Akathisia, Drug-InducedPhase 2NCT00686699
Study of Preladenant for the Treatment of Antipsychotic Induced Movement Disorders in Participants With Schizophrenia (Study P04628)
A Phase 2 study testing Preladenant in people with Akathisia, Drug-Induced and Dyskinesia, Drug-Induced, run by Merck Sharp & Dohme LLC.
Trial summary
This study was designed to determine if preladenant (SCH 420814, MK-3814) can reduce drug-induced involuntary movements in participants with schizophrenia or schizoaffective disorder. Participants were to be evaluated for two 14-day treatment periods with a 3-week washout period between treatment periods. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Akathisia, Drug-Induced, Dyskinesia, Drug-Induced, Parkinsonian Disorders
- What is being tested?
- Preladenant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2006to 6 Mar 2008
- Phase
- Phase 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females >=18 and <=65 years old with a body mass index of 17-31 kg/m^2.
- Diagnosed with Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV) criteria for schizophrenia/schizoaffective (depressive type) disorder with antipsychotic-induced extrapyramidal symptoms (parkinsonism, akathisia, dystonia, or tardive dyskinesia [TD]) based on the following ESRS criteria:
- parkinsonism, dystonia, or TD - ESRS score >=2 on 2 items or >=3 on one item,
- akathisia - ESRS score >=3 on two items,
- Has total ESRS score >8.
- Must be receiving neuroleptics at a stable dosage for at least 7 days prior to enrollment.
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- Clinical laboratory tests, physical exam, and electrocardiogram must be within normal limits or clinically acceptable to the investigator/sponsor (except signs and symptoms of Schizophrenia/Schizoaffective disorder).
- Liver function tests must be within normal limits at screening.
- Participant screening for drugs with a high potential for abuse must be negative.
- Must be free of any clinically significant disease other than schizophrenia/schizoaffective disorder that would interfere with the study evaluations or procedures.
- Must have a level of understanding sufficient to communicate with research staff, cooperate with all protocol required tests and examinations, and be able to adhere to protocol restrictions and schedules.
- Must be able to understand the nature of the study and must be willing to sign an informed consent (required for each patient or the patient's authorized legal representative) prior to study enrollment.
- Females must have a follicle stimulating hormone (FSH) >=40 lU/L and be greater than 12 months since last menses or surgically sterilized.
Who cannot join
- Has a history of clinically significant local or systemic infectious disease within 4 weeks prior to initial treatment administration, clinically significant food or drug allergy, seizures, alcohol/drug dependence, previous neurosurgery, or coronary artery disease (including myocardial infarction [MI], cerebrovascular disease [stroke, transient ischemic attack (TIA)], or peripheral arterial disease).
- Has participated in a clinical trial of an investigational drug within 60 days or donated blood within the preceding 90 days prior to the start of the study.
- Has circulating human immunodeficiency virus (HIV), hepatitis C antibodies, or hepatitis B surface antigen.
- Is allergic to preladenant (SCH 420814, MK-3814) or any excipients in preladenant capsules (citric acid, lactose monohydrate, croscarmellose sodium, magnesium stearate [nonbovine, vegetable grade], Food, Drug, and Cosmetic [FD\&C] blue, titanium dioxide, gelatin-national formulary [NF]).
- Females who are not surgically sterilized or postmenopausal.
- Males who are sexually active and who do not agree to use a barrier method of birth control during the study.
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- Has severe/uncontrolled hypertension. (Participants with hypertension well controlled on a stable dose of standard anti-hypertensive medication for at least 4 weeks before randomization are eligible.)
- Has atrioventricular (AV) block, sick sinus syndrome, congestive heart failure, or participants with electrocardiograms (ECGs) consistent with ischemic heart disease, or significant Q waves.
- Has DSM-IV criteria of dementia (except due to schizophrenia/and schizoaffective disorder), or individuals who in the opinion of the investigator are not able to understand or comply with the study procedures or the instructions of the staff or are socially incapable to participate in the study.
- Does not comply with the requirement that participants should not use any drugs (except acetaminophen and other allowed medications) within 2 weeks prior to the study, nor alcohol (wine, beer) within 72 hours prior to drug administration.
