuropsychiatric conditions.
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 |
|---|---|---|
| BIIB014oral administration of BIIB014 per dose, schedule,and duration specified in protocol | Drug | 1, 2, 3, 4 |
| PlaceboOral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014 | Drug | 1, 2, 3, 4 |
Primary outcome
Number and proportion of subjects with adverse events
Time frame: up to end of study
Assessment of clinical laboratory parameters.
Time frame: up to end of study
Assessment of vital signs.
Time frame: up to end of study
Assessment of ECG parameters.
Time frame: up to end of study
3 secondary outcomes
Assess PK by measuring concentrations of BIIB014 and its N-acetyl metabolite in blood plasma.
Time frame: up to end of study
Explore BIIB014 activity by evaluating standard Parkinson's disease assessments.
Time frame: up to end of study
Explore the PK/pharmacodynamic relationships for BIIB014.
Time frame: up to end of study
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 9 Jan 2009.
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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.
Biogen Idec, MD study director
Cambridge, MA USA
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIIB014 in people with Parkinson's Disease, run by Biogen at 10 sites in 3 countries.
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 5 inclusion and 14 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 9 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Israel, Poland, Serbia. 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 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?
Number and proportion of subjects with adverse events (time frame: up to end of study). The study lists 4 primary outcomes in all. 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 Jan 2009.