Early Stage Parkinson's DiseasePhase 2NCT00623324
The Effects of Aplindore on the Treatment of Signs and Symptoms of Parkinson's Disease
A Phase 2 study testing Aplindore in people with Early Stage Parkinson's Disease, run by Ligand Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate the safety, tolerability, efficacy and pharmacokinetics of aplindore in patients with early stage Parkinson's Disease (PD) who are not currently taking any dopamine agonists or who are able to wash off dopamine agonists for 14 days prior to baseline. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Early Stage Parkinson's Disease
- What is being tested?
- Aplindore
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jul 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
- Male or female 30 years and above
- 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
- For early stage patients the 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. In addition, they must not have developed motor complications from L-dopa use
- Early stage patients must be modified Hoehn \& Yahr Stage 1 to 3 (inclusive)
- Must have a screening UPDRS (Part III) motor score of at least 10 Patients may be receiving amantadine, anticholinergics, COMT inhibitors and/or MAO-B inhibitor provided the dose was stable for at least 4 weeks prior to screening; dopamine agonists and/or L-dopa/carbidopa are permitted at screening but must be discontinued at least 14 days before baseline
- Good general health as determined by a thorough medical history and physical examination (including vital signs), 12-lead ECG and clinical laboratory tests
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- Patients have clinical laboratory values within normal reference range or must not be clinically significantly abnormal as judged by the Investigator and approved by the Sponsor
- Patients taking prescription drug therapy or OTC medication for chronic medical conditions must be on stable doses for at least two (2) weeks prior to participation in the study and off any investigational drug for at least 60 days
- Females of childbearing potential must be using an acceptable method of contraception, have a negative urine pregnancy test at screening, and a negative urine pregnancy test on admission. Acceptable methods of contraception are oral, intrauterine, implantable, injectable contraceptives, double barrier methods or condoms impregnated with spermicide. After screening, patients using oral contraceptive methods of contraception must agree to add an additional method until 30 days following the last dose of study medication. Women on oral contraceptives must have been using them for at least one month prior to screening
- Male patients with partners of childbearing potential must use adequate contraception for 3 months after the study
- Female patients who have been surgically sterilized or have had a partial oopherectomy (i.e., one ovary intact) are eligible if they have a negative pregnancy test at screening and admission Be able to read, understand, and provide written/dated informed consent before enrolling in the study, and must be willing to comply with all study procedures;
- Patients must be willing and able to be confined to the clinical research unit as required by the protocol
- Patients must refrain from strenuous physical activity beginning 24 hours prior to screening and through the duration of the study
- Smokers may be enrolled if they have stable smoking habits
Who cannot join
- A Mini Mental State Examination (MMSE) score < 26
- History or clinical features consistent with an atypical parkinsonian syndrome
- History of surgical intervention for PD
- History of L-dopa-induced motor or non-motor complication
- History of severe allergic or anaphylactic reactions to any drug
- Clinically significant abnormal baseline ECG; QTcF > 450 msec for males, > 470 msec for females
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- Recent history of severe dizziness or fainting due to postural hypotension; orthostatic blood pressure decrease defined as a drop in systolic BP of ≥ 40 mmHg and or a drop in diastolic BP of ≥ 20 mmHg following 5 minutes supine and 2 minutes standing in conjunction with symptoms.
- Evidence of clinically significant unstable allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric or neurological disease
- History of cancer within 5 years of screening; except basal and squamous cell skin cancers and carcinoma in situ of the cervix
- Any condition that may affect drug absorption
- History of allergies, or known sensitivity, hypersensitivity, or adverse reaction to any drug similar to aplindore
- Pregnant or lactating females
- Recent history or current evidence of drug abuse or alcoholism; or withdrawal
- Introduction or dose change of hormone replacement therapy within 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Dose Ranging, Randomized, Double Blind, Placebo-controlled, Multi-center, Pilot Study to Assess the Safety, Tolerability, Efficacy and Pharmacokinetics of Aplindore in Patients With Early Stage Parkinson's Disease
The purpose of this study is to demonstrate the safety, tolerability, efficacy and pharmacokinetics of aplindore in patients with early stage Parkinson's Disease (PD) who are not currently taking any dopamine agonists or who are able to wash off dopamine agonists for 14 days prior to baseline. Efficacy will be assessed using the UPDRS questionnaire including part 3 of the UPDRS (Motor). their level of sleepiness on a standardized rating scale (Epworth Sleepiness Scale) and their level of nausea daily.
Safety endpoints will include adverse events (AEs), clinical laboratory data, vital signs (blood pressure, orthostatic blood pressure and heart rate), ECGs, physical examinations and self rated scales.