- Judged clinically to be at suicidal risk too serious to be included in this study.
- Has received electroconvulsive therapy within 30 days before randomization.
- Is currently taking clozapine.
About this study
Official title: A Phase 2a, Multiple Dose, Placebo Controlled, Randomized, Two Way Crossover Study to Assess the Efficacy of SCH 420814 in Reducing Anti Psychotic-Induced Extra Pyramidal Symptoms Among Subjects With Schizophrenia and Schizoaffective Disorders
This study was designed to determine if preladenant (SCH 420814, MK-3814) can reduce drug-induced involuntary movements in participants with schizophrenia or schizoaffective disorder. Participants were to be evaluated for two 14-day treatment periods with a 3-week washout period between treatment periods. The primary outcome measure, Extrapyramidal Symptom Rating Score (ESRS), was to be evaluated frequently during the treatment periods.
- Being tested
- Preladenant, Placebo
- Keywords
- Anti-Dyskinesia Agents, Antipsychotic Agents
- Medical subject headings
- Akathisia, Drug-Induced, Dyskinesia, Drug-Induced, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PreladenantDrug
Also called SCH 420814, MK-3814
capsules
PlaceboDrug
capsules
| Study group | Role | What they receive |
|---|---|---|
| Preladenant 25 mg BID→Placebo BID | Experimental | Participants received one preladenant 25 mg capsule twice daily (BID) for 14 days during the first treatment period and received one matching placebo capsule BID during the second treatment period. The 2 treatment periods were separated by a 3-week washout period. Receives: Drug: Preladenant |
| Placebo BID→Preladenant 25 mg BID | Placebo comparator | Participants received one matching placebo capsule BID for 14 days during the first treatment period and received one preladenant 25 mg capsule during the second treatment period. The 2 treatment periods were separated by a 3-week washout period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowest Extrapyramidal Symptom Rating Score (ESRS) Total Score Within the 6-hour Evaluation on Day 14 of Each Treatment Period
The ESRS total score consists of 4 subscales: 1) a questionnaire of extrapyramidal symptoms (EPS) and drug-induced movement disorders (DIMD) over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). The ESRS total score could range from 0 to 225, with a lower score reflecting a better outcome. The lowest ESRS total score for each participant within the 6-hour range on Day 14 was analyzed.
Measured: Up to 6 hours post-dose on Day 14
Secondary outcomes (9)
Mean ESRS Total Scores Within the 6-hour Evaluation on Day 14 of Each Treatment Period
The ESRS total score consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). The ESRS total score could range from 0 to 225, with a lower score reflecting a better outcome. The mean ESRS total scores at Hours 1, 2, 3, 4, 5, and 6 on Day 14 were analyzed.
Measured: 1, 2, 3, 4, 5, and 6 hours post-dose on Day 14
Lowest ESRS Part I Subscore: EPS and DIMD Within the 6-hour Evaluation on Day 14 of Each Treatment Period
The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The lowest subscale score on Day 14 was analyzed.
Measured: Up to 6 hours post-dose on Day 14
Mean ESRS Part I Subscore: EPS and DIMD Within the 6-hour Evaluation on Day 14 of Each Treatment Period
The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The mean subscores at Hours 1, 2, 3, 4, 5 and 6 on Day 14 were analyzed.
Measured: 1, 2, 3, 4, 5, and 6 hours post-dose on Day 14
Lowest ESRS Part II Subscore: Parkinsonism and Akathisia Within the 6-hour Evaluation on Day 14 of Each Treatment Period
The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The lowest subscale score on Day 14 was analyzed.
Measured: Up to 6 hours post-dose on Day 14
Mean ESRS Part II Subscores: Parkinsonism and Akathisia Within the 6-hour Evaluation on Day 14 of Each Treatment Period
The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The mean subscores at Hours 1, 2, 3, 4, 5 and 6 on Day 14 were analyzed.
Measured: 1, 2, 3, 4, 5, and 6 hours post-dose on Day 14
Lowest ESRS Part III Subscore: Dystonia Within the 6-hour Evaluation on Day 14 of Each Treatment Period
The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The lowest subscale score on Day 14 was analyzed.
Measured: Up to 6 hours post-dose on Day 14
Mean ESRS Part III Subscores: Dystonia Within the 6-hour Evaluation on Day 14 of Each Treatment Period
The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The mean subscores at Hours 1, 2, 3, 4, 5 and 6 on Day 14 were analyzed.
Measured: 1, 2, 3, 4, 5, and 6 hours post-dose on Day 14
Lowest ESRS Part IV Subscore: Dyskinesia Within the 6-hour Evaluation on Day 14 of Each Treatment Period
The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The lowest subscale score on Day 14 was analyzed.
Measured: Up to 6 hours post-dose on Day 14
Mean ESRS Part IV Subscores: Dyskinesia Within the 6-hour Evaluation on Day 14 of Each Treatment Period
The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The mean subscores at Hours 1, 2, 3, 4, 5 and 6 on Day 14 were analyzed.
Measured: 1, 2, 3, 4, 5, and 6 hours post-dose on Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
- Study start10 Jul 2006
- Primary completion6 Mar 2008
- Study completion6 Mar 2008
Why it stopped: The study was terminated after 9 participants completed due to lack of enrollment for 6 months.
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 Akathisia, Drug-InducedStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686699
- Sponsor's protocol ID
- P04628
- Other IDs
- 2005-006048-42, MK-3814-014, 2005
- Status last verified
- Oct 2018
- First submitted
- 27 May 2008
- Last updated
- 9 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Multiple Dose, Placebo Controlled, Randomized, Two Way Crossover Study to Assess the Efficacy of SCH 420814 in Reducing Anti Psychotic-Induced Extra Pyramidal Symptoms Among Subjects With Schizophrenia and Schizoaffective Disorders
- ClinicalTrials.gov ID
- NCT00686699
- Acronym / sponsor ID
- P04628
- Keywords
- Anti-Dyskinesia Agents, Antipsychotic Agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated after 9 participants completed due to lack of enrollment for 6 months.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2006 (actual)
- Primary completion
- 6 Mar 2008 (actual)
- Study completion
- 6 Mar 2008 (actual)
- First posted
- 30 May 2008 (estimated)
- Results
- Posted 7 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to determine if preladenant (SCH 420814, MK-3814) can reduce drug-induced involuntary movements in participants with schizophrenia or schizoaffective disorder. Participants were to be evaluated for two 14-day treatment periods with a 3-week washout period between treatment periods. The primary outcome measure, Extrapyramidal Symptom Rating Score (ESRS), was to be evaluated frequently during the treatment periods.
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 |
|---|---|---|
| Preladenant 25 mg BID→Placebo BID | Experimental | Drug: PreladenantParticipants received one preladenant 25 mg capsule twice daily (BID) for 14 days during the first treatment period and received one matching placebo capsule BID during the second treatment period. The 2 treatment periods were separated by a 3-week washout period. |
| Placebo BID→Preladenant 25 mg BID | Placebo comparator | Drug: PlaceboParticipants received one matching placebo capsule BID for 14 days during the first treatment period and received one preladenant 25 mg capsule during the second treatment period. The 2 treatment periods were separated by a 3-week washout period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Males or females >=18 and <=65 years old with a body mass index of 17-31 kg/m^2.
- Diagnosed with Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV) criteria for schizophrenia/schizoaffective (depressive type) disorder with antipsychotic-induced extrapyramidal symptoms (parkinsonism, akathisia, dystonia, or tardive dyskinesia [TD]) based on the following ESRS criteria:
- Has total ESRS score >8.
- Must be receiving neuroleptics at a stable dosage for at least 7 days prior to enrollment.
- Clinical laboratory tests, physical exam, and electrocardiogram must be within normal limits or clinically acceptable to the investigator/sponsor (except signs and symptoms of Schizophrenia/Schizoaffective disorder).