Read the detailed description
The purpose of this study is to demonstrate the safety, tolerability, efficacy and pharmacokinetics of aplindore in 5 groups of 8 patients each with early stage Parkinson's Disease (PD) based on Modified Hoehn and Yahr 1-3, who are not currently taking any dopamine agonists or who are able to wash off dopamine agonists for 14 days prior to baseline. Of the 8 patients in each cohort, 6 will be randomized to receive aplindore and two will receive placebo. The initial cohort of patients will be in the study unit from day -1 through day 15 (~2 weeks). After a review of safety labs and ECGs for Day -1, patients will begin twice a day dosing of investigational product on Day 1 with dosing to be given at within 30 minutes of completing breakfast and dinner, approximately 0700 and 1900.
A full UPDRS evaluation will be conducted at screen and on days -1, 7 and 14. In addition part 3 of the UPDRS (Motor) will be collected daily 2 hours after the morning dose of aplindore/placebo. At screening through discharge patients will be asked to self rate their level of sleepiness on a standardized rating scale (Epworth Sleepiness Scale) and their level of nausea daily 2 hours after the time of the morning dose of aplindore/placebo.
Safety endpoints will include adverse events (AEs), clinical laboratory data, vital signs (blood pressure, orthostatic blood pressure and heart rate), ECGs, physical examinations and self rated scales.
This study is a Phase II, dose-ranging, multi-center, placebo-controlled, double-blind, titration study to determine the safety, tolerability, efficacy and pharmacokinetics of aplindore in 5 groups of 8 patients each with early stage Parkinson's Disease (PD) based on Modified Hoehn and Yahr 1-3, who are not currently taking any dopamine agonists or who are able to wash off dopamine agonists for 14 days prior to baseline. Of the 8 patients in each cohort, 6 will be randomized to receive aplindore and two will receive placebo. The minimum number of patients required to initiate a cohort is 6 patients (4 randomized to aplindore and 2 to placebo). The patients in each cohort will be randomized in blocks of 4. Each site will recruit a full cohort of 6-8 patients per dose-titration regimen. There will be no sharing of cohorts/dose regimens across sites.
Early PD patients will be screened and 6-8 eligible patients will be housed in the study unit from day -1 through day 15 or until dismissed by the investigator. After a repeat of safety labs and ECG, patients will begin q12h dosing of investigational product (IP) with dosing to be given at within 30 minutes of completing breakfast and dinner, approximately 0700 and 1900 starting on Day 1. Doses will be escalated according to a predefined schedule. Two hours after each morning dose, a UPDRS part III will be performed. Safety will be ascertained by adverse events, ECGs, orthostatic vitals, physical and neurological exams, safety labs, Epworth Sleepiness Scale and Non Motor Symptoms Questionnaires. One blood sample for PK will be taken on each escalation day, 11 samples at steady state. ECGs and vital signs (semi-reclined and standing) will be collected each day at 2 hours post morning dosing. Adverse events will be collected throughout the inpatient stay. Patients will be down titrated upon reaching an intolerable dose. Patients on prior dopaminergic medications will resume their prior therapies on Day 15. Those patients not on prior dopaminergic medications will be down titrated over 5-7 days in the research clinic. Outpatient safety follow up will be 7-21 days after the last dose of study medication.
- Conditions
- Early Stage Parkinson's Disease
- Being tested
- Aplindore, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AplindoreDrug
Tablets .05 - 5 mg BID dosing for 14 days
PlaceboDrug
Placebo tablets to match the number of active tablets
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Aplindore titrated to safe and tolerable dose Receives: Drug: Aplindore |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of safety and tolerability data
Measured: 3 weeks
Secondary outcomes (1)
Change in UPDRS Motor (Part III) score, UPDRS Activities of Daily Living (ADL; Part II), the Non-Motor Symptoms Questionnaire, and the Epworth Sleepiness Scale (ESS) and nausea Likert Scale.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Stage Parkinson's DiseaseStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ligand Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623324
- Sponsor's protocol ID
- Aplindore-201
- Other IDs
- Aplindore-201
- Status last verified
- Sep 2011
- First submitted
- 14 Feb 2008
- Last updated
- 3 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Dose Ranging, Randomized, Double Blind, Placebo-controlled, Multi-center, Pilot Study to Assess the Safety, Tolerability, Efficacy and Pharmacokinetics of Aplindore in Patients With Early Stage Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00623324
- Acronym / sponsor ID
- Aplindore-201
- Conditions
- Early Stage Parkinson's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ligand PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jul 2008 (actual)
- First posted
- 26 Feb 2008 (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 purpose of this study is to demonstrate the safety, tolerability, efficacy and pharmacokinetics of aplindore in patients with early stage Parkinson's Disease (PD) who are not currently taking any dopamine agonists or who are able to wash off dopamine agonists for 14 days prior to baseline. Efficacy will be assessed using the UPDRS questionnaire including part 3 of the UPDRS (Motor). their level of sleepiness on a standardized rating scale (Epworth Sleepiness Scale) and their level of nausea daily.
Safety endpoints will include adverse events (AEs), clinical laboratory data, vital signs (blood pressure, orthostatic blood pressure and heart rate), ECGs, physical examinations and self rated scales.