Key exclusion criteria (13 listed)
- Has a history of clinically significant local or systemic infectious disease within 4 weeks prior to initial treatment administration, clinically significant food or drug allergy, seizures, alcohol/drug dependence, previous neurosurgery, or coronary artery disease (including myocardial infarction [MI], cerebrovascular disease [stroke, transient ischemic attack (TIA)], or peripheral arterial disease).
- Has participated in a clinical trial of an investigational drug within 60 days or donated blood within the preceding 90 days prior to the start of the study.
- Has circulating human immunodeficiency virus (HIV), hepatitis C antibodies, or hepatitis B surface antigen.
- Is allergic to preladenant (SCH 420814, MK-3814) or any excipients in preladenant capsules (citric acid, lactose monohydrate, croscarmellose sodium, magnesium stearate [nonbovine, vegetable grade], Food, Drug, and Cosmetic [FD\&C] blue, titanium dioxide, gelatin-national formulary [NF]).
- Females who are not surgically sterilized or postmenopausal.
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 |
|---|---|---|
| PreladenantAlso: SCH 420814, MK-3814capsules | Drug | Preladenant 25 mg BID→Placebo BID |
| Placebocapsules | Drug | Placebo BID→Preladenant 25 mg BID |
Primary outcome
Lowest Extrapyramidal Symptom Rating Score (ESRS) Total Score Within the 6-hour Evaluation on Day 14 of Each Treatment Period
Time frame: Up to 6 hours post-dose on Day 14
The ESRS total score consists of 4 subscales: 1) a questionnaire of extrapyramidal symptoms (EPS) and drug-induced movement disorders (DIMD) over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). The ESRS total score could range from 0 to 225, with a lower score reflecting a better outcome. The lowest ESRS total score for each participant within the 6-hour range on Day 14 was analyzed.
9 secondary outcomes
Mean ESRS Total Scores Within the 6-hour Evaluation on Day 14 of Each Treatment Period
Time frame: 1, 2, 3, 4, 5, and 6 hours post-dose on Day 14
Lowest ESRS Part I Subscore: EPS and DIMD Within the 6-hour Evaluation on Day 14 of Each Treatment Period
Time frame: Up to 6 hours post-dose on Day 14
Mean ESRS Part I Subscore: EPS and DIMD Within the 6-hour Evaluation on Day 14 of Each Treatment Period
Time frame: 1, 2, 3, 4, 5, and 6 hours post-dose on Day 14
Lowest ESRS Part II Subscore: Parkinsonism and Akathisia Within the 6-hour Evaluation on Day 14 of Each Treatment Period
Time frame: Up to 6 hours post-dose on Day 14
Mean ESRS Part II Subscores: Parkinsonism and Akathisia Within the 6-hour Evaluation on Day 14 of Each Treatment Period
Time frame: 1, 2, 3, 4, 5, and 6 hours post-dose on Day 14
Lowest ESRS Part III Subscore: Dystonia Within the 6-hour Evaluation on Day 14 of Each Treatment Period
Time frame: Up to 6 hours post-dose on Day 14
Mean ESRS Part III Subscores: Dystonia Within the 6-hour Evaluation on Day 14 of Each Treatment Period
Time frame: 1, 2, 3, 4, 5, and 6 hours post-dose on Day 14
Lowest ESRS Part IV Subscore: Dyskinesia Within the 6-hour Evaluation on Day 14 of Each Treatment Period
Time frame: Up to 6 hours post-dose on Day 14
Mean ESRS Part IV Subscores: Dyskinesia Within the 6-hour Evaluation on Day 14 of Each Treatment Period
Time frame: 1, 2, 3, 4, 5, and 6 hours post-dose on Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Preladenant in people with Akathisia, Drug-Induced and Dyskinesia, Drug-Induced, run by Merck Sharp & Dohme LLC.
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 13 inclusion and 13 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: stopped early, as of the sponsor's last update on 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 7 Dec 2016). 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?
Lowest Extrapyramidal Symptom Rating Score (ESRS) Total Score Within the 6-hour Evaluation on Day 14 of Each Treatment Period (time frame: Up to 6 hours post-dose on Day 14). 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 Nov 2018.