Detailed description
The purpose of this study is to demonstrate the safety, tolerability, efficacy and pharmacokinetics of aplindore in 5 groups of 8 patients each with early stage Parkinson's Disease (PD) based on Modified Hoehn and Yahr 1-3, who are not currently taking any dopamine agonists or who are able to wash off dopamine agonists for 14 days prior to baseline. Of the 8 patients in each cohort, 6 will be randomized to receive aplindore and two will receive placebo. The initial cohort of patients will be in the study unit from day -1 through day 15 (~2 weeks). After a review of safety labs and ECGs for Day -1, patients will begin twice a day dosing of investigational product on Day 1 with dosing to be given at within 30 minutes of completing breakfast and dinner, approximately 0700 and 1900.
A full UPDRS evaluation will be conducted at screen and on days -1, 7 and 14. In addition part 3 of the UPDRS (Motor) will be collected daily 2 hours after the morning dose of aplindore/placebo. At screening through discharge patients will be asked to self rate their level of sleepiness on a standardized rating scale (Epworth Sleepiness Scale) and their level of nausea daily 2 hours after the time of the morning dose of aplindore/placebo.
Safety endpoints will include adverse events (AEs), clinical laboratory data, vital signs (blood pressure, orthostatic blood pressure and heart rate), ECGs, physical examinations and self rated scales.
This study is a Phase II, dose-ranging, multi-center, placebo-controlled, double-blind, titration study to determine the safety, tolerability, efficacy and pharmacokinetics of aplindore in 5 groups of 8 patients each with early stage Parkinson's Disease (PD) based on Modified Hoehn and Yahr 1-3, who are not currently taking any dopamine agonists or who are able to wash off dopamine agonists for 14 days prior to baseline. Of the 8 patients in each cohort, 6 will be randomized to receive aplindore and two will receive placebo. The minimum number of patients required to initiate a cohort is 6 patients (4 randomized to aplindore and 2 to placebo). The patients in each cohort will be randomized in blocks of 4. Each site will recruit a full cohort of 6-8 patients per dose-titration regimen. There will be no sharing of cohorts/dose regimens across sites.
Early PD patients will be screened and 6-8 eligible patients will be housed in the study unit from day -1 through day 15 or until dismissed by the investigator. After a repeat of safety labs and ECG, patients will begin q12h dosing of investigational product (IP) with dosing to be given at within 30 minutes of completing breakfast and dinner, approximately 0700 and 1900 starting on Day 1. Doses will be escalated according to a predefined schedule. Two hours after each morning dose, a UPDRS part III will be performed. Safety will be ascertained by adverse events, ECGs, orthostatic vitals, physical and neurological exams, safety labs, Epworth Sleepiness Scale and Non Motor Symptoms Questionnaires. One blood sample for PK will be taken on each escalation day, 11 samples at steady state. ECGs and vital signs (semi-reclined and standing) will be collected each day at 2 hours post morning dosing. Adverse events will be collected throughout the inpatient stay. Patients will be down titrated upon reaching an intolerable dose. Patients on prior dopaminergic medications will resume their prior therapies on Day 15. Those patients not on prior dopaminergic medications will be down titrated over 5-7 days in the research clinic. Outpatient safety follow up will be 7-21 days after the last dose of study medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: AplindoreAplindore titrated to safe and tolerable dose |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female 30 years and above
- 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
- For early stage patients the 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. In addition, they must not have developed motor complications from L-dopa use
- Early stage patients must be modified Hoehn \& Yahr Stage 1 to 3 (inclusive)
- Must have a screening UPDRS (Part III) motor score of at least 10 Patients may be receiving amantadine, anticholinergics, COMT inhibitors and/or MAO-B inhibitor provided the dose was stable for at least 4 weeks prior to screening; dopamine agonists and/or L-dopa/carbidopa are permitted at screening but must be discontinued at least 14 days before baseline
Key exclusion criteria (14 listed)
- A Mini Mental State Examination (MMSE) score < 26
- History or clinical features consistent with an atypical parkinsonian syndrome
- History of surgical intervention for PD
- History of L-dopa-induced motor or non-motor complication
- History of severe allergic or anaphylactic reactions to any drug
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 |
|---|---|---|
| AplindoreTablets .05 - 5 mg BID dosing for 14 days | Drug | 1 |
| PlaceboPlacebo tablets to match the number of active tablets | Drug | 2 |
Primary outcome
Evaluation of safety and tolerability data
Time frame: 3 weeks
1 secondary outcome
Change in UPDRS Motor (Part III) score, UPDRS Activities of Daily Living (ADL; Part II), the Non-Motor Symptoms Questionnaire, and the Epworth Sleepiness Scale (ESS) and nausea Likert Scale.
Time frame: 3 weeks
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 3 Oct 2011.
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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 study testing Aplindore in people with Early Stage Parkinson's Disease, run by Ligand Pharmaceuticals 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 14 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 3 Oct 2011. 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 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?
Evaluation of safety and tolerability data (time frame: 3 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 3 Oct 2011.